Neurontin - A Medical Dictionary, Bibliography, and Annotated Research Guide to Internet References

NEURONTIN A M EDICAL D ICTIONARY , B IBLIOGRAPHY , AND A NNOTATED R ESEARCH G UIDE TO I NTERNET R E FERENCES

J AMES N. P ARKER , M.D. AND P HILIP M. P ARKER , P H .D., E DITORS

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ICON Health Publications ICON Group International, Inc. 4370 La Jolla Village Drive, 4th Floor San Diego, CA 92122 USA Copyright 2003 by ICON Group International, Inc. Copyright 2003 by ICON Group International, Inc. All rights reserved. This book is protected by copyright. No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without written permission from the publisher. Printed in the United States of America. Last digit indicates print number: 10 9 8 7 6 4 5 3 2 1

Publisher, Health Care: Philip Parker, Ph.D. Editor(s): James Parker, M.D., Philip Parker, Ph.D. Publisher's note: The ideas, procedures, and suggestions contained in this book are not intended for the diagnosis or treatment of a health problem. As new medical or scientific information becomes available from academic and clinical research, recommended treatments and drug therapies may undergo changes. The authors, editors, and publisher have attempted to make the information in this book up to date and accurate in accord with accepted standards at the time of publication. The authors, editors, and publisher are not responsible for errors or omissions or for consequences from application of the book, and make no warranty, expressed or implied, in regard to the contents of this book. Any practice described in this book should be applied by the reader in accordance with professional standards of care used in regard to the unique circumstances that may apply in each situation. The reader is advised to always check product information (package inserts) for changes and new information regarding dosage and contraindications before prescribing any drug or pharmacological product. Caution is especially urged when using new or infrequently ordered drugs, herbal remedies, vitamins and supplements, alternative therapies, complementary therapies and medicines, and integrative medical treatments. Cataloging-in-Publication Data Parker, James N., 1961Parker, Philip M., 1960Neurontin: A Medical Dictionary, Bibliography, and Annotated Research Guide to Internet References / James N. Parker and Philip M. Parker, editors p. cm. Includes bibliographical references, glossary, and index. ISBN: 0-597-83631-0 1. Neurontin-Popular works. I. Title.

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Disclaimer This publication is not intended to be used for the diagnosis or treatment of a health problem. It is sold with the understanding that the publisher, editors, and authors are not engaging in the rendering of medical, psychological, financial, legal, or other professional services. References to any entity, product, service, or source of information that may be contained in this publication should not be considered an endorsement, either direct or implied, by the publisher, editors, or authors. ICON Group International, Inc., the editors, and the authors are not responsible for the content of any Web pages or publications referenced in this publication.

Copyright Notice If a physician wishes to copy limited passages from this book for patient use, this right is automatically granted without written permission from ICON Group International, Inc. (ICON Group). However, all of ICON Group publications have copyrights. With exception to the above, copying our publications in whole or in part, for whatever reason, is a violation of copyright laws and can lead to penalties and fines. Should you want to copy tables, graphs, or other materials, please contact us to request permission (E-mail: [email protected]). ICON Group often grants permission for very limited reproduction of our publications for internal use, press releases, and academic research. Such reproduction requires confirmed permission from ICON Group International Inc. The disclaimer above must accompany all reproductions, in whole or in part, of this book.

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Acknowledgements The collective knowledge generated from academic and applied research summarized in various references has been critical in the creation of this book which is best viewed as a comprehensive compilation and collection of information prepared by various official agencies which produce publications on Neurontin. Books in this series draw from various agencies and institutions associated with the United States Department of Health and Human Services, and in particular, the Office of the Secretary of Health and Human Services (OS), the Administration for Children and Families (ACF), the Administration on Aging (AOA), the Agency for Healthcare Research and Quality (AHRQ), the Agency for Toxic Substances and Disease Registry (ATSDR), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Healthcare Financing Administration (HCFA), the Health Resources and Services Administration (HRSA), the Indian Health Service (IHS), the institutions of the National Institutes of Health (NIH), the Program Support Center (PSC), and the Substance Abuse and Mental Health Services Administration (SAMHSA). In addition to these sources, information gathered from the National Library of Medicine, the United States Patent Office, the European Union, and their related organizations has been invaluable in the creation of this book. Some of the work represented was financially supported by the Research and Development Committee at INSEAD. This support is gratefully acknowledged. Finally, special thanks are owed to Tiffany Freeman for her excellent editorial support.

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About the Editors James N. Parker, M.D. Dr. James N. Parker received his Bachelor of Science degree in Psychobiology from the University of California, Riverside and his M.D. from the University of California, San Diego. In addition to authoring numerous research publications, he has lectured at various academic institutions. Dr. Parker is the medical editor for health books by ICON Health Publications. Philip M. Parker, Ph.D. Philip M. Parker is the Eli Lilly Chair Professor of Innovation, Business and Society at INSEAD (Fontainebleau, France and Singapore). Dr. Parker has also been Professor at the University of California, San Diego and has taught courses at Harvard University, the Hong Kong University of Science and Technology, the Massachusetts Institute of Technology, Stanford University, and UCLA. Dr. Parker is the associate editor for ICON Health Publications.

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About ICON Health Publications To discover more about ICON Health Publications, simply check with your preferred online booksellers, including Barnes & Noble.com and Amazon.com which currently carry all of our titles. Or, feel free to contact us directly for bulk purchases or institutional discounts: ICON Group International, Inc. 4370 La Jolla Village Drive, Fourth Floor San Diego, CA 92122 USA Fax: 858-546-4341 Web site: www.icongrouponline.com/health

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Table of Contents FORWARD .......................................................................................................................................... 1 CHAPTER 1. STUDIES ON NEURONTIN .............................................................................................. 3 Overview........................................................................................................................................ 3 The Combined Health Information Database................................................................................. 3 Federally Funded Research on Neurontin ..................................................................................... 4 E-Journals: PubMed Central ......................................................................................................... 8 The National Library of Medicine: PubMed .................................................................................. 8 CHAPTER 2. NUTRITION AND NEURONTIN .................................................................................... 25 Overview...................................................................................................................................... 25 Finding Nutrition Studies on Neurontin .................................................................................... 25 Federal Resources on Nutrition ................................................................................................... 29 Additional Web Resources ........................................................................................................... 30 CHAPTER 3. ALTERNATIVE MEDICINE AND NEURONTIN .............................................................. 33 Overview...................................................................................................................................... 33 National Center for Complementary and Alternative Medicine.................................................. 33 Additional Web Resources ........................................................................................................... 36 General References ....................................................................................................................... 37 CHAPTER 4. CLINICAL TRIALS AND NEURONTIN .......................................................................... 39 Overview...................................................................................................................................... 39 Recent Trials on Neurontin ......................................................................................................... 39 Keeping Current on Clinical Trials ............................................................................................. 43 CHAPTER 5. PATENTS ON NEURONTIN........................................................................................... 45 Overview...................................................................................................................................... 45 Patents on Neurontin .................................................................................................................. 45 Patent Applications on Neurontin............................................................................................... 52 Keeping Current .......................................................................................................................... 58 CHAPTER 6. BOOKS ON NEURONTIN .............................................................................................. 59 Overview...................................................................................................................................... 59 The National Library of Medicine Book Index ............................................................................. 59 Chapters on Neurontin ................................................................................................................ 60 CHAPTER 7. PERIODICALS AND NEWS ON NEURONTIN ................................................................ 63 Overview...................................................................................................................................... 63 News Services and Press Releases................................................................................................ 63 Newsletter Articles ...................................................................................................................... 66 Academic Periodicals covering Neurontin................................................................................... 67 APPENDIX A. PHYSICIAN RESOURCES ............................................................................................ 71 Overview...................................................................................................................................... 71 NIH Guidelines............................................................................................................................ 71 NIH Databases............................................................................................................................. 73 Other Commercial Databases....................................................................................................... 75 APPENDIX B. PATIENT RESOURCES ................................................................................................. 77 Overview...................................................................................................................................... 77 Patient Guideline Sources............................................................................................................ 77 Finding Associations.................................................................................................................... 80 APPENDIX C. FINDING MEDICAL LIBRARIES .................................................................................. 83 Overview...................................................................................................................................... 83 Preparation................................................................................................................................... 83 Finding a Local Medical Library.................................................................................................. 83 Medical Libraries in the U.S. and Canada ................................................................................... 83 ONLINE GLOSSARIES.................................................................................................................. 89

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Contents Online Dictionary Directories ..................................................................................................... 89

NEURONTIN DICTIONARY........................................................................................................ 91 INDEX .............................................................................................................................................. 109

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FORWARD In March 2001, the National Institutes of Health issued the following warning: "The number of Web sites offering health-related resources grows every day. Many sites provide valuable information, while others may have information that is unreliable or misleading."1 Furthermore, because of the rapid increase in Internet-based information, many hours can be wasted searching, selecting, and printing. Since only the smallest fraction of information dealing with Neurontin is indexed in search engines, such as www.google.com or others, a non-systematic approach to Internet research can be not only time consuming, but also incomplete. This book was created for medical professionals, students, and members of the general public who want to know as much as possible about Neurontin, using the most advanced research tools available and spending the least amount of time doing so. In addition to offering a structured and comprehensive bibliography, the pages that follow will tell you where and how to find reliable information covering virtually all topics related to Neurontin, from the essentials to the most advanced areas of research. Public, academic, government, and peer-reviewed research studies are emphasized. Various abstracts are reproduced to give you some of the latest official information available to date on Neurontin. Abundant guidance is given on how to obtain free-of-charge primary research results via the Internet. While this book focuses on the field of medicine, when some sources provide access to non-medical information relating to Neurontin, these are noted in the text. E-book and electronic versions of this book are fully interactive with each of the Internet sites mentioned (clicking on a hyperlink automatically opens your browser to the site indicated). If you are using the hard copy version of this book, you can access a cited Web site by typing the provided Web address directly into your Internet browser. You may find it useful to refer to synonyms or related terms when accessing these Internet databases. NOTE: At the time of publication, the Web addresses were functional. However, some links may fail due to URL address changes, which is a common occurrence on the Internet. For readers unfamiliar with the Internet, detailed instructions are offered on how to access electronic resources. For readers unfamiliar with medical terminology, a comprehensive glossary is provided. For readers without access to Internet resources, a directory of medical libraries, that have or can locate references cited here, is given. We hope these resources will prove useful to the widest possible audience seeking information on Neurontin. The Editors

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From the NIH, National Cancer Institute (NCI): http://www.cancer.gov/cancerinfo/ten-things-to-know.

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CHAPTER 1. STUDIES ON NEURONTIN Overview In this chapter, we will show you how to locate peer-reviewed references and studies on Neurontin.

The Combined Health Information Database The Combined Health Information Database summarizes studies across numerous federal agencies. To limit your investigation to research studies and Neurontin, you will need to use the advanced search options. First, go to http://chid.nih.gov/index.html. From there, select the “Detailed Search” option (or go directly to that page with the following hyperlink: http://chid.nih.gov/detail/detail.html). The trick in extracting studies is found in the drop boxes at the bottom of the search page where “You may refine your search by.” Select the dates and language you prefer, and the format option “Journal Article.” At the top of the search form, select the number of records you would like to see (we recommend 100) and check the box to display “whole records.” We recommend that you type “Neurontin” (or synonyms) into the “For these words:” box. Consider using the option “anywhere in record” to make your search as broad as possible. If you want to limit the search to only a particular field, such as the title of the journal, then select this option in the “Search in these fields” drop box. The following is what you can expect from this type of search: •

Gabapentin for the Symptomatic Treatment of Painful Neuropathy in Patients with Diabetes Mellitus: A Randomized Controlled Trial Source: JAMA. Journal of the American Medical Association. 280(21): 1831-1836. December 2, 1998. Summary: Pain is the most disturbing symptom of diabetic peripheral neuropathy (disease or deterioration of the nerves), a problem in up to 45 percent of patients with diabetes mellitus. Pain due to diabetic neuropathy affects the feet and ankles most often and, to a lesser extent, lower extremities above the knees and upper extremities. This article reports on a study undertaken to evaluate the effect of gabapentin (Neurontin) monotherapy on the pain associated with diabetic peripheral neuropathy. The randomized, double blind, placebo controlled, 8 week trial included 165 patients enrolled at outpatient clinics at 20 sites. The patients all had a 1 to 5 year history of pain

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attributed to diabetic neuropathy and a minimum pain score on an evaluation instrument (Short Form McGill Pain Questionnaire visual analog scale). Patients (n = 81) received gabapentin or placebo (n = 81); of these, 70 patients receiving gabapentin completed the study and 60 patients receiving placebo completed the study. By intent to treat analysis, gabapentin treated patients' mean daily pain score at the study end point was significantly lower compared with the placebo treated patients' end point score. All secondary outcome measures of pain were significantly better in the gabapentin group than in the placebo group. Additional statistically significant differences favoring gabapentin treatment were observed in measures of quality of life. Adverse events experienced significantly more frequently in the gabapentin group were dizziness and somnolence (sleepiness). The authors conclude that gabapentin monotherapy appears to be effective for the treatment of pain and sleep interference associated with diabetic peripheral neuropathy and exhibits positive effects on mood and quality of life. 4 figures. 3 tables. 42 references.

Federally Funded Research on Neurontin The U.S. Government supports a variety of research studies relating to Neurontin. These studies are tracked by the Office of Extramural Research at the National Institutes of Health.2 CRISP (Computerized Retrieval of Information on Scientific Projects) is a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other institutions. Search the CRISP Web site at http://crisp.cit.nih.gov/crisp/crisp_query.generate_screen. You will have the option to perform targeted searches by various criteria, including geography, date, and topics related to Neurontin. For most of the studies, the agencies reporting into CRISP provide summaries or abstracts. As opposed to clinical trial research using patients, many federally funded studies use animals or simulated models to explore Neurontin. The following is typical of the type of information found when searching the CRISP database for Neurontin: •

Project Title: GABAPENTIN DETOXIFICATION

AND

LORAZEPAM

IN

OUTPATIENT

Principal Investigator & Institution: Malcolm, Robert J.; Professor; Medical University of South Carolina 171 Ashley Ave Charleston, SC 29425 Timing: Fiscal Year 2001; Project Start 10-DEC-1995; Project End 30-NOV-2005 Summary: The alcohol withdrawal syndrome (AWS) has been treated for nearly forty years with the remarkably safe and effective benzodiazepines (BZs). In the outpatient treatment of AWS, interactions with alcohol and the abuse liability of BZs invite comparisons with agents that do not share these susceptibilities. In our original Alcohol Research Center component comparing Lorazepam (LZ) to Carbamazepine (CBZ), the latter was significantly more effective in suppressing the acoustic startle response, and anxiety and depressive symptoms during treatment. In the immediate seven-day post treatment, LZ subjects showed higher levels of multiple dimensions of AWS symptoms, 2 Healthcare projects are funded by the National Institutes of Health (NIH), Substance Abuse and Mental Health Services (SAMHSA), Health Resources and Services Administration (HRSA), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDCP), Agency for Healthcare Research and Quality (AHRQ), and Office of Assistant Secretary of Health (OASH).

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including higher withdrawal scores, poor sleep, and greater subjective discomfort than CBZ. CBZ, useful in research has limited clinical applications because of its widespread interactions and uncommon but serious toxicities. In the present application, we propose a double-blind controlled trial of gabapentin (GBP, 80) vs. LZ (N=80) in treatment seeking outpatients experiencing AWS. Multiple domains of AWS will be evaluated during a five-day outpatient treatment interval and a seven-day post treatment phase. Serial measures include electrophysiologic tests of eye blink acoustic startle response, aggregate withdrawal symptoms as evaluated by the CIWA-Ar, subjective assessments of sleep, global discomfort, anxiety, depression, and need for additional medications. Side effects and safety will be compared. GMP, a unique anticonvulsant, is not a controlled substance, soon will be generic, has benign side effects, has no interactions with other drugs, and has limited interactions with alcohol. Side effects and safety will be compared. GBP, a unique anticonvulsant, is not a controlled substance, soon will be generic, has benign side effects, has no interactions with other drugs, and has limited interactions with alcohol. Should GBP be superior to LZ for the treatment of AWS, it could revise the way AWS is managed in outpatients. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen •

Project Title: GABAPENTIN AS AN ADJUNCT TO NALTREXONE FOR ALCOHOLISM Principal Investigator & Institution: Anton, Raymond F.; Professor of Psychiatry; Psychiatry and Behavioral Scis; Medical University of South Carolina 171 Ashley Ave Charleston, SC 29425 Timing: Fiscal Year 2002; Project Start 30-SEP-1992; Project End 31-AUG-2007 Summary: (provided by applicant): Experience gained conducting numerous clinical trials with alcoholics has provided the infrastructure and knowledge for us to address novel treatments in a scientifically vigorous manner. In particular, we have found naltrexone to be efficacious when combined with cognitive behavioral therapy (CBT) and are currently investigating its efficacy when combined with either CBT or motivational enhancement therapy. In both studies, comprising over 250 individuals, most relapse occurs during early treatment (during the first six weeks) during which individuals complain of sleep difficulty, irritability and nervousness. These symptoms are indicative of brain dysregulation and may be related to "protracted alcohol withdrawal". Gabapentin, a safe and effective FDA approved antiseizure compound used in millions of individuals worldwide, can reduce glutamate and increase GABA neurotransmission in the brain. This unique pharmacology is well suited to the treatment of alcohol withdrawal and could normalize the brain dysregulation seen during the early abstinence period. A number of pre-clinical and clinical studies at our Center have indicated that it can reduce alcohol withdrawal symptoms, reduce drinking in dependent animals, and is safe to use in the clinic. We purpose a randomized double blind clinical trial, to evaluate the adjunctive use of gabapentin with naltrexone for the treatment of alcohol dependent individuals using a three group (placebo alone, placebo plus naltrexone, gabapentin plus naltrexone) design. Gabapentin or placebo will be added to naltrexone for the first six weeks of treatment (the time of greatest relapse and of potential 'protracted withdrawal" symptoms). Naltrexone and/or placebo treatment will last 16 weeks and all subjects will receive Combined Behavioral Intervention as developed for the COMBINE study (in which we are participating). It is predicted that alcoholics receiving naltrexone and adjunctive gabapentin will have less relapse than those treated with naltrexone alone. Measures of mood, sleep, irritability, and anxiety will be compared between treatment groups. Evaluations occur during treatment and 12

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weeks and 24 weeks post-treatment. This evaluation of a novel treatment will allow us to better understand combined pharmacotherapy and develop a new paradigm for medications development for alcoholism. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen •

Project Title: GABAPENTIN THERAPY FOR THE PRURITUS OF CHOLESTASIS Principal Investigator & Institution: Bergasa, Nora V.; Medicine; Columbia University Health Sciences New York, NY 10032 Timing: Fiscal Year 2001; Project Start 15-FEB-2001; Project End 31-JAN-2003 Summary: The etiology of the pruritus of cholestasis is unknown and its treatment unsatisfactory. The pruritus of cholestasis has a negative impact on the quality of life of patients and can be so severe that it can be an indication for liver transplantation, ever in the face of good hepatic function. Accordingly, the provision of satisfactory treatment for this symptom is needed. Pruritus is a nociceptive stimulus that elicits the reflect act of scratching. Because the perception of nociception can be altered by drugs that mediate antinociception, this type of drugs may be of value in the treatment of pruritus. Recent data from animal and clinical studies suggest that gabapentin mediates antinociception/analgesia. The specific aim of this study is to compare the effect of gabapentin to that of placebo on the pruritus of cholestasis. Adult patients with pruritus secondary to liver disease will be studied, in a single blind, randomized, placebo controlled trial. Because pruritus is a perception, it cannot be objectively quantitated. In contrast, the behavioral manifestation of the pruritus of cholestasis, scratching activity, can be objectively quantitated. The primary end point of this study is scratching activity. Scratching activity will be measured by a stem designed specifically to record this behavior. The potential outcome of this study is the identification of an effective form of therapy for the pruritus of cholestasis. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen

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Project Title: GABAPENTIN TREATMENT OF ALCOHOL DEPENDENCE Principal Investigator & Institution: Mason, Barbara J.; Associate Professor; Scripps Research Institute 10550 N Torrey Pines Rd La Jolla, CA 920371000 Timing: Fiscal Year 2003; Project Start 01-MAR-2003; Project End 28-FEB-2008 Summary: (provided by applicant): Gabapentin is a novel anticonvulsant drug that appears to act on both GABA and glutamate systems to reduce CNS excitability characteristic of early abstinence from alcohol. Clinical reports and controlled trials support the efficacy and safety of gabapentin treatment of depression, anxiety, insomnia and alcohol withdrawal. Acamprosate, another glutamate modulating drug, has been found to increase abstinence in controlled trials of alcohol dependence. Thus, a medication that is functionally similar to acamprosate, with efficacy for alcohol withdrawal and the negative affect and disturbances in sleep that are often associated with relapse, is of interest as a potential relapse-prevention medication in alcohol dependence. The primary aim of this study is to evaluate the safety and efficacy of gabapentin for prolonging abstinence and reducing drinking in recently abstinent outpatients with alcohol dependence. A 12-week, double-blind, placebo-controlled, dose-ranging study will be conducted with random assignment to gabapentin 900 mg/d, 1800 mg/d or placebo. Subjects will be 150 outpatients with alcohol dependence. The 3 pharmacological treatment conditions will be administered in conjunction with manual-guided behavioral counseling that incorporates strategies to increase motivation, abstinence, and medication compliance. Counseling and research

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assessments will occur weekly throughout the 12-week treatment phase. Post-treatment assessments will occur at Weeks 13, 24 and 36. It is hypothesized that administration of gabapentin will result in significantly: 1.) Greater rate of cumulative abstinence duration, 2.) Longer latency to first drink, and 3.) Less alcohol consumption on study than placebo, and will show a linear dose effect. Baseline measures of mood and sleep will be examined as potential predictors of treatment outcome. Results will provide key information about the efficacy and safety of gabapentin for relapse prevention during early abstinence in outpatients with alcohol dependence. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen •

Project Title: GABAPENTIN VS ESTROGEN FOR THE TREATMENT OF HOT FLUSHES Principal Investigator & Institution: Reddy, Sireesha; Obstetrics and Gynecology; University of Rochester Orpa - Rc Box 270140 Rochester, NY 14627 Timing: Fiscal Year 2003; Project Start 01-MAY-2003; Project End 30-APR-2005 Summary: (provided by applicant): Hot flashes and other climacteric symptoms affect 75% of postmenopausal women in the US and are associated with higher rates of depression and sleep disturbance. Although hormone replacement therapy (HRT) is highly effective in reducing hot flashes, there is concern that HRT is associated with an increased risk of thrombo-embolic events, breast cancer and ovarian cancer. In addition, it is poorly tolerated in clinical practice, with about 30% of women discontinuing therapy after a mean of 4.5 months. Many other women have a contraindication to HRT, such as a history of an estrogen-sensitive tumor, liver dysfunction, or a hypercoagulable state. Safe, effective, and well-tolerated alternative therapies for hot flashes are needed. Gabapentin is a gamma-aminobutyric acid (GABA)-analog approved in 1994 for the treatment of seizures. Since then, it has been shown that gabapentin is efficacious for numerous off-label indications such as neuropathic pain, anxiety, bipolar disorder, and migraine headaches. The investigators have reported that gabapentin is associated with a reduction in the frequency of hot flashes in an uncontrolled series of postmenopausal women who were taking gabapentin for other indications. The investigators also report here preliminary data from a randomized, placebo-controlled trial showing that lowdose gabapentin was associated with a greater reduction in hot flash frequency than placebo after 12 weeks of treatment. However, it is not known whether the efficacy of gabapentin in the treatment of hot flashes and other menopausal symptoms is comparable to that of estrogen, the gold standard. A randomized trial of gabapentin, estrogen and placebo is needed to inform clinicians as to whether gabapentin is an effective alternative to estrogen. The first major aim of this proposal is to assess the screening and recruitment of menopausal women into a randomized trial of gabapentin, estrogen and placebo in the treatment of climacteric symptoms. The second major aim is to obtain preliminary estimates of the frequency and severity of climacteric symptoms among women receiving gabapentin, estrogen and placebo. Pilot data from these two aims will permit estimates of sample-size requirements for a full-scale randomized trial, and of the overall feasibility and cost of such a trial. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen

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E-Journals: PubMed Central3 PubMed Central (PMC) is a digital archive of life sciences journal literature developed and managed by the National Center for Biotechnology Information (NCBI) at the U.S. National Library of Medicine (NLM).4 Access to this growing archive of e-journals is free and unrestricted.5 To search, go to http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=Pmc, and type “Neurontin” (or synonyms) into the search box. This search gives you access to full-text articles. The following is a sample of items found for Neurontin in the PubMed Central database: •

Gabapentin induced cholestasis. by Richardson CE. 2002 Sep 21; http://www.pubmedcentral.gov/articlerender.fcgi?tool=pmcentrez&artid=126306

The National Library of Medicine: PubMed One of the quickest and most comprehensive ways to find academic studies in both English and other languages is to use PubMed, maintained by the National Library of Medicine.6 The advantage of PubMed over previously mentioned sources is that it covers a greater number of domestic and foreign references. It is also free to use. If the publisher has a Web site that offers full text of its journals, PubMed will provide links to that site, as well as to sites offering other related data. User registration, a subscription fee, or some other type of fee may be required to access the full text of articles in some journals. To generate your own bibliography of studies dealing with Neurontin, simply go to the PubMed Web site at http://www.ncbi.nlm.nih.gov/pubmed. Type “Neurontin” (or synonyms) into the search box, and click “Go.” The following is the type of output you can expect from PubMed for “Neurontin” (hyperlinks lead to article summaries): •

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A case of cutaneous leukocytoclastic vasculitis associated with gabapentin. Author(s): Poon DY, Law NM. Source: Singapore Med J. 2003 January; 44(1): 42-4. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12762564&dopt=Abstract

Adapted from the National Library of Medicine: http://www.pubmedcentral.nih.gov/about/intro.html.

With PubMed Central, NCBI is taking the lead in preservation and maintenance of open access to electronic literature, just as NLM has done for decades with printed biomedical literature. PubMed Central aims to become a world-class library of the digital age. 5 The value of PubMed Central, in addition to its role as an archive, lies in the availability of data from diverse sources stored in a common format in a single repository. Many journals already have online publishing operations, and there is a growing tendency to publish material online only, to the exclusion of print. 6 PubMed was developed by the National Center for Biotechnology Information (NCBI) at the National Library of Medicine (NLM) at the National Institutes of Health (NIH). The PubMed database was developed in conjunction with publishers of biomedical literature as a search tool for accessing literature citations and linking to full-text journal articles at Web sites of participating publishers. Publishers that participate in PubMed supply NLM with their citations electronically prior to or at the time of publication.

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A postmarketing surveillance study of gabapentin as add-on therapy for 3,100 patients in England. Author(s): Wilton LV, Shakir S. Source: Epilepsia. 2002 September; 43(9): 983-92. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12199723&dopt=Abstract

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A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Author(s): Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. Source: Anesthesiology. 2002 September; 97(3): 560-4. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12218520&dopt=Abstract

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Anorgasmia and withdrawal syndrome in a woman taking gabapentin. Author(s): Drabkin R, Calhoun L. Source: Canadian Journal of Psychiatry. Revue Canadienne De Psychiatrie. 2003 March; 48(2): 125-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12655912&dopt=Abstract

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AUStralian study of titration to effect profile of safety (AUS-STEPS): high-dose gabapentin (neurontin) in partial seizures. Author(s): Beran R, Berkovic S, Black A, Danta G, Dunne J, Frasca J, Grainger K, Kilpatrick C, McKenzie R, McLaughlin D, Schapel G, Somerville E. Source: Epilepsia. 2001 October; 42(10): 1335-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11737169&dopt=Abstract

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Case reports - reversal of sensory deficit associated with pain relief after treatment with gabapentin. Author(s): Chong MS, Smith TE, Hanna M. Source: Pain. 2002 April; 96(3): 329-33. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11973006&dopt=Abstract

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Cellular and molecular action of the putative GABA-mimetic, gabapentin. Author(s): Maneuf YP, Gonzalez MI, Sutton KS, Chung FZ, Pinnock RD, Lee K. Source: Cellular and Molecular Life Sciences : Cmls. 2003 April; 60(4): 742-50. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12785720&dopt=Abstract

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Central post-stroke pain syndrome: yet another use for gabapentin? Author(s): Chen B, Stitik TP, Foye PM, Nadler SF, DeLisa JA. Source: American Journal of Physical Medicine & Rehabilitation / Association of Academic Physiatrists. 2002 September; 81(9): 718-20. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12172525&dopt=Abstract

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Characterization of gabapentin overdose using a poison center case series. Author(s): Klein-Schwartz W, Shepherd JG, Gorman S, Dahl B. Source: Journal of Toxicology. Clinical Toxicology. 2003; 41(1): 11-5. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12645962&dopt=Abstract

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Clinical predictors of response to lamotrigine and gabapentin monotherapy in refractory affective disorders. Author(s): Obrocea GV, Dunn RM, Frye MA, Ketter TA, Luckenbaugh DA, Leverich GS, Speer AM, Osuch EA, Jajodia K, Post RM. Source: Biological Psychiatry. 2002 February 1; 51(3): 253-60. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11839368&dopt=Abstract

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Comment on Rice ASC, Maton S, the Postherpetic Neuralgia Study Group (UK), gabapentin in postherpetic neuralgia: a randomized, double blind, placebo-controlled study. Author(s): Gehling M, Tryba M. Source: Pain. 2002 April; 96(3): 410-1. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11973022&dopt=Abstract

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Comment on Rice ASC, Maton S, the Postherpetic Neuralgia Study Group (UK), gabapentin in postherpetic neuralgia: a randomized, double blind, placebo-controlled study. Author(s): Bowsher D. Source: Pain. 2002 April; 96(3): 409-10; Author Reply 411-2. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11973021&dopt=Abstract

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Comment on: Serpell et al., gabapentin in neuropathic pain syndromes: a randomised double-blind, placebo controlled trial (Pain 2002; 99: 557-66). Author(s): McCleane GJ. Source: Pain. 2003 May; 103(1-2): 227; Author Reply 228. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12749981&dopt=Abstract

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Determination of gabapentin in plasma by liquid chromatography with fluorescence detection after solid-phase extraction with a C18 column. Author(s): Gauthier D, Gupta R. Source: Clinical Chemistry. 2002 December; 48(12): 2259-61. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12446488&dopt=Abstract

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Dosing to efficacy with neurontin: the STEPS trial. Study of Titration to Effect Profile of Safety. Author(s): Morrell MJ. Source: Epilepsia. 1999; 40 Suppl 6: S23-6; Discussion S73-4. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=10530679&dopt=Abstract

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Effect of gabapentin on nausea induced by chemotherapy in patients with breast cancer. Author(s): Guttuso T Jr, Roscoe J, Griggs J. Source: Lancet. 2003 May 17; 361(9370): 1703-5. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12767738&dopt=Abstract

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Effect of gabapentin on the anticonvulsant activity of antiepileptic drugs against electroconvulsions in mice: an isobolographic analysis. Author(s): Borowicz KK, Swiader M, Luszczki J, Czuczwar SJ. Source: Epilepsia. 2002 September; 43(9): 956-63. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12199720&dopt=Abstract

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Effectiveness of adjunctive gabapentin in resistant bipolar disorder: is it due to anxious-alcohol abuse comorbidity? Author(s): Perugi G, Toni C, Frare F, Ruffolo G, Moretti L, Torti C, Akiskal HS. Source: Journal of Clinical Psychopharmacology. 2002 December; 22(6): 584-91. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12454558&dopt=Abstract

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Effects of gabapentin and carbamazepine on the EEG and cognition in healthy volunteers. Author(s): Salinsky MC, Binder LM, Oken BS, Storzbach D, Aron CR, Dodrill CB. Source: Epilepsia. 2002 May; 43(5): 482-90. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12027908&dopt=Abstract

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Flumazenil and dialysis for gabapentin-induced coma. Author(s): Butler TC, Rosen RM, Wallace AL, Amsden GW. Source: The Annals of Pharmacotherapy. 2003 January; 37(1): 74-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12503937&dopt=Abstract

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Gabapentin -- a promising treatment in glossodynia. Author(s): Meiss F, Boerner D, Marsch WC, Fischer M. Source: Clinical and Experimental Dermatology. 2002 September; 27(6): 525-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12372102&dopt=Abstract

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Gabapentin (neuronetin) in the treatment of SUNCT syndrome. Author(s): Porta-Etessam J, Martinez-Salio A, Berbel A, Benito-Leon J. Source: Cephalalgia : an International Journal of Headache. 2002 April; 22(3): 249; Author Reply 249-50. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12047467&dopt=Abstract

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Gabapentin (Neurontin) as add-on therapy in patients with partial seizures: a doubleblind, placebo-controlled study. The International Gabapentin Study Group. Author(s): Anhut H, Ashman P, Feuerstein TJ, Sauermann W, Saunders M, Schmidt B. Source: Epilepsia. 1994 July-August; 35(4): 795-801. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=8082624&dopt=Abstract

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Gabapentin (NEURONTIN)--a novel anticonvulsant. Author(s): Murdoch LA. Source: Axone. 1994 December; 16(2): 56. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=7727298&dopt=Abstract

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Gabapentin (Neurontin, Parke-Davis). Author(s): Fisher K, McPherson ML. Source: Am J Hosp Palliat Care. 1997 November-December; 14(6): 311-2. Review. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=9392729&dopt=Abstract

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Gabapentin and lamotrigine in Indian patients of partial epilepsy refractory to carbamazepine. Author(s): Sethi A, Chandra D, Puri V, Mallika V. Source: Neurology India. 2002 September; 50(3): 359-63. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12391470&dopt=Abstract

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Gabapentin and lamotrigine: novel antiepileptic drugs. Author(s): Btaiche IF, Woster PS. Source: American Journal of Health-System Pharmacy : Ajhp : Official Journal of the American Society of Health-System Pharmacists. 1995 January 1; 52(1): 61-9. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12879525&dopt=Abstract

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Gabapentin and posttraumatic stress disorder. Author(s): Malek-Ahmadi P. Source: The Annals of Pharmacotherapy. 2003 May; 37(5): 664-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12708942&dopt=Abstract

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Gabapentin and PTSD. Author(s): Berigan TR. Source: The Journal of Clinical Psychiatry. 2002 August; 63(8): 744. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12197459&dopt=Abstract

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Gabapentin and vigabatrin increase GABA in the human neocortical slice. Author(s): Errante LD, Williamson A, Spencer DD, Petroff OA. Source: Epilepsy Research. 2002 May; 49(3): 203-10. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12076841&dopt=Abstract

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Gabapentin attenuates superior oblique myokymia. Author(s): Tomsak RL, Kosmorsky GS, Leigh RJ. Source: American Journal of Ophthalmology. 2002 May; 133(5): 721-3. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11992881&dopt=Abstract

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Gabapentin augmentation therapy in bipolar depression. Author(s): Wang PW, Santosa C, Schumacher M, Winsberg ME, Strong C, Ketter TA. Source: Bipolar Disorders. 2002 October; 4(5): 296-301. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12479661&dopt=Abstract

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Gabapentin dosing for neuropathic pain: evidence from randomized, placebocontrolled clinical trials. Author(s): Backonja M, Glanzman RL. Source: Clinical Therapeutics. 2003 January; 25(1): 81-104. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12637113&dopt=Abstract

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Gabapentin dosing in the treatment of epilepsy. Author(s): McLean MJ, Gidal BE. Source: Clinical Therapeutics. 2003 May; 25(5): 1382-406. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12867216&dopt=Abstract

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Gabapentin effect on neuropathic pain compared among patients with spinal cord injury and different durations of symptoms. Author(s): Ahn SH, Park HW, Lee BS, Moon HW, Jang SH, Sakong J, Bae JH. Source: Spine. 2003 February 15; 28(4): 341-6; Discussion 346-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12590206&dopt=Abstract

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Gabapentin for coeliac plexus pain. Author(s): Pelham A, Lee MA, Regnard CB. Source: Palliative Medicine. 2002 July; 16(4): 355-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12132549&dopt=Abstract

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Gabapentin for hot flashes in prostate cancer. Author(s): Jeffery SM, Pepe JJ, Popovich LM, Vitagliano G. Source: The Annals of Pharmacotherapy. 2002 March; 36(3): 433-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11895055&dopt=Abstract

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Gabapentin for neuropathic pain following spinal cord injury. Author(s): To TP, Lim TC, Hill ST, Frauman AG, Cooper N, Kirsa SW, Brown DJ. Source: Spinal Cord : the Official Journal of the International Medical Society of Paraplegia. 2002 June; 40(6): 282-5. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12037709&dopt=Abstract

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Gabapentin for relief of neuropathic pain related to anticancer treatment: a preliminary study. Author(s): Bosnjak S, Jelic S, Susnjar S, Luki V. Source: Journal of Chemotherapy (Florence, Italy). 2002 April; 14(2): 214-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12017380&dopt=Abstract

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Gabapentin for the management of hot flushes: a case series. Author(s): Albertazzi P, Bottazzi M, Purdie DW. Source: Menopause (New York, N.Y.). 2003 May-June; 10(3): 214-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12792292&dopt=Abstract

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Gabapentin for the treatment of ethanol withdrawal. Author(s): Voris J, Smith NL, Rao SM, Thorne DL, Flowers QJ. Source: Substance Abuse : Official Publication of the Association for Medical Education and Research in Substance Abuse. 2003 June; 24(2): 129-32. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12766380&dopt=Abstract

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Gabapentin for the treatment of familial erythromelalgia pain. Author(s): Pandey CK, Singh N, Singh PK. Source: J Assoc Physicians India. 2002 August; 50: 1094. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12421046&dopt=Abstract

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Gabapentin for the treatment of pain in guillain-barre syndrome: a double-blinded, placebo-controlled, crossover study. Author(s): Pandey CK, Bose N, Garg G, Singh N, Baronia A, Agarwal A, Singh PK, Singh U. Source: Anesthesia and Analgesia. 2002 December; 95(6): 1719-23, Table of Contents. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12456446&dopt=Abstract

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Gabapentin for the treatment of tremor. Author(s): Faulkner MA, Bertoni JM, Lenz TL. Source: The Annals of Pharmacotherapy. 2003 February; 37(2): 282-6. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12549962&dopt=Abstract

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Gabapentin in complicated school refusal. Author(s): Durkin JP 2nd. Source: Journal of the American Academy of Child and Adolescent Psychiatry. 2002 June; 41(6): 632-3. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12049438&dopt=Abstract

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Gabapentin in geriatric mania. Author(s): Sethi MA, Mehta R, Devanand DP. Source: Journal of Geriatric Psychiatry and Neurology. 2003 June; 16(2): 117-20. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12807075&dopt=Abstract

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Gabapentin in late-onset poststroke seizures. Author(s): Alvarez-Sabin J, Montaner J, Padro L, Molina CA, Rovira R, Codina A, Quintana M. Source: Neurology. 2002 December 24; 59(12): 1991-3. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12499501&dopt=Abstract

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Gabapentin in migraine prophylaxis: is it effective and well tolerated? Author(s): Schoonman GG, Wiendels NJ, Ferrari MD. Source: Headache. 2002 March; 42(3): 235. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11903552&dopt=Abstract

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Gabapentin in neuropathic pain syndromes: a randomised, double-blind, placebocontrolled trial. Author(s): Serpell MG; Neuropathic pain study group. Source: Pain. 2002 October; 99(3): 557-66. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12406532&dopt=Abstract

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Gabapentin in painful ophthalmoplegia. Author(s): Mercadante S. Source: Journal of Pain and Symptom Management. 2002 September; 24(3): 288-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12458108&dopt=Abstract

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Gabapentin in postamputation phantom limb pain: a randomized, double-blind, placebo-controlled, cross-over study. Author(s): Bone M, Critchley P, Buggy DJ. Source: Regional Anesthesia and Pain Medicine. 2002 September-October; 27(5): 481-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12373695&dopt=Abstract

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Gabapentin in the treatment of neuropathic pain after spinal cord injury: a prospective, randomized, double-blind, crossover trial. Author(s): Tai Q, Kirshblum S, Chen B, Millis S, Johnston M, DeLisa JA. Source: J Spinal Cord Med. 2002 Summer; 25(2): 100-5. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12137213&dopt=Abstract

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Gabapentin in the treatment of SUNCT syndrome. Author(s): Porta-Etessam J, Benito-Leon J, Martinez-Salio A, Berbel A. Source: Headache. 2002 June; 42(6): 523-4. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12167142&dopt=Abstract

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Gabapentin increases slow-wave sleep in normal adults. Author(s): Foldvary-Schaefer N, De Leon Sanchez I, Karafa M, Mascha E, Dinner D, Morris HH. Source: Epilepsia. 2002 December; 43(12): 1493-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12460250&dopt=Abstract

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Gabapentin induced cholestasis. Author(s): Richardson CE, Williams DW, Kingham JG. Source: Bmj (Clinical Research Ed.). 2002 September 21; 325(7365): 635. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12242176&dopt=Abstract

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Gabapentin suppresses cutaneous hyperalgesia following heat-capsaicin sensitization. Author(s): Dirks J, Petersen KL, Rowbotham MC, Dahl JB. Source: Anesthesiology. 2002 July; 97(1): 102-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12131110&dopt=Abstract

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Gabapentin therapy for amyotrophic lateral sclerosis: lack of improvement in neuronal integrity shown by MR spectroscopy. Author(s): Kalra S, Cashman NR, Caramanos Z, Genge A, Arnold DL. Source: Ajnr. American Journal of Neuroradiology. 2003 March; 24(3): 476-80. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12637300&dopt=Abstract

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Gabapentin toxicity requiring intubation in a patient receiving long-term hemodialysis. Author(s): Jones H, Aguila E, Farber HW. Source: Annals of Internal Medicine. 2002 July 2; 137(1): 74. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12093261&dopt=Abstract

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Gabapentin treatment of glossopharyngeal neuralgia: a follow-up of four years of a single case. Author(s): Moretti R, Torre P, Antonello RM, Bava A, Cazzato G. Source: European Journal of Pain (London, England). 2002; 6(5): 403-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12160515&dopt=Abstract

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Gabapentin treatment of impulsive-aggressive behaviour. Author(s): Biancosino B, Facchi A, Marmai L, Grassi L. Source: Canadian Journal of Psychiatry. Revue Canadienne De Psychiatrie. 2002 June; 47(5): 483-4. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12085684&dopt=Abstract

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Gabapentin treatment of multiple piloleiomyoma-related pain. Author(s): Alam M, Rabinowitz AD, Engler DE. Source: Journal of the American Academy of Dermatology. 2002 February; 46(2 Suppl Case Reports): S27-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11807464&dopt=Abstract

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Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. Author(s): Brodie MJ, Chadwick DW, Anhut H, Otte A, Messmer SL, Maton S, Sauermann W, Murray G, Garofalo EA; Gabapentin Study Group 945-212. Source: Epilepsia. 2002 September; 43(9): 993-1000. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12199724&dopt=Abstract

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Gabapentin withdrawal presenting as status epilepticus. Author(s): Barrueto F Jr, Green J, Howland MA, Hoffman RS, Nelson LS. Source: Journal of Toxicology. Clinical Toxicology. 2002; 40(7): 925-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12507063&dopt=Abstract

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Gabapentin. Author(s): Rosenquist RW. Source: J Am Acad Orthop Surg. 2002 May-June; 10(3): 153-6. Review. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12041936&dopt=Abstract

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Gabapentin. Pfizer. Author(s): Wheeler G. Source: Curr Opin Investig Drugs. 2002 March; 3(3): 470-7. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12054099&dopt=Abstract

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Gabapentin: pharmacology and its use in pain management. Author(s): Rose MA, Kam PC. Source: Anaesthesia. 2002 May; 57(5): 451-62. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11966555&dopt=Abstract

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Gabapentin: resistant neuropathic pain and malignancy. Author(s): Ross JR, Waight C, Riley J, Broadley K. Source: Palliative Medicine. 2001 July; 15(4): 348-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12054154&dopt=Abstract

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Gabapentin: the first preemptive anti-hyperalgesic for opioid withdrawal hyperalgesia? Author(s): Gustorff B, Kozek-Langenecker S, Kress HG. Source: Anesthesiology. 2003 June; 98(6): 1520-1; Author Reply 1521-2. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12766674&dopt=Abstract

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Gabapentin-induced anorgasmia in women. Author(s): Grant AC, Oh H. Source: The American Journal of Psychiatry. 2002 July; 159(7): 1247. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12091218&dopt=Abstract

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Gabapentin-induced bullous pemphigoid. Author(s): Zachariae CO. Source: Acta Dermato-Venereologica. 2002; 82(5): 396-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12430752&dopt=Abstract

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Gabapentin-induced paradoxical exacerbation of psychosis in a patient with schizophrenia. Author(s): Jablonowski K, Margolese HC, Chouinard G. Source: Canadian Journal of Psychiatry. Revue Canadienne De Psychiatrie. 2002 December; 47(10): 975-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12553139&dopt=Abstract

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High-performance liquid chromatographic method for the determination of gabapentin in human plasma. Author(s): Zhu Z, Neirinck L. Source: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences. 2002 November 5; 779(2): 307-12. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12361744&dopt=Abstract

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Hyperhidrosis in pediatric spinal cord injury: a case report and gabapentin therapy. Author(s): Adams BB, Vargus-Adams JN, Franz DN, Kinnett DG. Source: Journal of the American Academy of Dermatology. 2002 March; 46(3): 444-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11862186&dopt=Abstract

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Improvement of acquired pendular nystagmus by gabapentin: case report. Author(s): Fabre K, Smet-Dieleman H, Zeyen T. Source: Bull Soc Belge Ophtalmol. 2001; (282): 43-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12455139&dopt=Abstract

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Inhibition of neuronal Ca(2+) influx by gabapentin and pregabalin in the human neocortex. Author(s): Fink K, Dooley DJ, Meder WP, Suman-Chauhan N, Duffy S, Clusmann H, Gothert M. Source: Neuropharmacology. 2002 February; 42(2): 229-36. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11804619&dopt=Abstract

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Injury type-specific calcium channel alpha 2 delta-1 subunit up-regulation in rat neuropathic pain models correlates with antiallodynic effects of gabapentin. Author(s): Luo ZD, Calcutt NA, Higuera ES, Valder CR, Song YH, Svensson CI, Myers RR. Source: The Journal of Pharmacology and Experimental Therapeutics. 2002 December; 303(3): 1199-205. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12438544&dopt=Abstract

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Is gabapentin a “Broad-spectrum” analgesic? Author(s): Gilron I. Source: Anesthesiology. 2002 September; 97(3): 537-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12218517&dopt=Abstract

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Long-term use of gabapentin for treatment of pain after traumatic spinal cord injury. Author(s): Putzke JD, Richards JS, Kezar L, Hicken BL, Ness TJ. Source: The Clinical Journal of Pain. 2002 March-April; 18(2): 116-21. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11882775&dopt=Abstract

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Management of restless legs syndrome with gabapentin (Neurontin) Author(s): Mellick GA, Mellick LB. Source: Sleep. 1996 April; 19(3): 224-6. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=8723380&dopt=Abstract

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Massive gabapentin and presumptive quetiapine overdose. Author(s): Spiller HA, Dunaway MD, Cutino L. Source: Vet Hum Toxicol. 2002 August; 44(4): 243-4. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12136976&dopt=Abstract

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Mode of action of gabapentin in chronic neuropathic pain syndromes. A short review about its cellular mechanisms in nociceptive neurotransmission. Author(s): Surges R, Feuerstein TJ. Source: Arzneimittel-Forschung. 2002; 52(8): 583-6. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12236044&dopt=Abstract

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Modulation of cerebral GABA by topiramate, lamotrigine, and gabapentin in healthy adults. Author(s): Kuzniecky R, Ho S, Pan J, Martin R, Gilliam F, Faught E, Hetherington H. Source: Neurology. 2002 February 12; 58(3): 368-72. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11839834&dopt=Abstract

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Neurontin--1 year on. London October 1994. Author(s): Betts T. Source: Seizure : the Journal of the British Epilepsy Association. 1995 March; 4(1): 1-4. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=7788103&dopt=Abstract

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Oral gabapentin (neurontin) treatment of refractory genitourinary tract pain. Author(s): Sasaki K, Smith CP, Chuang YC, Lee JY, Kim JC, Chancellor MB. Source: Tech Urol. 2001 March; 7(1): 47-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11272678&dopt=Abstract

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Outcome evaluation of gabapentin as add-on therapy for partial seizures. “NEON” Study Investigators Group. Neurontin Evaluation of Outcomes in Neurological Practice. Author(s): Bruni J. Source: The Canadian Journal of Neurological Sciences. Le Journal Canadien Des Sciences Neurologiques. 1998 May; 25(2): 134-40. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=9604135&dopt=Abstract

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Pilot evaluation of gabapentin for treating hot flashes. Author(s): Loprinzi L, Barton DL, Sloan JA, Zahasky KM, Smith de AR, Pruthi S, Novotny PJ, Perez EA, Christensen BJ. Source: Mayo Clinic Proceedings. 2002 November; 77(11): 1159-63. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12440550&dopt=Abstract

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Plasma gabapentin concentrations in children with epilepsy: influence of age, relationship with dosage, and preliminary observations on correlation with clinical response. Author(s): Gatti G, Ferrari AR, Guerrini R, Bonanni P, Bonomi I, Perucca E. Source: Therapeutic Drug Monitoring. 2003 February; 25(1): 54-60. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12548145&dopt=Abstract

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Procedure for the monitoring of gabapentin with 2,4,6-trinitrobenzene sulfonic acid derivatization followed by HPLC with ultraviolet detection. Author(s): Juenke JM, Brown PI, McMillin GA, Urry FM. Source: Clinical Chemistry. 2003 July; 49(7): 1198-201. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12816924&dopt=Abstract

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Re: Lasso-de-la-Vega et al. gabapentin as a probable cause of hepatotoxicity and eosinophilia. Author(s): Hauben M. Source: The American Journal of Gastroenterology. 2002 August; 97(8): 2156-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12190207&dopt=Abstract

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Strictly unilateral headache reminiscent of hemicrania continua resistant to indomethacin but responsive to gabapentin. Author(s): Mariano Da Silva H, Alcantara MC, Bordini CA, Speciali JG. Source: Cephalalgia : an International Journal of Headache. 2002 June; 22(5): 409-10. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12110117&dopt=Abstract

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SUNCT responsive to gabapentin. Author(s): Hunt CH, Dodick DW, Bosch EP. Source: Headache. 2002 June; 42(6): 525-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12167143&dopt=Abstract

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SUNCT syndrome responsive to gabapentin (Neurontin). Author(s): Graff-Radford SB. Source: Cephalalgia : an International Journal of Headache. 2000 June; 20(5): 515-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11037748&dopt=Abstract

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The absorption of gabapentin following high dose escalation. Author(s): Berry DJ, Beran RG, Plunkeft MJ, Clarke LA, Hung WT. Source: Seizure : the Journal of the British Epilepsy Association. 2003 January; 12(1): 2836. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12495646&dopt=Abstract

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The analgesic effect of gabapentin and mexiletine after breast surgery for cancer. Author(s): Fassoulaki A, Patris K, Sarantopoulos C, Hogan Q. Source: Anesthesia and Analgesia. 2002 October; 95(4): 985-91, Table of Contents. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12351281&dopt=Abstract

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The anticonvulsant gabapentin (neurontin) does not act through gammaaminobutyric acid-B receptors. Author(s): Jensen AA, Mosbacher J, Elg S, Lingenhoehl K, Lohmann T, Johansen TN, Abrahamsen B, Mattsson JP, Lehmann A, Bettler B, Brauner-Osborne H. Source: Molecular Pharmacology. 2002 June; 61(6): 1377-84. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12021399&dopt=Abstract

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The use of gabapentin for the treatment of postherpetic neuralgia. Author(s): Singh D, Kennedy DH. Source: Clinical Therapeutics. 2003 March; 25(3): 852-89. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12852705&dopt=Abstract

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Three drug reviews: one reformulated and one new antifungal agent and optimal dosing of the anticonvulsant gabapentin. Author(s): Walson PD. Source: Clinical Therapeutics. 2003 May; 25(5): 1293-4. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12867213&dopt=Abstract

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Treatment of alcohol withdrawal with gabapentin. Author(s): Bozikas V, Petrikis P, Gamvrula K, Savvidou I, Karavatos A. Source: Progress in Neuro-Psychopharmacology & Biological Psychiatry. 2002 January; 26(1): 197-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11853112&dopt=Abstract

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Treatment of post-herpetic pain in myasthenia gravis: exacerbation of weakness due to gabapentin. Author(s): Scheschonka A, Beuche W. Source: Pain. 2003 July; 104(1-2): 423-4. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12855353&dopt=Abstract

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Treatment of restless legs syndrome with gabapentin: a double-blind, cross-over study. Author(s): Garcia-Borreguero D, Larrosa O, de la Llave Y, Verger K, Masramon X, Hernandez G. Source: Neurology. 2002 November 26; 59(10): 1573-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12451200&dopt=Abstract

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CHAPTER 2. NUTRITION AND NEURONTIN Overview In this chapter, we will show you how to find studies dedicated specifically to nutrition and Neurontin.

Finding Nutrition Studies on Neurontin The National Institutes of Health’s Office of Dietary Supplements (ODS) offers a searchable bibliographic database called the IBIDS (International Bibliographic Information on Dietary Supplements; National Institutes of Health, Building 31, Room 1B29, 31 Center Drive, MSC 2086, Bethesda, Maryland 20892-2086, Tel: 301-435-2920, Fax: 301-480-1845, E-mail: [email protected]). The IBIDS contains over 460,000 scientific citations and summaries about dietary supplements and nutrition as well as references to published international, scientific literature on dietary supplements such as vitamins, minerals, and botanicals.7 The IBIDS includes references and citations to both human and animal research studies. As a service of the ODS, access to the IBIDS database is available free of charge at the following Web address: http://ods.od.nih.gov/databases/ibids.html. After entering the search area, you have three choices: (1) IBIDS Consumer Database, (2) Full IBIDS Database, or (3) Peer Reviewed Citations Only. Now that you have selected a database, click on the “Advanced” tab. An advanced search allows you to retrieve up to 100 fully explained references in a comprehensive format. Type “Neurontin” (or synonyms) into the search box, and click “Go.” To narrow the search, you can also select the “Title” field.

7 Adapted from http://ods.od.nih.gov. IBIDS is produced by the Office of Dietary Supplements (ODS) at the National Institutes of Health to assist the public, healthcare providers, educators, and researchers in locating credible, scientific information on dietary supplements. IBIDS was developed and will be maintained through an interagency partnership with the Food and Nutrition Information Center of the National Agricultural Library, U.S. Department of Agriculture.

26 Neurontin

The following information is typical of that found when using the “Full IBIDS Database” to search for “Neurontin” (or a synonym): •

A randomized placebo-controlled comparative trial of gabapentin and propranolol in essential tremor. Author(s): Department of Neurology, Sant Pau Hospital, Autonomous University of Barcelona, Spain. Source: Gironell, A Kulisevsky, J Barbanoj, M Lopez Villegas, D Hernandez, G Pascual Sedano, B Arch-Neurol. 1999 April; 56(4): 475-80 0003-9942

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A summary of mechanistic hypotheses of gabapentin pharmacology. Author(s): Department of Neuroscience Therapeutics, Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Co., Ann Arbor, MI 48105, USA. Source: Taylor, C P Gee, N S Su, T Z Kocsis, J D Welty, D F Brown, J P Dooley, D J Boden, P Singh, L Epilepsy-Res. 1998 February; 29(3): 233-49 0920-1211

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AUStralian study of titration to effect profile of safety (AUS-STEPS): high-dose gabapentin (neurontin) in partial seizures. Author(s): Strategic Health Evaluators, Chatswood, Australia. Source: Beran, R Berkovic, S Black, A Danta, G Dunne, J Frasca, J Grainger, K Kilpatrick, C McKenzie, R McLaughlin, D Schapel, G Somerville, E Epilepsia. 2001 October; 42(10): 1335-9 0013-9580

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Characterization of the effects of gabapentin and 3-isobutyl-gamma-aminobutyric acid on substance P-induced thermal hyperalgesia. Author(s): Department of Anesthesiology, University of California, San Diego, La Jolla 92093-0818, USA. Source: Partridge, B J Chaplan, S R Sakamoto, E Yaksh, T L Anesthesiology. 1998 January; 88(1): 196-205 0003-3022

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Disposition of gabapentin (neurontin) in mice, rats, dogs, and monkeys. Author(s): Department of Pharmacokinetics and Drug Metabolism, Parke-Davis Pharmaceutical Research, Ann Arbor, MI 48105, USA. Source: Radulovic, L L Turck, D von Hodenberg, A Vollmer, K O McNally, W P DeHart, P D Hanson, B J Bockbrader, H N Chang, T Drug-Metab-Dispos. 1995 April; 23(4): 441-8 0090-9556

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Dosing to efficacy with neurontin: the STEPS trial. Study of Titration to Effect Profile of Safety. Author(s): Department of Neurology, Columbia University College of Physicians & Surgeons, New York, New York, USA. Source: Morrell, M J Epilepsia. 1999; 40 Suppl 6S23-6; discussion S73-4 0013-9580

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Effect of gabapentin (Neurontin) [corrected] on mood and well-being in patients with epilepsy. Author(s): CNS Clinical Research and Development, Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Company, Ann Arbor, MI, USA. Source: Dimond, K R Pande, A C Lamoreaux, L Pierce, M W ProgNeuropsychopharmacol-Biol-Psychiatry. 1996 April; 20(3): 407-17 0278-5846

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FDA approved new drug bulletin. Gabapentin (neurontin). Source: Anonymous RN. 1994 July; 57(7): 39-40 0033-7021

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Gabapentin (Neurontin) as add-on therapy in patients with partial seizures: a doubleblind, placebo-controlled study. The International Gabapentin Study Group. Author(s): Parke-Davis Pharmaceutical Research, Freiburg, Germany.

Nutrition 27

Source: Anhut, H Ashman, P Feuerstein, T J Sauermann, W Saunders, M Schmidt, B Epilepsia. 1994 Jul-August; 35(4): 795-801 0013-9580 •

Gabapentin (NEURONTIN)--a novel anticonvulsant. Source: Murdoch, L A Axone. 1994 December; 16(2): 56 0834-7824

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Gabapentin (Neurontin, Parke-Davis). Author(s): University of Maryland School of Pharmacy/Hospice Pharmacia, Baltimore, USA. Source: Fisher, K McPherson, M L Am-J-Hosp-Palliat-Care. 1997 Nov-December; 14(6): 311-2 1049-9091

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Gabapentin actions on N-methyl-D-aspartate receptor channels are protein kinase Cdependent. Author(s): Marine Biomedical Institute, University of Texas Medical Branch, Galveston, TX 77555-1069, USA. Source: Gu, Y Huang, L Y Pain. 2001 July; 93(1): 85-92 0304-3959

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Gabapentin as add-on therapy for refractory partial epilepsy: results of five placebocontrolled trials. Author(s): Parke-Davis Pharmaceutical Research, Division of the Warner-Lambert Company, Ann Arbor 48105. Source: Leiderman, D B Epilepsia. 1994; 35 Suppl 5S74-6 0013-9580

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Gabapentin in generalized seizures. Author(s): Department of Medical and Surgical Neurology, Walton Hospital, Liverpool, UK. Source: Chadwick, D Leiderman, D B Sauermann, W Alexander, J Garofalo, E EpilepsyRes. 1996 November; 25(3): 191-7 0920-1211

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Gabapentin inhibits high-threshold calcium channel currents in cultured rat dorsal root ganglion neurones. Author(s): Department of Biology, Pfizer Global R&D, Cambridge Laboratories, Cambridge, CB2 2QB. [email protected] Source: Sutton, K G Martin, D J Pinnock, R D Lee, K Scott, R H Br-J-Pharmacol. 2002 January; 135(1): 257-65 0007-1188

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Gabapentin is not a GABAB receptor agonist. Author(s): Neurology Centre of Excellence for Drug Discovery, GlaxoSmithKline, New Frontiers Science Park North, Third Avenue, Essex, CM19 5AW, Harlow, UK. Source: Lanneau, C Green, A Hirst, W D Wise, A Brown, J T Donnier, E Charles, K J Wood, M Davies, C H Pangalos, M N Neuropharmacology. 2001 December; 41(8): 96575 0028-3908

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Gabapentin, ineffective in normal rats, markedly reduces C-fibre evoked responses after inflammation. Author(s): Department of Pharmacology, University College London, UK. Source: Stanfa, L C Singh, L Williams, R G Dickenson, A H Neuroreport. 1997 February 10; 8(3): 587-90 0959-4965

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Gabapentin. CI 945, GOE 3450, Neurontin. Source: Anonymous Drugs-R-D. 1999 December; 2(6): 385-9 1174-5886

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Gabapentin: discussion. Author(s): Department of Neurology, University of Pittsburgh, School of Medicine, Pennsylvania 15261. Source: Fromm, G H Epilepsia. 1994; 35 Suppl 5S77-80 0013-9580

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Gabapentin--a new antiepileptic drug. Source: Anonymous Drug-Ther-Bull. 1994 April 21; 32(4): 29-30 0012-6543

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Gamma-aminobutyric acid type B receptors with specific heterodimer composition and postsynaptic actions in hippocampal neurons are targets of anticonvulsant gabapentin action. Author(s): Merck Frosst Center for Therapeutic Research, Kirkland, Canada. [email protected] Source: Ng, G Y Bertrand, S Sullivan, R Ethier, N Wang, J Yergey, J Belley, M Trimble, L Bateman, K Alder, L Smith, A McKernan, R Metters, K O'Neill, G P Lacaille, J C Hebert, T E Mol-Pharmacol. 2001 January; 59(1): 144-52 0026-895X

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Identification of novel ligands for the gabapentin binding site on the alpha2delta subunit of a calcium channel and their evaluation as anticonvulsant agents. Author(s): Parke Davis Neuroscience Research Centre, Cambridge University Forvie Site, Robinson Way, Cambridge CB2 2QB, U.K. Source: Bryans, J S Davies, N Gee, N S Dissanayake, V U Ratcliffe, G S Horwell, D C Kneen, C O Morrell, A I Oles, R J O'Toole, J C Perkins, G M Singh, L Suman Chauhan, N O'Neill, J A J-Med-Chem. 1998 May 21; 41(11): 1838-45 0022-2623

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Neurontin--1 year on. London October 1994. Author(s): Epilepsy Liaison Service and Seizure Clinic, Birmingham University, UK. Source: Betts, T Seizure. 1995 March; 4(1): 1-4 1059-1311

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Oral gabapentin (neurontin) treatment of refractory genitourinary tract pain. Author(s): Department of Urology, University of Pittsburgh School of Medicine, Pennsylvania, USA. Source: Sasaki, K Smith, C P Chuang, Y C Lee, J Y Kim, J C Chancellor, M B Tech-Urol. 2001 March; 7(1): 47-9 1079-3259

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Outcome evaluation of gabapentin as add-on therapy for partial seizures. “NEON” Study Investigators Group. Neurontin Evaluation of Outcomes in Neurological Practice. Author(s): Wellesly Hospital, Toronto, Ontario, Canada. Source: Bruni, J Can-J-Neurol-Sci. 1998 May; 25(2): 134-40 0317-1671

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Preferential action of gabapentin and pregabalin at P/Q-type voltage-sensitive calcium channels: inhibition of K+-evoked [3H]-norepinephrine release from rat neocortical slices. Author(s): Department of CNS Pharmacology, Pfizer Global Research & Development, Ann Arbor, Michigan 48105, USA. [email protected] Source: Dooley, D J Donovan, C M Meder, W P Whetzel, S Z Synapse. 2002 September 1; 45(3): 171-90 0887-4476

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Reflex sympathetic dystrophy treated with gabapentin. Author(s): American Pain Specialists, Inc., Elyria, OH 44035, USA. Source: Mellick, G A Mellick, L B Arch-Phys-Med-Rehabil. 1997 January; 78(1): 98-105 0003-9993

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Single-dose gabapentin pharmacokinetics and safety in healthy infants and children. Author(s): Department of Clinical Pharmacology, Parke-Davis Pharmaceutical Research Division of Warner-Lambert Company, Ann Arbor, Michigan 48105, USA. Source: Haig, G M Bockbrader, H N Wesche, D L Boellner, S W Ouellet, D Brown, R R Randinitis, E J Posvar, E L J-Clin-Pharmacol. 2001 May; 41(5): 507-14 0091-2700

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SUNCT syndrome responsive to gabapentin (Neurontin). Author(s): The Pain Center of Cedars-Sinai Medical Center and UCLA School of Dentistry, Los Angeles, CA, USA. Source: Graff Radford, S B Cephalalgia. 2000 June; 20(5): 515-7 0333-1024

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The anticonvulsant gabapentin (neurontin) does not act through gammaaminobutyric acid-B receptors. Author(s): NeuroScience PharmaBiotec Research Centre, Department of Medicinal Chemistry, the Royal Danish School of Pharmacy, Copenhagen, Denmark. Source: Jensen, Anders A Mosbacher, Johannes Elg, Susanne Lingenhoehl, Kurt Lohmann, Tania Johansen, Tommy N Abrahamsen, Bjarke Mattsson, January P Lehmann, Anders Bettler, Bernhard Brauner Osborne, Hans Mol-Pharmacol. 2002 June; 61(6): 1377-84 0026-895X

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The antiepileptic agent gabapentin (Neurontin) possesses anxiolytic-like and antinociceptive actions that are reversed by D-serine. Author(s): Department of Biology, Parke-Davis Neuroscience Research Center, Cambridge, UK. Source: Singh, L Field, M J Ferris, P Hunter, J C Oles, R J Williams, R G Woodruff, G N Psychopharmacology-(Berl). 1996 September; 127(1): 1-9 0033-3158

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The long-term safety and efficacy of gabapentin (Neurontin) as add-on therapy in drug-resistant partial epilepsy. The US Gabapentin Study Group. Source: Anonymous Epilepsy-Res. 1994 May; 18(1): 67-73 0920-1211

Federal Resources on Nutrition In addition to the IBIDS, the United States Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) provide many sources of information on general nutrition and health. Recommended resources include: •

healthfinder®, HHS’s gateway to health information, including diet and nutrition: http://www.healthfinder.gov/scripts/SearchContext.asp?topic=238&page=0

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The United States Department of Agriculture’s Web site dedicated to nutrition information: www.nutrition.gov

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The Food and Drug Administration’s Web site for federal food safety information: www.foodsafety.gov

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The National Action Plan on Overweight and Obesity sponsored by the United States Surgeon General: http://www.surgeongeneral.gov/topics/obesity/

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The Center for Food Safety and Applied Nutrition has an Internet site sponsored by the Food and Drug Administration and the Department of Health and Human Services: http://vm.cfsan.fda.gov/

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Center for Nutrition Policy and Promotion sponsored by the United States Department of Agriculture: http://www.usda.gov/cnpp/

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Food and Nutrition Information Center, National Agricultural Library sponsored by the United States Department of Agriculture: http://www.nal.usda.gov/fnic/

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Food and Nutrition Service sponsored by the United States Department of Agriculture: http://www.fns.usda.gov/fns/

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Additional Web Resources A number of additional Web sites offer encyclopedic information covering food and nutrition. The following is a representative sample: •

AOL: http://search.aol.com/cat.adp?id=174&layer=&from=subcats

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Family Village: http://www.familyvillage.wisc.edu/med_nutrition.html

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Google: http://directory.google.com/Top/Health/Nutrition/

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Healthnotes: http://www.healthnotes.com/

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Open Directory Project: http://dmoz.org/Health/Nutrition/

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Yahoo.com: http://dir.yahoo.com/Health/Nutrition/

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WebMDHealth: http://my.webmd.com/nutrition

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WholeHealthMD.com: http://www.wholehealthmd.com/reflib/0,1529,,00.html

The following is a specific Web list relating to Neurontin; please note that any particular subject below may indicate either a therapeutic use, or a contraindication (potential danger), and does not reflect an official recommendation (some Web sites are subscription based): •

Vitamins Folic Acid Source: Healthnotes, Inc. www.healthnotes.com Vitamin A Source: Healthnotes, Inc. www.healthnotes.com Vitamin B12 Source: Healthnotes, Inc. www.healthnotes.com Vitamin B6 Source: Healthnotes, Inc. www.healthnotes.com Vitamin D Source: Healthnotes, Inc. www.healthnotes.com Vitamin K Source: Healthnotes, Inc. www.healthnotes.com

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Minerals Biotin Source: Healthnotes, Inc. www.healthnotes.com Calcium Source: Healthnotes, Inc. www.healthnotes.com

Nutrition 31

Gabapentin Source: Healthnotes, Inc. www.healthnotes.com L-Carnitine Source: Healthnotes, Inc. www.healthnotes.com

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CHAPTER 3. ALTERNATIVE MEDICINE AND NEURONTIN Overview In this chapter, we will begin by introducing you to official information sources on complementary and alternative medicine (CAM) relating to Neurontin. At the conclusion of this chapter, we will provide additional sources.

National Center for Complementary and Alternative Medicine The National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (http://nccam.nih.gov/) has created a link to the National Library of Medicine’s databases to facilitate research for articles that specifically relate to Neurontin and complementary medicine. To search the database, go to the following Web site: http://www.nlm.nih.gov/nccam/camonpubmed.html. Select “CAM on PubMed.” Enter “Neurontin” (or synonyms) into the search box. Click “Go.” The following references provide information on particular aspects of complementary and alternative medicine that are related to Neurontin: •

A case of spinal cord injury-related pain with baseline rCBF brain SPECT imaging and beneficial response to gabapentin. Author(s): Ness TJ, San Pedro EC, Richards JS, Kezar L, Liu HG, Mountz JM. Source: Pain. 1998 November; 78(2): 139-43. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=9839825&dopt=Abstract

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Adjuvant therapy of melanoma with interferon-alpha-2b is associated with mania and bipolar syndromes. Author(s): Greenberg DB, Jonasch E, Gadd MA, Ryan BF, Everett JR, Sober AJ, Mihm MA, Tanabe KK, Ott M, Haluska FG. Source: Cancer. 2000 July 15; 89(2): 356-62. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=10918166&dopt=Abstract

•

Advances in the medical treatment of epilepsy. Author(s): Bazil CW, Pedley TA.

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Source: Annual Review of Medicine. 1998; 49: 135-62. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=9509255&dopt=Abstract •

An East-West approach to the management of central post-stroke pain. Author(s): Yen HL, Chan W. Source: Cerebrovascular Diseases (Basel, Switzerland). 2003; 16(1): 27-30. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12766358&dopt=Abstract

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Anti-allodynic action of the tormentic acid, a triterpene isolated from plant, against neuropathic and inflammatory persistent pain in mice. Author(s): Bortalanza LB, Ferreira J, Hess SC, Delle Monache F, Yunes RA, Calixto JB. Source: European Journal of Pharmacology. 2002 October 25; 453(2-3): 203-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12398905&dopt=Abstract

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Antiepileptic drug therapy. Author(s): Podell M. Source: Clin Tech Small Anim Pract. 1998 August; 13(3): 185-92. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=9775509&dopt=Abstract

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Antimyoclonic effect of gabapentin in a posthypoxic animal model of myoclonus. Author(s): Kanthasamy AG, Vu TQ, Yun RJ, Truong DD. Source: European Journal of Pharmacology. 1996 February 22; 297(3): 219-24. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=8666053&dopt=Abstract

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Determination of gabapentin in plasma by high-performance liquid chromatography. Author(s): Forrest G, Sills GJ, Leach JP, Brodie MJ. Source: Journal of Chromatography. B, Biomedical Applications. 1996 June 7; 681(2): 421-5. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=8811458&dopt=Abstract

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Felbamate, gabapentin and topiramate as adjuvant antiepileptic drugs in experimental models of epilepsy. Author(s): Czuczwar SJ, Przesmycki K. Source: Pol J Pharmacol. 2001 January-February; 53(1): 65-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11785915&dopt=Abstract

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Gabapentin as an adjuvant to opioid analgesia for neuropathic cancer pain. Author(s): Caraceni A, Zecca E, Martini C, De Conno F. Source: Journal of Pain and Symptom Management. 1999 June; 17(6): 441-5. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=10388250&dopt=Abstract

Alternative Medicine 35

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Gabapentin potentiates the antiseizure activity of certain anticonvulsants in DBA/2 mice. Author(s): De Sarro G, Spagnolo C, Gareri P, Gallelli L, De Sarro A. Source: European Journal of Pharmacology. 1998 May 22; 349(2-3): 179-85. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=9671096&dopt=Abstract

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Gabapentin, an adjuvant treatment for neuropathic pain in a cancer hospital. Author(s): Chandler A, Williams JE. Source: Journal of Pain and Symptom Management. 2000 August; 20(2): 82-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11032490&dopt=Abstract

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Management of spasticity, pain, and paroxysmal phenomena in multiple sclerosis. Author(s): Schapiro RT. Source: Curr Neurol Neurosci Rep. 2001 May; 1(3): 299-302. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11898533&dopt=Abstract

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Management of surgically hypogonadal patients unable to take sex hormone replacement therapy. Author(s): Nieman LK. Source: Endocrinology and Metabolism Clinics of North America. 2003 June; 32(2): 32536. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12800534&dopt=Abstract

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Myalgias and arthralgias associated with paclitaxel. Author(s): Garrison JA, McCune JS, Livingston RB, Linden HM, Gralow JR, Ellis GK, West HL. Source: Oncology (Huntingt). 2003 February; 17(2): 271-7; Discussion 281-2, 286-8. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12632867&dopt=Abstract

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Novel treatments for bipolar disorder. Author(s): Bowden CL. Source: Expert Opinion on Investigational Drugs. 2001 April; 10(4): 661-71. Review. Erratum In: Expert Opin Investig Drugs 2001 July; 10(7): Following 1205. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11281816&dopt=Abstract

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R3 nociceptive reflex in multiple sclerosis patients with paroxysmal symptoms treated with gabapentin. Author(s): D'Aleo G, Rifici C, Sessa E, Di Bella P, Bramanti P. Source: Funct Neurol. 2000 October-December; 15(4): 205-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11213523&dopt=Abstract

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Science reporters hear wide range of recent data at 12th annual conference. Author(s): Skolnick AA, Manack L. Source: Jama : the Journal of the American Medical Association. 1993 November 24; 270(20): 2413-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=8230606&dopt=Abstract

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Treatment of postherpetic neuralgia. Author(s): Menke JJ, Heins JR. Source: Journal of the American Pharmaceutical Association (Washington,D.C. : 1996). 1999 March-April; 39(2): 217-21. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=10079653&dopt=Abstract

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Use of gabapentin to treat taxane-induced myalgias. Author(s): van Deventer H, Bernard S. Source: Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology. 1999 January; 17(1): 434-5. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=10458265&dopt=Abstract

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Vincristine-induced allodynia in the rat. Author(s): Nozaki-Taguchi N, Chaplan SR, Higuera ES, Ajakwe RC, Yaksh TL. Source: Pain. 2001 July; 93(1): 69-76. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=11406340&dopt=Abstract

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What nonhormonal therapies are effective for postmenopausal vasomotor symptoms? Author(s): Brewer D, Nashelsky J. Source: The Journal of Family Practice. 2003 April; 52(4): 324-5, 329; Discussion 329. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ uids=12681094&dopt=Abstract

Additional Web Resources A number of additional Web sites offer encyclopedic information covering CAM and related topics. The following is a representative sample: •

Alternative Medicine Foundation, Inc.: http://www.herbmed.org/

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AOL: http://search.aol.com/cat.adp?id=169&layer=&from=subcats

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Chinese Medicine: http://www.newcenturynutrition.com/

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drkoop.com: http://www.drkoop.com/InteractiveMedicine/IndexC.html

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Family Village: http://www.familyvillage.wisc.edu/med_altn.htm

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Google: http://directory.google.com/Top/Health/Alternative/

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Healthnotes: http://www.healthnotes.com/

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MedWebPlus: http://medwebplus.com/subject/Alternative_and_Complementary_Medicine

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Open Directory Project: http://dmoz.org/Health/Alternative/

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HealthGate: http://www.tnp.com/

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WebMDHealth: http://my.webmd.com/drugs_and_herbs

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WholeHealthMD.com: http://www.wholehealthmd.com/reflib/0,1529,,00.html

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Yahoo.com: http://dir.yahoo.com/Health/Alternative_Medicine/

The following is a specific Web list relating to Neurontin; please note that any particular subject below may indicate either a therapeutic use, or a contraindication (potential danger), and does not reflect an official recommendation (some Web sites are subscription based): •

Herbs and Supplements Anticonvulsants Source: Healthnotes, Inc. www.healthnotes.com

General References A good place to find general background information on CAM is the National Library of Medicine. It has prepared within the MEDLINEplus system an information topic page dedicated to complementary and alternative medicine. To access this page, go to the MEDLINEplus site at http://www.nlm.nih.gov/medlineplus/alternativemedicine.html. This Web site provides a general overview of various topics and can lead to a number of general sources.

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CHAPTER 4. CLINICAL TRIALS AND NEURONTIN Overview In this chapter, we will show you how to keep informed of the latest clinical trials concerning Neurontin.

Recent Trials on Neurontin The following is a list of recent trials dedicated to Neurontin.8 Further information on a trial is available at the Web site indicated. •

Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal Condition(s): Alcoholism Study Status: This study is currently recruiting patients. Sponsor(s): National Institute on Alcohol Abuse and Alcoholism (NIAAA) Purpose - Excerpt: This study will evaluate a safe and useful medication for outpatient detoxification that is as effective as benzodiazepines in the short-term, and more effective in the protracted withdrawal period. gabapentin (Neurontin) will be compared to a standard benzodiazepine, lorazepam (Ativan), for its effectiveness in treating alcohol withdrawal. Phase(s): Phase II Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/show/NCT00011297

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Gabapentin For the Control of Hot Flashes in Women With Breast Cancer Condition(s): Anxiety Disorder; Breast Cancer; Depression; Hot Flashes; Quality of Life Study Status: This study is currently recruiting patients. Sponsor(s): James P. Wilmot Cancer Center; National Cancer Institute (NCI)

8

These are listed at www.ClinicalTrials.gov.

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Purpose - Excerpt: RATIONALE: gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes. PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer. Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/show/NCT00022074 •

Gabapentin in Fibromyalgia Trial (GIFT) Condition(s): Fibromyalgia Study Status: This study is currently recruiting patients. Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Purpose - Excerpt: This study will assess the safety and effectiveness of the drug gabapentin in reducing pain associated with primary fibromyalgia. Phase(s): Phase II; Phase III Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/show/NCT00057278

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Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer Condition(s): stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer; recurrent prostate cancer; Hot Flashes Study Status: This study is currently recruiting patients. Sponsor(s): North Central Cancer Treatment Group; National Cancer Institute (NCI) Purpose - Excerpt: RATIONALE: gabapentin may be effective in relieving hot flashes in men who have prostate cancer. It is not yet known which regimen of gabapentin is most effective in treating hot flashes. PURPOSE: Randomized phase III trial to compare different regimens of gabapentin in treating men who have prostate cancer. Phase(s): Phase III Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/show/NCT00028574

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Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy Condition(s): neurotoxicity; Pain; Quality of Life Study Status: This study is currently recruiting patients. Sponsor(s): North Central Cancer Treatment Group; National Cancer Institute (NCI) Purpose - Excerpt: RATIONALE: gabapentin may be effective in relieving pain and other symptoms of peripheral neuropathy. It is not yet known if gabapentin is effective in treating peripheral neuropathy in cancer patients undergoing chemotherapy. PURPOSE: Randomized phase III trial to determine the effectiveness of gabapentin in

Clinical Trials 41

treating pain and other symptoms of peripheral neuropathy in cancer patients undergoing chemotherapy. Phase(s): Phase III Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/show/NCT00027963 •

Gabapentin to treat itch in patients with liver disease Condition(s): Liver Disease; Cholestasis; Cirrhosis; Pruritus; Itching Study Status: This study is currently recruiting patients. Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Purpose - Excerpt: In this study, the effect of the medication gabapentin to treat itching secondary to liver disease is being studied. There are some funds to cover travel expenses for patients who are not from New York. gabapentin is approved to treat seizures in human beings. In this study, patients with liver disease who meet inclusion criteria are admitted to the research hospital of the New York Presbyterian Hospital to record scratching behavior by the use of a machine designed for that purpose. Blood work will be obtained. After completion of recording, patients are assigned by chance to receive active medication or placebo (a capsule that does not contain active medication). The patients will come to the outpatient office of the research hospital 2 weeks into the study for an interview and blood work. After 4 weeks, patients are readmitted to the hospital to record scratching behavior. After data are collected, the code is broken, if patient had been on inactive drug, active drug will be supplied as per protocol for 4 weeks. Blood work will be obtained. If patient had been randomized to active medication, the study will provide one week supply of drug. After that, the referring physician, with whom the study was previously discussed, could prescribe the medication as it is available. Phase(s): Phase III Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/show/NCT00058890

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Does gabapentin and lamotriginel have significantly fewer side-effects while providing equal or better seizure control than the current drug choice, carbamazepine, for the treatment of seizures in the elderly. Condition(s): seizures in the elderly Study Status: This study is no longer recruiting patients. Sponsor(s): Department of Veterans Affairs; Department of Veterans Affairs Cooperative Studies Program; Parke-Davis; Glaxo Wellcome Purpose - Excerpt: New onset epilepsy in the elderly occurs in 45,000-50,000 elderly patients each year. These patients are especially vulnerable to side effects from medications because of changes caused by the aging process and the fact that these patients often have many common diseases for which they are already receiving medications for so that the likelihood of drug interactions is increased. Two new drugs, gabapentin and lamotrigine, have recently been approved by the FDA as antiepileptic

42 Neurontin

drugs. These drugs have demonstrated efficacy in the treatment of partial onset seizures, the most common seizures in the elderly. These new compounds also have favorable side effect profiles and infrequent drug-drug interactions and, therefore, would be expected to be well-tolerated in the elderly. Phase(s): Phase III; MEDLINEplus consumer health information Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/show/NCT00007670 •

CREST-I: Resperine, Gabapentin, or Lamotrigine vs. Placebo - 7 Condition(s): Cocaine-Related Disorders Study Status: This study is completed. Sponsor(s): National Institute on Drug Abuse (NIDA) Purpose - Excerpt: A Modified Placebo-Controlled Study for the Treatment of Cocaine Dependence Using Reserpine, gabapentin, or Lamotrigine Versus an Unmatched Placebo Control Phase(s): Phase II Study Type: Observational Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/show/NCT00015106

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New Drugs in the Treatment of Mood Disorders Condition(s): Anxiety Disorder; Mood Disorder; Psychotic Disorder Study Status: This study is completed. Sponsor(s): National Institute of Mental Health (NIMH) Purpose - Excerpt: This clinical study compares the effectiveness of two anticonvulsants Lamotrigine (Lamictal) Monotherapy and gabapentin (Neurontin) in patients with treatment resistant affective disorders. We initially have found that the response rate to lamotrigine (51%) exceeded that of gabapentin (28%) or placebo (21%). In this study the placebo phase has been dropped so that we examine possible clinical and biological factors predictors of response. The drugs will be given in a randomized order for six weeks each and you will not know when you are on a given one. There will be a 2-4 week "washout" period between treatments. If you respond well to one of these treatments, a longer open continuation period will be offered at the end of this study. This would involve one or both drugs in combination. A variety of rating scales and brain imaging procedures will also be offered before and during each drug evaluation. Both lamotrigine and gabapentin are generally well tolerated. A serious potentially life threatening rash occurs in about 1/500 patients treated with lamotrigine, however. Common side effects are rash, dizziness, unsteadiness, double vision, blurred vision, nausea, vomiting, insomnia, sedation, and headache. These side effects are usually mild, and resolve with continued time on the drug or a decrease in dosage. Phase(s): Phase II Study Type: Interventional Contact(s): see Web site below

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Web Site: http://clinicaltrials.gov/ct/show/NCT00001482

Keeping Current on Clinical Trials The U.S. National Institutes of Health, through the National Library of Medicine, has developed ClinicalTrials.gov to provide current information about clinical research across the broadest number of diseases and conditions. The site was launched in February 2000 and currently contains approximately 5,700 clinical studies in over 59,000 locations worldwide, with most studies being conducted in the United States. ClinicalTrials.gov receives about 2 million hits per month and hosts approximately 5,400 visitors daily. To access this database, simply go to the Web site at http://www.clinicaltrials.gov/ and search by “Neurontin” (or synonyms). While ClinicalTrials.gov is the most comprehensive listing of NIH-supported clinical trials available, not all trials are in the database. The database is updated regularly, so clinical trials are continually being added. The following is a list of specialty databases affiliated with the National Institutes of Health that offer additional information on trials: •

For clinical studies at the Warren Grant Magnuson Clinical Center located in Bethesda, Maryland, visit their Web site: http://clinicalstudies.info.nih.gov/

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For clinical studies conducted at the Bayview Campus in Baltimore, Maryland, visit their Web site: http://www.jhbmc.jhu.edu/studies/index.html

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For cancer trials, visit the National Cancer Institute: http://cancertrials.nci.nih.gov/

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For eye-related trials, visit and search the Web page of the National Eye Institute: http://www.nei.nih.gov/neitrials/index.htm

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For heart, lung and blood trials, visit the Web page of the National Heart, Lung and Blood Institute: http://www.nhlbi.nih.gov/studies/index.htm

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For trials on aging, visit and search the Web site of the National Institute on Aging: http://www.grc.nia.nih.gov/studies/index.htm

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For rare diseases, visit and search the Web site sponsored by the Office of Rare Diseases: http://ord.aspensys.com/asp/resources/rsch_trials.asp

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For alcoholism, visit the National Institute on Alcohol Abuse and Alcoholism: http://www.niaaa.nih.gov/intramural/Web_dicbr_hp/particip.htm

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For trials on infectious, immune, and allergic diseases, visit the site of the National Institute of Allergy and Infectious Diseases: http://www.niaid.nih.gov/clintrials/

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For trials on arthritis, musculoskeletal and skin diseases, visit newly revised site of the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health: http://www.niams.nih.gov/hi/studies/index.htm

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For hearing-related trials, visit the National Institute on Deafness and Other Communication Disorders: http://www.nidcd.nih.gov/health/clinical/index.htm

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For trials on diseases of the digestive system and kidneys, and diabetes, visit the National Institute of Diabetes and Digestive and Kidney Diseases: http://www.niddk.nih.gov/patient/patient.htm

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For drug abuse trials, visit and search the Web site sponsored by the National Institute on Drug Abuse: http://www.nida.nih.gov/CTN/Index.htm

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For trials on mental disorders, visit and search the Web site of the National Institute of Mental Health: http://www.nimh.nih.gov/studies/index.cfm

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For trials on neurological disorders and stroke, visit and search the Web site sponsored by the National Institute of Neurological Disorders and Stroke of the NIH: http://www.ninds.nih.gov/funding/funding_opportunities.htm#Clinical_Trials

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CHAPTER 5. PATENTS ON NEURONTIN Overview Patents can be physical innovations (e.g. chemicals, pharmaceuticals, medical equipment) or processes (e.g. treatments or diagnostic procedures). The United States Patent and Trademark Office defines a patent as a grant of a property right to the inventor, issued by the Patent and Trademark Office.9 Patents, therefore, are intellectual property. For the United States, the term of a new patent is 20 years from the date when the patent application was filed. If the inventor wishes to receive economic benefits, it is likely that the invention will become commercially available within 20 years of the initial filing. It is important to understand, therefore, that an inventor’s patent does not indicate that a product or service is or will be commercially available. The patent implies only that the inventor has “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States. While this relates to U.S. patents, similar rules govern foreign patents. In this chapter, we show you how to locate information on patents and their inventors. If you find a patent that is particularly interesting to you, contact the inventor or the assignee for further information. IMPORTANT NOTE: When following the search strategy described below, you may discover non-medical patents that use the generic term “Neurontin” (or a synonym) in their titles. To accurately reflect the results that you might find while conducting research on Neurontin, we have not necessarily excluded nonmedical patents in this bibliography.

Patents on Neurontin By performing a patent search focusing on Neurontin, you can obtain information such as the title of the invention, the names of the inventor(s), the assignee(s) or the company that owns or controls the patent, a short abstract that summarizes the patent, and a few excerpts from the description of the patent. The abstract of a patent tends to be more technical in nature, while the description is often written for the public. Full patent descriptions contain much more information than is presented here (e.g. claims, references, figures, diagrams, etc.). We will tell you how to obtain this information later in the chapter. The following is an 9Adapted

from the United States Patent and Trademark Office: http://www.uspto.gov/web/offices/pac/doc/general/whatis.htm.

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example of the type of information that you can expect to obtain from a patent search on Neurontin: •

Combination of riluzole and of gabapentin and its use as a medicament Inventor(s): Bohme; Andrees (Paris, FR), Henderson; Christopher (Cassis, FR) Assignee(s): Aventis Pharma S.A. (Antony Cedex, FR) Patent Number: 6,350,768 Date filed: November 22, 2000 Abstract: The present invention relates to the combination of riluzole and of gabapentin or one of their pharmaceutically acceptable salts and its use as a medicament which is useful in particular for the prevention and/or treatment of motoneuron diseases. Excerpt(s): The present invention relates to the combination of riluzole and of gabapentin or one of their pharmaceutically acceptable salts and its use as a medicament which is useful in particular for the prevention and/or treatment of motoneuron diseases.... Motoneuron diseases include in particular amyotrophic lateral sclerosis, progressive spinal amyotrophy, infantile spinal amyotrophy and primary lateral sclerosis. They are caused by a progressive loss of motoneurons in the spinal cord.... Amyotrophic lateral sclerosis (ALS), also known by the name of CHARCOT's disease and LOU GEHRIG's disease, was described for the first time by CHARCOT in 1865. It is the most important motoneuron disease. ALS is a fatal disease resulting from degeneration of the motoneurons. The disease is accompanied by progressive paralysis, leading to the loss of motor and respiratory functions and then to death within a period of two to eight years after the appearance of the first symptoms. Web site: http://www.delphion.com/details?pn=US06350768__

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Gabapentin mohohydrate and a process for producing the same Inventor(s): Greenman; Barbara J. (Door, MI), Butler; Donald E. (Holland, MI) Assignee(s): Warner-Lambert Company (Morris Plains, NJ) Patent Number: 4,960,931 Date filed: October 6, 1989 Abstract: A novel crystalline form of gabapentin and a novel processes for the small and large scale preparations of the anticonvulsant compound in a highly pure state is disclosed. This novel hydrate is produced by a cost effective process which provides an additional purification stage. Excerpt(s): All examples of the syntheses end in an isocyanate or urethane that can easily be converted into the desired (1-aminomethyl)-1-cyclohexaneacetic acid by acidic hydrolysis (preferred) to give an acid or basic hydrolysis to give a basic salt or followed by acidification to give an acid salt.... The present invention provides crystalline gabapentin monohydrate, a novel, highly pure substance of reasonable bulk density suitable for formulation in the desired forms such as capsules or tablets. Its properties are those sought in a pharmaceutical product. The present invention provides both a small scale and a large scale method for producing gabapentin monohydrate. This form, the hydrate of the free amino acid, has the advantage of being less expensive to produce than the known form of gabapentin. The process has the advantage of having barely

Patents 47

detectable residues of solvents such as 2-propanol. No detectable methanol or ethanol residuals remain. Also, the process for producing the hydrate provides an extra purification step even if one goes on to produce the anhydrous material. The hydrate saves 12-13% of the total yield of gabapentin by eliminating the losses confronted in the final recrystallization. The hydrate also saves the cost of solvents, man hours, and utilities used in the final recrystallization The product is a very pretty crystal which is stable at ambient temperatures (20-25.degree. C.).... The instant invention is a novel form of gabapentin, crystalline gabapentin monohydrate with the following unique X-ray diffraction properties. Web site: http://www.delphion.com/details?pn=US04960931__ •

Gabapentin monohydrate and a process for producing the same Inventor(s): Greenman; Barbara J. (Door, MI), Butler; Donald E. (Holland, MI) Assignee(s): Warner-Lambert Company (Morris Plains, NJ) Patent Number: 4,894,476 Date filed: May 2, 1988 Abstract: A novel crystalline form of gabapentin and a novel processes for the small and large scale preparations of the anticonvulsant compound in a highly pure state is disclosed. This novel hydrate is produced by a cost effective process which provides an additional purification stage. Excerpt(s): All examples of the syntheses end in an isocyanate or urethane that can easily be converted into the desired (1-aminomethyl)-1-cyclohexaneacetic acid by acidic hydrolysis (preferred) to give an acid or basic hydrolysis to give a basic salt or followed by acidification to give an acid salt.... The present invention provides crystalline gabapentin monohydrate, a novel, highly pure substance of reasonable bulk density suitable for formulation in the desired forms such as capsules or tablets. Its properties are those sought in a pharmaceutical product. The present invention provides both a small scale and a large scale method for producing gabapentin monohydrate. This form, the hydrate of the free amino acid, has the advantage of being less expensive to produce than the known form of gabapentin. The process has the advantage of having barely detectable residues of solvents such as 2-propanol. No detectable methanol or ethanol residuals remain. Also, the process for producing the hydrate provides an extra purification step even if one goes on to produce the anhydrous material. The hydrate saves 12-13% of the total yield of gabapentin by eliminating the losses confronted in the final recrystallization. The hydrate also saves the cost of solvents, man hours, and utilities used in the final recrystallization. The product is a very pretty crystal which is stable at ambient temperatures (20.degree.-25.degree. C.).... The instant invention is a novel form of gabapentin, crystalline gabapentin monohydrate with the following unique X-ray diffraction properties. Web site: http://www.delphion.com/details?pn=US04894476__

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Pharmaceutical tablet formulation containing gabapentin with improved physical and chemical characteristics and method of making the same Inventor(s): Vilkov; Zalman (Dingman's Ferry, PA) Assignee(s): Purepac Pharmaceutical Co. (Elizabeth, NJ) Patent Number: 6,465,012 Date filed: June 6, 2001 Abstract: A pharmaceutical formulation form with improved physical and chemical characteristics, comprising gabapentin in tablet form for oral administration. The tablet form can be prepared by spray-coating gabapentin with a binder solution and compressing the spray-coated gabapentin into non-friable, stable tablets. This method is particularly useful for tablet formulations that require large doses of active drug. Excerpt(s): This invention is generally directed to pharmaceutical formulations with improved physical and chemical characteristics, comprising gabapentin in tablet form for oral administration. The tablet form can be prepared by spray-coating gabapentin with a binder solution and compressing the spray-coated gabapentin into non-friable, stable tablets. This invention is also generally directed to a method of producing pharmaceutical formulations in tablet form which contain large doses of active drug by spray-coating the active drug with a binder solution and compressing the spray-coated active drug into tablets.... Prior art methods for improving the compression characteristics of pharmaceutical formulations involve introducing additional excipients, such as microcrystalline cellulose, as compression aids to prevent fracturing of granules and tablets. However, the inclusion of additional excipients can be expensive and time consuming, can effect the stability of the active drug agent, and can increase the size of the tablet.... Other methods for improving the compression characteristics of pharmaceutical formulations include dissolving the active drug in a binder solution to form a drug solution, spray drying the drug solution to form a powder and then compressing the powder into a tablet. This method, however, is inefficient because it requires a large amount of binder solution. Moreover, dissolving the active drug in a solution can cause stability problems, polymorph conversion, and changes in the crystalline structure of the drug. Web site: http://www.delphion.com/details?pn=US06465012__

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Preparation of gabapentin Inventor(s): Singer; Claude (Kfar Saba, IL), Pesachovich; Michael (Givat Shmuel, IL), Pilarski; Gideon (Holon, IL) Assignee(s): Teva Pharmaceutical Industries Ltd. (Petah Tiqva, IL) Patent Number: 6,255,526 Date filed: June 22, 1999 Abstract: There is disclosed a method of converting gabapenting hydrochloride substantially free of inorganic salts to gabapenting form II. The method comprises the steps of: (1) obtaining gabapentin hydrochloride that is substantially free of inorganic salts; (2) mixing a solution of the gabapenting hydrochloride with an additional amine in a first solvent so as to obtain a precipitate comprising gabapenting; and then (3) recovering gabapentin form II from the precipitate. The precipitated gabapentin is a novel polymorphic form of gabapentin possessing a crystalline structure characterized

Patents 49

by novel sets of peaks in the powder X-ray diffraction pattern and in the FTIR spectra. This newly disclosed polymorph of gabapentin is characterized herein as gabapentin form III. The recovery step may comprise, for example, one of two alternative methods, slurrying the gabapentin form II in methanol, and then filtering the suspension to obtain gabapentin form II, or solubilizing the gabapentin form III in methanol with heating by reflux, and then cooling the solution to obtain gabapentin form II by crystallization. Excerpt(s): This invention relates to a new process for converting gabapentin hydrochloride salt to gabapentin via a novel polymorphic form of gabapentin.... Gabapentin is used in the treatment of cerebral diseases such as epilepsy. The literature describes many ways of preparing gabapentin from a variety of starting materials. U.S. Pat. No. 4,024,175 describes at least three methods of preparing gabapentin from cyclohexyl-1,1-diacetic acid. Each of these methods results in the formation of gabapentin hydrochloride salt, which may be converted to 1-(aminomethyl)-1cyclohexaneacetic acid by treatment with a basic ion exchanger and then crystallized from a solvent such as ethanol/ether.... U.S. Pat. No. 4,894,476 specifically discloses an improved method for converting the hydrochloride salt into the free amino acid. This involves pouring a deionized water solution of the salt over an ion exchange column, eluting with deionized water, producing a slurry from the eluate, adding an alcohol to the slurry, centrifuging and drying the slurry to obtain the free amino acid. Web site: http://www.delphion.com/details?pn=US06255526__ •

Process for producing gabapentin or pharmaceutical grade Inventor(s): Onrubia Miguel; Ma del Carmen (Barcelona, ES), Bosch Llado; Jordi (Girona, ES), Pagans Lista; Eugenia (Celra, ES) Assignee(s): Medichem, S.A. (Barcelona, ES) Patent Number: 6,528,682 Date filed: October 18, 2001 Abstract: The invention describes a process for the preparation of pharmaceutical grade gabapentin, consisting of neutralizing an alcoholic solution of gabapentin hydrochloride with basic ion exchange resins and thereafter directly isolating the gabapentin, without requiring either the formation or the isolation of intermediates other than the pharmaceutical grade product. Excerpt(s): The present invention relates to a process for the preparation of gabapentin suitable for pharmaceutical use by neutralization of alcoholic solutions of gabapentin hydrochloride with basic ion exchange resins.... The said compound has a therapeutical activity for convulsive type cerebral disorders, such as epilepsy, hypokinesia, including fainting, and other brain trauma and, in general, it is deemed to produce an improvement of the cerebral functions.... Gabapentin and several processes for the preparation thereof are described in Spanish patent ES-A-443 723, corresponding to U.S. Pat. No. 4,024,175, Example 1 of which describes the preparation of the free amino acid from the hydrochloride thereof, by treatment of an aqueous solution thereof with a basic ion exchanger, evaporation of the solvent and subsequent crystallization from a mixture of ethanol/ether. This process, which is only outlined without details in the said patents, has drawbacks for the industrial application thereof derived from having to evaporate large amounts of water, with the high energy consumption required thereby, and involving the use of a solvent such as ether, which is extremely dangerous and hard to handle on an industrial scale.

50 Neurontin

Web site: http://www.delphion.com/details?pn=US06528682__ •

Process for the preparation of gabapentin Inventor(s): Caraccia; Nicola (Novi Ligure, IT), Giordani; Cristiana (Novi Ligure, IT), Tenconi; Franco (Novi Ligure, IT) Assignee(s): Bioindustria Laboratorio Italiano Medicinali S.p.A. (Novi Ligure, IT) Patent Number: 6,576,790 Date filed: February 25, 2002 Abstract: A process for the preparation of gabapentin starting from gabapentin hydrochloride, which comprises the following steps: preparing a gabapentin hydrochloride aqueous solution; adjusting the pH of the solution to or about to gabapentin isoelectric point by addition of a basic compound comprising a monovalent anion; diafiltering the solution through a membrane highly selective for organic compounds with molecular weight higher than 150 and poorly selective for inorganic monovalent ions, to separate the solution into an aqueous permeate containing chloride ions and a retentate containing unsalified gabapentin substantially free from chloride ions; concentrating the retentate by increasing the pressure exerted on the membrane to obtain a concentration of unsalified gabapentin in the retentate not lower than 5%; evaporating the retentate under reduced pressure and at T.degree.