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 Volume 56, Number 7, April 10, 2001
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Neurology 2001;56:843-848
© 2001 American Academy of Neurology
Articles

Phase III randomized trial of gabapentin in patients with amyotrophic lateral sclerosis

R. G. Miller, MD;, D. H. Moore, II, PhD;, D. F. Gelinas, MD;, V. Dronsky, MD;, M. Mendoza, RT;, R. J. Barohn, MD;, W. Bryan, MD;, J. Ravits, MD;, E. Yuen, MD;, H. Neville, MD;, S. Ringel, MD;, M. Bromberg, MD;, J. Petajan, MD;, A. A. Amato, MD;, C. Jackson, MD;, W. Johnson, MD;, R. Mandler, MD;, P. Bosch, MD;, B. Smith, MD;, M. Graves, MD;, M. Ross, MD;, E. J. Sorenson, MD;, P. Kelkar, MD;, G. Parry, MD;, R. Olney, MD and and the WALS Study Group

*See the Appendix on page 847 for a complete list of the members of the Western ALS Study Group.
From the Department of Neurology (Drs. Miller, Moore, Gelinas, Dronsky, and M. Mendoza), California Pacific Medical Center, San Francisco; Department of Neurology (Drs. Barohn and Bryan), University of Texas Southwest Medical School, Dallas; Department of Neurology (Drs. Ravits and Yuen), Virginia Mason Medical Center, Seattle, WA; Department of Neurology (Drs. Neville and Ringel), University of Colorado School of Medicine, Denver; Department of Neurology (Dr. Neville), Denver Veterans Affairs Medical Center, CO; Department of Neurology (Drs. Bromberg and Petajan), University of Utah, SR210 Medical Center, Salt Lake City; Department of Neurology (Drs. Amato and Jackson), University of Texas Health Science Center, San Antonio; Department of Neurology (Dr. Johnson), Oregon Health Sciences University, Portland; Department of Neurology (Dr. Mandler), University of New Mexico School of Medicine, Albuquerque; Department of Neurology (Drs. Bosch and Smith), Mayo Clinic Scottsdale, AZ; Department of Neurology (Dr. Graves), UCLA School of Medicine, Los Angeles, CA; Department of Neurology (Dr. Ross), University of Kentucky College of Medicine, Lexington; Departments of Neurology (Dr. Sorenson), Mayo Clinic Rochester, MN; Department of Neurology (Dr. Parry), University of Minnesota, Minneapolis; and Departments of Neurology (Dr. Olney) and Biostatistics (Dr. Moore), University of California, San Francisco.

Address correspondence and reprint requests to Dr. Robert G. Miller, Department of Neurology, California Pacific Medical Center, 2324 Sacramento Street #150, San Francisco, CA 94115; e-mail: rmiller{at}cooper.cpmc.org

BACKGROUND: Preclinical and clinical studies of gabapentin in patients with ALS led the authors to undertake a phase III randomized clinical trial.

METHODS: Patients were randomly assigned, in a double-blinded fashion, to receive oral gabapentin 3,600 mg or placebo daily for 9 months. The primary outcome measure was the average rate of decline in isometric arm muscle strength for those with two or more evaluations.

RESULTS: Two hundred four patients enrolled, 196 had two or more evaluations, and 128 patients completed the study. The mean rate of decline of the arm muscle strength was not significantly different between the groups. Moreover, there was no beneficial effect upon the rate of decline of other secondary measures (vital capacity, survival, ALS functional rating scale, timed walking) nor was there any symptomatic benefit. In fact, analysis of the combined data from the phase II and III trials revealed a significantly more rapid decline of forced vital capacity in patients treated with gabapentin.

CONCLUSION: These data provide no evidence of a beneficial effect of gabapentin on disease progression or symptoms in patients with ALS.




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