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The WALS Study Group.*
*For the Study Group participants, see the end of the article.
From the Departments of Neurology at California Pacific Medical Center (Drs. Miller, Moore, and Gelinas, and L. A. Young and M. C. Mendoza), Loma Linda University School of Medicine (Dr. Armon), The University of Colorado School of Medicine (Drs. Bromberg, Neville, Petajan, and Ringel), the Denver Veteran Affairs Medical Center (Dr. Neville), the Universities of Iowa (Dr. Ross), Minnesota (Dr. Parry), Texas-SW Medical School (Drs. Barohn and Bryan), Utah (Drs. Bromberg, Neville, Petajan, and Ringel), and the Virginia Mason Medical Center (Dr. Ravits), Seattle.
Supported by Parke-Davis. The investigators received no financial incentives such as equity interest, patent rights, or corporate affiliation. Compensation was provided only for some of the costs of the study and not for reimbursement of investigator time in carrying out the trial.
Presented in part at the 48th annual meeting of the American Academy of Neurology, San Francisco, March 1996.
Received April 10, 1996. Accepted in final form May 20, 1996.
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.
We designed a phase II trial to evaluate the efficacy of gabapentin in slowing the rate of decline in muscle strength of patients with amyotrophic lateral sclerosis (ALS) and to assess safety and tolerability.Gabapentin (800 mg) or placebo was administered t.i.d. in a randomized, double-blinded, placebo-controlled, trial for 6 months. We enrolled 152 patients at eight sites in the United States. The primary outcome measure was the slope of the arm megascore, the average maximum voluntary isometric strength from eight arm muscles standardized against a reference ALS population. A secondary outcome measure was forced vital capacity. Slopes of arm megascores for patients on gabapentin were compared with slopes of those taking placebo using a two-way ANOVA. We observed a nonstatistically significant trend (p = 0.057-0.08) toward slower decline of arm strength in patients taking gabapentin compared with those taking placebo (mean difference 24%, median 37%). We observed no treatment effect on forced vital capacity. Gabapentin was well tolerated by patients with ALS. These results suggest that further studies of gabapentin in ALS are warranted.
NEUROLOGY 1996;47: 1383-1388
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