Placebo-controlled trial of gabapentin in patients with amyotrophic lateral sclerosis

R. G. Miller, D. Moore, L. A. Young, C. Armon, R. J. Barohn, M. B. Bromberg, W. W. Bryan, D. F. Gelinas, M. C. Mendoza, H. E. Neville, G. J. Parry, J. H. Petajan, J. M. Ravits, S. P. Ringel, M. A. Ross

Research output: Contribution to journalArticlepeer-review

146 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1383-1388
Number of pages6
JournalNeurology
Volume47
Issue number6
DOIs
StatePublished - Dec 1996

ASJC Scopus subject areas

  • Clinical Neurology

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