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Fampridine-SR in multiple sclerosis: a randomized, double-blind, placebo-controlled, dose-ranging studyDepartment of Neurology, University of Rochester, Rochester, NY 14642, USA,andrew_goodman@u rmc.rochester.edu
Department of Neurology, Mellen Center, Cleveland Clinic Foundation, Cleveland, OH 44195, USA
Department of Neurology, Washington University, St Louis, MO 63110, USA
Department of Neurology, Yale University, New Haven, CT 06520, USA
Department of Neurology, Yale University, New Haven, CT 06520, USA
Acorda Therapeutics, Inc., Hawthorne, NY 10532, USA
Acorda Therapeutics, Inc., Hawthorne, NY 10532, USA
Acorda Therapeutics, Inc., Hawthorne, NY 10532, USA Objective To determine the safety of sustained-release 4-aminopyridine in subjects with mutiple sclerosis (MS) and to examine dose-related efficacy up to 40 mg twice daily. Method Multicenter, randomized, double-blind, placebo-controlled, study. Following a 4-week baseline peroid, subjects were randomly assigned to receive Fampridine-SR (n=25, doses from 10 to 40 mg twice daily, increasing in 5 mg increments weekly) or placebo (n=11). A battery of assessments was performed weekly, including the MS Functional Composite (MSFC), fatigue questionnaires, and lower extremity manual muscle testing. Results The most common adverse events were dizziness, insomnia, paresthesia, asthenia, nausea, headache, and tremor. Five subjects were discontinued from Fampridine-SR because of adverse events at doses greater than 25 mg, and these included convulsions in two subjects at doses of 30 and 35 mg twice daily. Improvement were seen in lower extremity muscle strength (prospective analysis) and walking speed (post-hoc analysis) in the Fampridine-SR group compared to placebo (unadjusted p-values of 0.01 and 0.03, respectively). There were no significant differences in other MSFC measure or fatigue scores. Conclusions Future studies should employ doses up to 20 mg twice daily with lower extremity strength and walking speed as potential outcome measures. Multiple Sclerosis 2007; 13: 357-368. http://msj.sagepub.com
Key Words: 4-aminopyridine • clinical trial • Fampridine-SR • multiple sclerosis • safety
This version was published on April
1, 2007 Multiple Sclerosis, Vol. 13, No. 3,
357-368 (2007) This article has been cited by other articles:
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