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news.Acorda Therapeutics has begun a second phase III clinical study of Fampridine-SR in multiple sclerosis, with the randomization of its first patient into the treatment phase of the study.
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The study is expected to enroll approximately 200 patients at 35 leading multiple sclerosis (MS) clinical centers in the US and Canada. Fifteen centers have been initiated and are in the process of screening subjects for the trial.
The study will evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS. An SPA is a process in which the FDA provides guidance on a phase III clinical trial whose data will form the primary basis for an efficacy claim. Pending clinical results from MS-F204, the FDA has agreed that this study together with the previous phase III study would be adequate to support a new drug application for Fampridine-SR, according to the company.
The primary outcome measure for the study will be a walking response criterion, defined as a consistent improvement in walking speed as measured by the Timed 25-Foot Walk. The secondary outcome measure for this study is the Lower Extremity Manual Muscle Test.