Drug Development
Biotech company initiates phase III trial of Fampridine-SR in multiple sclerosis
Published in Medical Letter on the CDC and FDA, August 7th, 2005
The study, which is based on a Special Protocol Assessment (SPA) issued by the Food and Drug Administration (FDA), will evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS.
The primary outcome measure for the study will be an improvement in walking ability; secondary outcomes will include measurements of leg strength and muscle spasticity. The studies will enroll a total of 240 patients at approximately 30 of the leading MS clinical centers in the United States and...
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