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Double-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple Sclerosis
To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.
Details
| Lead sponsor | Acorda Therapeutics |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 300 |
| Start date | 2005-05 |
| Completion | 2006-09 |
Conditions
- Multiple Sclerosis
Interventions
- Fampridine-SR
- Placebo
Primary outcomes
- Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk) — Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.
Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.
Countries
United States, Canada