Conditions: Multiple Sclerosis
Keywords: Fampridine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 646
Healthy volunteers: no

Brief summary:
The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on participant-reported walking ability over a 24-week study period.

The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical impact of multiple sclerosis (MS), and upper extremity function over a 24-week study period; to evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance; to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment period.

Detailed description:

Arms:
arm 1: Prolonged-release fampridine 10 mg twice daily (BID) for up to 24 weeks arm 2: Matched placebo 10 mg BID for up to 24 weeks

Interventions: intervention 1: fampridine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Matched placebo

Protocol document: