Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
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.