Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID
NCT02219932
Run by
Biogen
People needed
646
Starts
2014-09-01
Expected to finish
2016-02-01
Last updated by the study team
2017-03-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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