NCT02219932

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

A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects With Multiple Sclerosis (ENHANCE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 646 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	fampridine
DRUG	Placebo	Matched placebo

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-08-19
• Last updated: 2017-03-27
• Results posted: 2017-03-27

Locations

87 sites across 11 countries: United States, Bulgaria, Czechia, Finland, Italy, Lithuania, Netherlands, Poland, Russia, Serbia, United Kingdom