NCT01917019

A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis

A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Subjects With Multiple Sclerosis Followed by an Open-Label Safety Extension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter study conducted in 3 parts. Part A is a double-blind placebo-controlled parallel-group period, and Part B and C are open-label extension periods. The primary objective of the double-blind study (Part A) is to assess the effect of Prolonged-Release Fampridine treatment on walking speed as measured by the T25FW (timed 25 foot walk) in Japanese participants with Multiple Sclerosis. The secondary objective of the double-blind portion of the study is to evaluate the safety and tolerability of prolonged-release Fampridine in this study population. The primary objective of the open-label extension study (Part B) is to evaluate the long-term safety profile of prolonged-release Fampridine. The primary objective of the additional open-label extension (Part C) is to provide participants who complete the study with continued access to prolonged-release fampridine until marketed drug can be used at the applicable site or until sponsor decision to discontinue the study.

Conditions

• Multiple Sclerosis, Remittent Progressive
• Multiple Sclerosis, Primary Progressive
• Relapsing-Remitting Multiple Sclerosis
• Secondary Progressive Multiple Sclerosis
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Placebo	matching placebo tablets
DRUG	BIIB041 (fampridine)	fampridine prolonged-release tablets

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-10-01
• Completion: 2017-03-01
• First posted: 2013-08-06
• Last updated: 2017-03-21

Locations

19 sites across 1 country: Japan