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 (MOTION - JAPAN)

NCT01917019 Phase 3 COMPLETED

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.

Details

Lead sponsor	Biogen
Phase	Phase 3
Status	COMPLETED
Enrolment	101
Start date	2013-08
Completion	2017-03

Conditions

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

Interventions

• Placebo
• BIIB041 (fampridine)

Primary outcomes

• The proportion of participants who show a consistent improvement in walking speed — Part A (Up to 21 Weeks)
• Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — Part B (54 Weeks)

Countries

Japan