A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis
Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
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.