Multiple Sclerosis Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects With Multiple Sclerosis
The objectives of this study in Multiple Sclerosis (MS) participants treated with prolonged-released fampridine (BIIB041) 10 mg twice daily compared with participants treated with placebo are to assess the effect over 24 weeks on the following parameters to explore endpoints for the Phase 3 study: self-assessed walking disability, dynamic and static balance, subjective impression of well-being, and participants' global impression of change in walking . Another purpose of this study is to evaluate the safety and tolerability of prolonged-release fampridine.
The primary objective of the study is to explore the effect of prolonged-released fampridine
10 mg twice daily in patients with Multiple Sclerosis with walking disability. The change of
walking ability will be measured using Multiple Sclerosis Walking Scale-12 (MSWS-12) to
further elucidate the clinical relevance of changes over 24 weeks treatment duration.
Another purpose of this study is to evaluate the safety and tolerability of
prolonged-release fampridine.
Approximately 120 patients MS will be randomized over 20 sites worldwide. Duration of
patient's participation in the study will be approximately 28 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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