drugset / Trial / NCT01597297

Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis.

NCT01597297

Phase 2 Completed 132 enrolled Biogen
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2012-08
Primary completion
2013-08
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalfampridine Small molecule 10 mg Oral

Indications