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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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Research Site
Ath, Belgium
Research Site
Bruges, Belgium
Research Site
Brussels, Belgium
Research Site
Leuven, Belgium
Research Site
Yvoir, Belgium
Research Site
Halifax, Nova Scotia, Canada
Research Site
London, Ontario, Canada
Research Site
Gatineau, Quebec, Canada
Research Site
Greenfield Park, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Start Date
August 1, 2012
Primary Completion Date
August 1, 2013
Completion Date
August 1, 2013
Last Updated
January 9, 2017
132
ACTUAL participants
BIIB041 (PR Fampridine)
DRUG
Placebo
OTHER
Lead Sponsor
Biogen
NCT06276634
NCT07225504
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06809192