Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis. (MOBILE)
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|ClinicalTrials.gov Identifier: NCT01597297|
Recruitment Status : Completed
First Posted : May 14, 2012
Last Update Posted : January 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: BIIB041 (PR Fampridine) Other: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Prolonged-Release Fampridine (Fampridine-PR) 10 mg twice daily (every 12 hours) for up to 24 weeks.
Drug: BIIB041 (PR Fampridine)
10 mg twice daily, given orally. Doses of study treatment must be spaced at least 12 hours apart. If a dose of study treatment is delayed or missed, the participant should not dose again until their next scheduled dose. Tablets must be swallowed whole and should be taken without food.
Placebo Comparator: Placebo
Matched placebo twice daily (every 12 hours) for up to 24 weeks.
Twice daily, given orally. Doses of study treatment must be spaced at least 12 hours apart. If a dose of study treatment is delayed or missed, the participant should not dose again until their next scheduled dose. Tablets must be swallowed whole and should be taken without food.
- Change from baseline in self-assessed walking disability as reported on the Multiple Sclerosis Walking Scale-12 (MSWS-12) [ Time Frame: Day 1, up to 24 weeks ]
- Change from baseline in static balance as assessed by Berg Balance Scale (BBS) [ Time Frame: Day 1, up to 24 weeks ]
- Change from baseline in dynamic balance as assessed by the Timed Up and Go (TUG) scale) [ Time Frame: Day 1, up to 24 weeks ]
- Change from baseline in subjective impression of well-being measured by Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: Day 1, up to 24 weeks ]
- Change from baseline in subjective impression of well-being measured by Euro Quality of Life-5D (EQ-5D) [ Time Frame: Day 1, up to 24 weeks ]
- Participant's global impression of change in walking as reported on the Patient Global Impression of Change Scale (PGIC) [ Time Frame: Day 1, up to 24 weeks ]
- Summary of Participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Day 1 Up to 26 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597297
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada|
|London, Ontario, Canada|
|Gatineau, Quebec, Canada|
|Greenfield Park, Quebec, Canada|
|Montreal, Quebec, Canada|
|Ancona, AN, Italy|
|Brescia, BS, Italy|
|Empoli, FI, Italy|
|Palermo, PA, Italy|
|Roma, RM, Italy|
|Edgbaston, Birmingham, United Kingdom|
|Poole, Dorset, United Kingdom|
|Swansea, Glamorgan, United Kingdom|
|London, United Kingdom|
|Study Director:||Medical Director||Biogen|