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NCT02219932 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
A Phase 3 study of Multiple Sclerosis, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 646
- Enrollment target
- 20
- Study locations
NCT02219932: Completed Phase 3 study of Multiple Sclerosis, sponsored by Biogen.
NCT02219932 is a Phase 3 study of Multiple Sclerosis that has completed, run by Biogen. The registered enrollment target is 646 participants, above the 583-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (11% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02219932, a Phase 3 study of Multiple Sclerosis, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 646 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on participant-reported walking ability over a 24-week study period. The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical impact of multiple sclerosis (MS), and upper extremity function over a 24-week study period; to evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance; to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment period.
Primary Outcome
MSWS-12 is a participant self-assessment of the walking limitations due to MS during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where higher scores indicate greater impact on walking. A responder is defined as a participant with a mean improvement of at least 8 points over 24 weeks compared to baseline. Baseline is defined as the mean at Screening and Day 1 visit
Conditions Studied
Interventions
- DRUG Placebo
- DRUG fampridine
Study Locations (20)
Florida
- Research site - Bradenton
- Research Site - Orlando
- Research site - Tampa
- Research site - Tampa
- Research site - West Palm Beach
Other
- Research site - Pleven
- Research site - Plovdiv
- Research site - Sofia
North Carolina
- Research site - Charlotte
- Research site - Charlotte
Alabama
- Research site - Cullman
Arizona
- Research site - Phoenix
California
- Research site - San Diego
Kentucky
- Research site - Lexington
Massachusetts
- Research site - New Bedford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 646 participants |
| Start Date | 2014-09 |
| Est. Completion | 2016-02 |
| Phase | Phase 3 |
What the finished NCT02219932 record still lists
NCT02219932 is an interventional study that assigns participants to a tested intervention. The registered 646 participants enrollment target is mid-sized for trials with a published cap, above the 583-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (11% higher).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02219932 names 20 study sites across 13 states, led by Florida, Other, North Carolina.
Frequently Asked Questions
What is clinical trial NCT02219932 about?
NCT02219932 is a clinical study titled "Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis". The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on participant-reported walking ability over a 24-week study period. The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken twice da...
What is the current status of trial NCT02219932?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 646 participants. The study started on 2014-09. Estimated completion is 2016-02.
What conditions does trial NCT02219932 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT02219932?
The interventions under investigation include: Placebo (DRUG), fampridine (DRUG).
Who is sponsoring clinical trial NCT02219932?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02219932 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02219932's enrollment target sits among peer trials
646 39th of 315 higher than 277 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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