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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02219932
The ClinicalTrials.gov registry entry for NCT02219932 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 646 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 583-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (11% higher). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.