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Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
NCT02219932 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 646 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02219932 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Other, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02219932?
The interventions under investigation include: Placebo (DRUG), fampridine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02219932?
This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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