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NCT01328379 · ClinicalTrials.gov registry record · Phase 3
Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis
A Phase 3 study, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 430
- Enrollment target
NCT01328379: Completed Phase 3 study, sponsored by Acorda Therapeutics.
NCT01328379 is a Phase 3 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 430 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01328379, a Phase 3 study, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 430 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the safety and efficacy of a lower dose of dalfampridine extended release tablets compared to the currently approved dose in improving walking in Multiple Sclerosis (MS) patients.
Primary Outcome
The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient's physical disability. A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient's foot crosses the tape. Timing will end when any part of the patient's foot crosses the finish line (identified by a taped mark o
Interventions
- OTHER Placebo
- DRUG Dalfampridine-ER 5mg
- DRUG Dalfampridine-ER 10mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
What the finished NCT01328379 record still lists
NCT01328379 is an interventional study that assigns participants to a tested intervention. The registered 430 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01328379 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01328379 about?
NCT01328379 is a clinical study titled "Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis". The purpose of this study is to investigate the safety and efficacy of a lower dose of dalfampridine extended release tablets compared to the currently approved dose in improving walking in Multiple Sclerosis (MS) patients.
What is the current status of trial NCT01328379?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 430 participants. The study started on 2011-03. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01328379?
The interventions under investigation include: Placebo (OTHER), Dalfampridine-ER 5mg (DRUG), Dalfampridine-ER 10mg (DRUG).
Who is sponsoring clinical trial NCT01328379?
This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01328379's enrollment target sits among peer trials
430 877th of 2000 higher than 1,123 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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