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NCT00649792 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial
A Phase 3 study, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 214
- Enrollment target
NCT00649792: Completed Phase 3 study, sponsored by Acorda Therapeutics.
NCT00649792 is a Phase 3 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 214 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00649792, a Phase 3 study, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 214 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months in patients who previously participated in the MS-F204 study or until it becomes commercially available, whichever comes first.
Primary Outcome
All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.
Interventions
- DRUG Fampridine-SR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2007-08 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
What the finished NCT00649792 record still lists
NCT00649792 is an interventional study that assigns participants to a tested intervention. The registered 214 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 (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Fampridine-SR is the first listed.
NCT00649792 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00649792 about?
NCT00649792 is a clinical study titled "Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial". The purpose of the study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months in patients who previously participated in the MS-F204 study or until it becomes commercially available, whichever comes first.
What is the current status of trial NCT00649792?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 214 participants. The study started on 2007-08. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00649792?
The interventions under investigation include: Fampridine-SR (DRUG).
Who is sponsoring clinical trial NCT00649792?
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 NCT00649792's enrollment target sits among peer trials
214 1335th of 2000 higher than 666 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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