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NCT00648908 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial
A Phase 3 study, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 269
- Enrollment target
NCT00648908: Completed Phase 3 study, sponsored by Acorda Therapeutics.
NCT00648908 is a Phase 3 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 269 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00648908, a Phase 3 study, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 269 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months, or until it becomes commercially available whichever comes first, in subjects who previously participated in Acorda Therapeutics Protocol MS-F203.
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 | 269 participants |
| Start Date | 2006-06 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
What the finished NCT00648908 record still lists
NCT00648908 is an interventional study that assigns participants to a tested intervention. The registered 269 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 (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Fampridine-SR is the first listed.
NCT00648908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00648908 about?
NCT00648908 is a clinical study titled "Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial". The purpose of this study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months, or until it becomes commercially available whichever comes first, in subjects who previously participated in Acorda Therapeutics Protocol MS-F203.
What is the current status of trial NCT00648908?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 269 participants. The study started on 2006-06. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00648908?
The interventions under investigation include: Fampridine-SR (DRUG).
Who is sponsoring clinical trial NCT00648908?
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 NCT00648908's enrollment target sits among peer trials
269 1220th of 2000 higher than 779 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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