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NCT00654927 · 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
A Phase 3 study, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 177
- Enrollment target
NCT00654927: Completed Phase 3 study, sponsored by Acorda Therapeutics.
NCT00654927 is a Phase 3 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 177 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00654927, a Phase 3 study, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 177 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long-term safety, tolerability and activity of Fampridine-SR in subjects with multiple sclerosis who have previously participated in either an Acorda Therapeutics or an Elan Corporation sponsored protocol. Subjects are eligible regardless of whether they received active drug or placebo during their participation in the previous study.
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 b.i.d. (Twice Daily)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2003-11 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
What the finished NCT00654927 record still lists
NCT00654927 is an interventional study that assigns participants to a tested intervention. The registered 177 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 (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Fampridine-SR b.i.d. (Twice Daily) is the first listed.
NCT00654927 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00654927 about?
NCT00654927 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". The purpose of this study is to evaluate the long-term safety, tolerability and activity of Fampridine-SR in subjects with multiple sclerosis who have previously participated in either an Acorda Therapeutics or an Elan Corporation sponsored protocol. Subjects are eligible regardless of whether they ...
What is the current status of trial NCT00654927?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 177 participants. The study started on 2003-11. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00654927?
The interventions under investigation include: Fampridine-SR b.i.d. (Twice Daily) (DRUG).
Who is sponsoring clinical trial NCT00654927?
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 NCT00654927's enrollment target sits among peer trials
177 1438th of 2000 higher than 563 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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