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NCT01281189 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Dexpramipexole in ALS
A Phase 3 study, sponsored by Knopp Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 942
- Enrollment target
NCT01281189: Completed Phase 3 study, sponsored by Knopp Biosciences.
NCT01281189 is a Phase 3 study that has completed, run by Knopp Biosciences. The registered enrollment target is 942 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01281189, a Phase 3 study, has completed, sponsored by Knopp Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 942 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).
Primary Outcome
The Composite Assessment of Function and Survival (CAFS) is a between-group comparison of a single ranked clinical outcome based on (1) the change from baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) score and (2) time to death. Each subject is ranked according to time-to-death (earlier deaths ranked lower than later deaths). Subjects who survive are ranked more favorably than subjects who died. Among the survivors, subjects are ranked according to change in ALSFRS-R (greater worsenin
Interventions
- DRUG Placebo
- DRUG Dexpramipexole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 942 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01281189 record still lists
NCT01281189 is an interventional study that assigns participants to a tested intervention. The registered 942 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01281189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01281189 about?
NCT01281189 is a clinical study titled "Phase 3 Study of Dexpramipexole in ALS". The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).
What is the current status of trial NCT01281189?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 942 participants. The study started on 2011-03. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01281189?
The interventions under investigation include: Placebo (DRUG), Dexpramipexole (DRUG).
Who is sponsoring clinical trial NCT01281189?
This trial is sponsored by Knopp Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01281189's enrollment target sits among peer trials
942 335th of 2000 higher than 1,664 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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