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NCT00647296 · ClinicalTrials.gov registry record · Phase 2
Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study, sponsored by Knopp Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 194
- Enrollment target
NCT00647296: Completed Phase 2 study, sponsored by Knopp Biosciences.
NCT00647296 is a Phase 2 study that has completed, run by Knopp Biosciences. The registered enrollment target is 194 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00647296, a Phase 2 study, has completed, sponsored by Knopp Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 194 participants
- Enrollment target
Study Summary
This was a 2-part study of dexpramipexole in patients with ALS. Part 1 was a randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, and clinical effects of oral administration of 3 dosage levels of dexpramipexole vs. placebo for 12 weeks. Part 2 was a randomized, double-blind, 2-arm, parallel group, extension study evaluating the safety, tolerability, and clinical effects of oral administration of 2 dosage levels of dexpramipexole for up to 72 weeks.
Primary Outcome
Number of Participants with Potentially Clinically Significant Hematology Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.
Interventions
- DRUG Placebo
- DRUG Dexpramipexole 50 mg/day
- DRUG Dexpramipexole 150 mg/day
- DRUG Dexpramipexole 300 mg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2008-04-09 |
| Est. Completion | 2009-09-04 |
| Phase | Phase 2 |
What the finished NCT00647296 record still lists
NCT00647296 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00647296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00647296 about?
NCT00647296 is a clinical study titled "Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS)". This was a 2-part study of dexpramipexole in patients with ALS. Part 1 was a randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, and clinical effects of oral administration of 3 dosage levels of dexpramipexole vs. placebo for 12 weeks. Part 2 was a randomized, ...
What is the current status of trial NCT00647296?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 194 participants. The study started on 2008-04-09. Estimated completion is 2009-09-04.
What interventions are being tested in trial NCT00647296?
The interventions under investigation include: Placebo (DRUG), Dexpramipexole 50 mg/day (DRUG), Dexpramipexole 150 mg/day (DRUG), Dexpramipexole 300 mg/day (DRUG).
Who is sponsoring clinical trial NCT00647296?
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 NCT00647296's enrollment target sits among peer trials
194 352nd of 2000 higher than 1,649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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