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NCT01006265 · ClinicalTrials.gov registry record · Phase 2
Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis
A Phase 2 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 2
- Development phase
- 464
- Enrollment target
NCT01006265: Completed Phase 2 study, sponsored by Actelion.
NCT01006265 is a Phase 2 study that has completed, run by Actelion. The registered enrollment target is 464 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (249% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01006265, a Phase 2 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 464 participants
- Enrollment target
Study Summary
This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.
Primary Outcome
Cumulative Number of new T1 gadolinium-enhancing (Gd+) lesions per year on magnetic resonance imaging (MRI) scan from Week 12 to Week 24 were reported. Negative binomial (NB) regression analysis on Per protocol analysis set and imputation was applied for the missing data. Here, MS signifies multiple sclerosis.
Interventions
- DRUG Placebo
- DRUG ACT-128800 Dose 1
- DRUG ACT-128800 Dose 2
- DRUG ACT-128800 Dose 3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 464 participants |
| Start Date | 2009-10-01 |
| Est. Completion | 2011-07-01 |
| Phase | Phase 2 |
What the finished NCT01006265 record still lists
NCT01006265 is an interventional study that assigns participants to a tested intervention. The registered 464 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 (249% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01006265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01006265 about?
NCT01006265 is a clinical study titled "Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis". This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.
What is the current status of trial NCT01006265?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 464 participants. The study started on 2009-10-01. Estimated completion is 2011-07-01.
What interventions are being tested in trial NCT01006265?
The interventions under investigation include: Placebo (DRUG), ACT-128800 Dose 1 (DRUG), ACT-128800 Dose 2 (DRUG), ACT-128800 Dose 3 (DRUG).
Who is sponsoring clinical trial NCT01006265?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01006265's enrollment target sits among peer trials
464 81st of 2000 higher than 1,919 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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