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NCT00605215 · ClinicalTrials.gov registry record · Phase 3
BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®)
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,331
- Enrollment target
NCT00605215: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT00605215 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 1,331 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00605215, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,331 participants
- Enrollment target
Study Summary
The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 milligrams (mg) with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing Multiple Sclerosis (MS) injectable drug: Interferon β-1a (Avonex®).
Primary Outcome
A relapse was defined as the appearance of new neurological abnormalities or the reappearance of previously observed neurological abnormalities; lasting at least 48 hours and immediately preceded by an improved neurological state of ≥30 days from onset of previous relapse, accompanied by observed objective neurological changes (an increase of ≥0.5 in Expanded Disability Status Scale \[EDSS\] score, or an increase of 1 grade in the score of 2 or more of the 7 Functional Systems \[FS\], or an incr
Interventions
- DRUG Placebo
- DRUG Laquinimod
- DRUG Avonex®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,331 participants |
| Start Date | 2008-04-24 |
| Est. Completion | 2011-06-10 |
| Phase | Phase 3 |
What the finished NCT00605215 record still lists
NCT00605215 is an interventional study that assigns participants to a tested intervention. Its 1,331 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00605215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00605215 about?
NCT00605215 is a clinical study titled "BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®)". The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 milligrams (mg) with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing Multiple Sclerosis (MS) injectable drug: Interferon β-1a (Avonex®).
What is the current status of trial NCT00605215?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,331 participants. The study started on 2008-04-24. Estimated completion is 2011-06-10.
What interventions are being tested in trial NCT00605215?
The interventions under investigation include: Placebo (DRUG), Laquinimod (DRUG), Avonex® (DRUG).
Who is sponsoring clinical trial NCT00605215?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00605215's enrollment target sits among peer trials
1,331 183rd of 2000 higher than 1,818 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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