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NCT01067521 · ClinicalTrials.gov registry record · Phase 3
A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,404
- Enrollment target
NCT01067521: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01067521 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 1,404 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01067521, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,404 participants
- Enrollment target
Study Summary
The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in subjects with RRMS, as measured by the number of confirmed relapses during the 12 month placebo controlled period. The study has two periods: * Placebo Controlled Period: 12 months of 40 mg administered three times a week by subcutaneous injection or matching placebo. * Open Label Extension Period: All subjects will continue treatment with GA 40 mg administered three times a week, until this dose strength is commercially available for the treatment of relapsing remitting multiple sclerosis (RRMS) patients or until the development of this GA dose regimen is stopped by the Sponsor
Primary Outcome
Relapses were monitored throughout the study. During the PC Period, two neurologists/physicians assessed subjects' general medical and neurological evaluations separately. A relapse was defined as the appearance of 1+ new neurological abnormalities or the reappearance of 1+ previously observed neurological abnormalities lasting \>= 48 hours and immediately preceded by an improving neurological state of at \>=30 days from onset of previous relapse. An event was counted as a relapse only when the
Interventions
- DRUG Placebo
- DRUG Glatiramer acetate (GA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,404 participants |
| Start Date | 2010-06-22 |
| Est. Completion | 2017-05-12 |
| Phase | Phase 3 |
What the finished NCT01067521 record still lists
NCT01067521 is an interventional study that assigns participants to a tested intervention. Its 1,404 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 (82% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01067521 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01067521 about?
NCT01067521 is a clinical study titled "A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo". The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in subjects with RRMS, as measured by the number of confirmed relapses during the 12 month placebo controlled period. The study has two periods: * Placebo Cont...
What is the current status of trial NCT01067521?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,404 participants. The study started on 2010-06-22. Estimated completion is 2017-05-12.
What interventions are being tested in trial NCT01067521?
The interventions under investigation include: Placebo (DRUG), Glatiramer acetate (GA) (DRUG).
Who is sponsoring clinical trial NCT01067521?
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 NCT01067521's enrollment target sits among peer trials
1,404 172nd of 2000 higher than 1,829 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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