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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 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 1,404 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01067521
The ClinicalTrials.gov registry entry for NCT01067521 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,404 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01067521 reports 0 study locations.
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.
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