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NCT01578785 · ClinicalTrials.gov registry record · Phase 3
An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Terminated
- Registry status
- Phase 3
- Development phase
- 178
- Enrollment target
NCT01578785: Clinical Trial Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01578785 is a Phase 3 study that was terminated before completion, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 178 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01578785, a Phase 3 study, was terminated before completion, sponsored by Teva Branded Pharmaceutical Products R&D.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 178 participants
- Enrollment target
Study Summary
This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).
Primary Outcome
The total number of confirmed relapses during the placebo-controlled phase is divided by the sum of the number of days on study in the placebo-controlled phase and then multiplied by the number of days in the year to calculate the annualized relapse rate.
Interventions
- DRUG Placebo
- DRUG Glatiramer Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2012-03 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
Why NCT01578785 stopped before completion
NCT01578785 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01578785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01578785 about?
NCT01578785 is a clinical study titled "An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)". This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).
What is the current status of trial NCT01578785?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 178 participants. The study started on 2012-03. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01578785?
The interventions under investigation include: Placebo (DRUG), Glatiramer Acetate (DRUG).
Who is sponsoring clinical trial NCT01578785?
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 NCT01578785's enrollment target sits among peer trials
178 1437th of 2000 higher than 563 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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