A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
| Condition | Multiple Sclerosis, Relapsing-Remitting |
|---|---|
| Phase | Phase 3 |
| Sponsor | Mapi Pharma Ltd. |
| Status | Completed |
| Enrollment | 1,016 participants |
| Interventions | GA Depot |
| Start date | Sep 19, 2019 |
| Completion date | Jun 13, 2023 |
| Results posted | Aug 5, 2026 |
Summary
A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing Forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks
Annualized Relapse Rate (ARR)
| Early Start: GA Depot 40 mg | 0.182 ± 0.022 Relapses per participant per year |
|---|---|
| Delayed Start: Placebo | 0.260 ± 0.029 Relapses per participant per year |
Open in BENITIONS View on ClinicalTrials.gov
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