drugset / Trial / NCT03362294
Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a phase IIa study with GA Depot in subjects with Primary Progressive MS. GA Depot will be administered intramuscularly (IM), once every four weeks for 148 weeks. The purpose of this study is to assess the safety and efficacy of GA Depot to slow the accumulation of disability progression in subjects with Primary Progressive MS.
Timeline
- Start
- 2017-12-11
- Primary completion
- 2025-06-20
- Completion
- 2025-06-20
Outcome
Outcome not reported
Stopped: “The study was terminated early as part of a global realignment of Sponsor's clinical development programs. This decision is not related to any safety concerns regarding the IP.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glatiramer Acetate | Small molecule | 25 mg | Intramuscular |
| Subject | Glatiramer Acetate | Small molecule | 40 mg | Intramuscular |