drugset / Trial / NCT02212886
Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS
Non-randomizedParallel-groupOpen-labelTreatment
Summary
* This is a phase IIa study in which GA Depot 80 or 40mg is administered as an IM injection to subjects with RRMS at 4 week intervals for 52 weeks of treatment. * The purpose of the study is to assess safety, tolerability, and efficacy of a monthly long-acting IM injection of 80 or 40mg GA Depot in subjects with RRMS. The study will include subjects switching from daily or thrice weekly administration of 20 mg or 40mg respectively of glatiramer acetate (GA, i.e., Copaxone®) injection
Timeline
- Start
- 2014-10
- Primary completion
- 2017-05
- Completion
- 2024-11-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glatiramer Acetate | Small molecule | 40 mg | Intramuscular |
| Subject | Glatiramer Acetate | Small molecule | 80 mg | Intramuscular |