drugset / Trial / NCT02212886

Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS

NCT02212886

Phase 1/2 Completed 25 enrolled Mapi Pharma Ltd.
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

EvaluationDrugModalityDoseRoute
Subject Glatiramer Acetate Small molecule 40 mg Intramuscular
Subject Glatiramer Acetate Small molecule 80 mg Intramuscular

Indications