Glatiramer Acetate Depot
US Patent number 8,377,885 granted: Depot Systems Comprising Glatiramer or Pharmacologically Acceptable Salt Thereof
Relapsing Multiple Sclerosis (RMS) Studies
Phase III: A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects with RMS
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
ClinicalTrials.gov Identifier: NCT04121221
Phase II: Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects with RRMS
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
ClinicalTrials.gov Identifier: NCT02212886
Primary Progressive Multiple Sclerosis (PPMS) Studies
Phase II: Safety and Efficacy of Monthly Long-acting IM Injection of 40 mg GA Depot in Subjects with PPMS
This is a phase IIa study with GA Depot in subjects with Primary Progressive MS. GA Depot is administered intramuscularly (IM), once every four weeks for 100 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.
ClinicalTrials.gov Identifier: NCT03362294