Glatiramer Acetate Depot (Extended-Release) Phase IIa One-Year Study in Patients with Relapsing-Remitting Multiple Sclerosis: Safety, Tolerability and Efficacy (N... Conference Paper uri icon

abstract

  • The GA Depot small cohort one-year results support the assumption of its potential to improve MS treatment by significantly reducing number of injections, increasing adherence and providing a therapeutic benefit. GA Depot's safety, tolerability and encouraging efficacy data prompts the continuation to one phase III pivotal trial. Twenty-five RRMS patients were enrolled as follows: 80mg dose (n= 12) and 40mg dose (n= 13). Overall, 72% of study population were female, mean MS duration was 15.5±8.3 years and mean EDSS score was 2.4±1.6, at baseline. Adverse events (AEs) mainly included mild injection site reactions (ISRs) and no unexpected AEs were reported. Statistically significant fewer ISRs were reported with the 40mg dose than with the 80mg dose. No immediate post-injection reactions, as recorded with GA (Copaxone®), were detected. Two relapses were …

publication date

  • October 1, 2017