Safety and Efficacy of Monthly Long-acting IM Injection of 40 mg GA Depot in Subjects With PPMS

Summary

Participation Requirements

Description

12 to 24 Subjects with a diagnosis of primary progressive multiple sclerosis (PPMS) who are not treated for PPMS at study entry (except for symptoms relief). Study product is GA long-acting injection (GA Depot) which is a combination of extended-release microspheres for injection and diluent (water ...

12 to 24 Subjects with a diagnosis of primary progressive multiple sclerosis (PPMS) who are not treated for PPMS at study entry (except for symptoms relief). Study product is GA long-acting injection (GA Depot) which is a combination of extended-release microspheres for injection and diluent (water for injection) for parenteral use. GA Depot will be administered intramuscularly (IM). The study duration for an individual subject in the core study will be 156 weeks, consisting of 4 weeks of screening evaluation (weeks -4 to 0), followed by a 148-week open-label treatment period, and a 4 weeks follow up period: through a total of 41 visits. Vital signs and safety assessment will be performed at each visit during the study. Physical examination will be performed at screening, baseline, 1 week after the second GA Depot treatment, 3 months after first GA Depot treatment and every 3 months thereafter. Last physical examination will be performed at FU visit. MRI will be performed at screenings and every 6 months thereafter until the end of the treatment period . Safety laboratory tests will be performed at screening, baseline, 1 month after first treatment, and every 3 months thereafter. Neurological assessment will be performed at screening, baseline, 3 months, and then every 3 months until end of treatment.

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