NCT02212886

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

A Prospective 1-year, Open-label, Two Arms, Multicenter, Phase IIa Study to Assess Safety, Tolerability and Efficacy of Once a Month Long-acting Intramuscular Injection of 80 or 40 mg Glatiramer Acetate (GA Depot) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Mapi Pharma Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

* 25 Subjects with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who are treated with daily or thrice weekly subcutaneous injections of 20 mg or 40 mg respectively of GA (Copaxone®) during the previous 12 months * 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 60 weeks, consisting of 4 weeks of screening evaluation (weeks -4 to 0), followed by a 52-week open-label treatment period, and a 4 weeks follow up period: through a total of 17 visits. * For both arms, subjects who completed 13 injections and who consented (by signing an informed consent) are able to enter the optional 8 years extension period. During the extension period subjects will receive 40 mg of GA Depot IM once every 4 weeks. * Physical, vital signs and safety assessment - will be performed at each visit during the whole study. Physical examination will be performed quarterly during the extension period. * MRI at visit 1 (screenings), at week 24, week 52 (end of core study) and every 6 months during the extension period. * Neurological and safety laboratory tests at screening visit, on visits in weeks 4, 12, 24, 36, 52 (end of core study) and every 6 months during the extension period.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	GA Depot 80 mg	Recruitment completed
DRUG	GA Depot 40 mg	Recruitment completed

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-05-01
• Completion: 2024-11-20
• First posted: 2014-08-08
• Last updated: 2024-12-03

Locations

3 sites across 1 country: Israel