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ACTIVE NOT RECRUITING
NCT03362294
PHASE2

Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS

Sponsor: Mapi Pharma Ltd.

View on ClinicalTrials.gov

Summary

This is a phase IIa study with GA Depot in subjects with Primary Progressive MS. GA Depot will be administered intramuscularly (IM), once every four weeks for 148 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.

Official title: A Prospective, Multicenter, Two Arms, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 25 mg or 40mg Glatiramer Acetate (GA Depot) in Subjects With Primary Progressive Multiple Sclerosis (PPMS)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2017-12-11

Completion Date

2026-09

Last Updated

2024-12-05

Healthy Volunteers

No

Interventions

DRUG

GA Depot 40mg once monthly

Once-a-month long-acting intramuscular injection of 40mg Glatiramer Acetate (GA Depot)

DRUG

GA Depot 25mg once monthly

Once-a-month long-acting intramuscular injection of 25mg Glatiramer Acetate (GA Depot)

Locations (7)

Mapi Pharma Research site 09

Haifa, Israel

Mapi Pharma Research site 07

Jerusalem, Israel

Mapi Pharma Research site 08

Petah Tikva, Israel

Mapi Pharma Research site 06

Rehovot, Israel

Mapi Pharma Research site 01

Tel Aviv, Israel

Mapi Pharma Research site 20

Chisinau, Moldova

Mapi Pharma Research site 22

Chisinau, Moldova