Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS
NCT03362294 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-04-23
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.
Conditions
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)
Sponsors & Collaborators
-
Mapi Pharma Ltd.
lead INDUSTRY
Principal Investigators
-
Arnon Karni, MD · Coordinating PI
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-11
- Primary Completion
- 2025-06-20
- Completion
- 2025-06-20
Countries
- Israel
- Moldova
Study Locations
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