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

NCT02212886 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-12-03

No results posted yet for this study

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

Conditions

Interventions

DRUG

GA Depot 80 mg

Recruitment completed

DRUG

GA Depot 40 mg

Recruitment completed

Sponsors & Collaborators

  • Mapi Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Shlomo Flechter, M.D

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-05-31
Completion
2024-11-20

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02212886 on ClinicalTrials.gov