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A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS

NCT04121221 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1016

Last updated 2023-12-01

No results posted yet for this study

Summary

A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing Forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

GA Depot

Long acting intramuscular injection of glatiramer acetate, once every 4 weeks

OTHER

Placebo

IM injection once every 4 weeks

Sponsors & Collaborators

  • Mapi Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Laura Popper, MD · Mapi Pharma Ltd.

  • Aaron E. Miller, Prof. MD · Mount Sinai School of Medicine, New York, US

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-19
Primary Completion
2023-06-13
Completion
2023-06-13
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Bosnia and Herzegovina
  • Bulgaria
  • Estonia
  • Georgia
  • Israel
  • Moldova
  • Russia
  • Ukraine

Study Locations

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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 NCT04121221 on ClinicalTrials.gov