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Immunomodulator

GA Depot for Multiple Sclerosis

Phase 3
Waitlist Available
Led By Aaron E. Miller, Prof. MD
Research Sponsored by Mapi Pharma Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study Summary

This trial is testing the efficacy of a long-acting injection of glatiramer acetate to treat relapsing forms of multiple sclerosis. The trial is double-blind, meaning neither the subjects nor the researchers will know who is receiving the active treatment or the placebo.

Eligible Conditions
  • Multiple Sclerosis, Relapsing-Remitting

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized Relapse Rate (ARR)
Secondary outcome measures
Changes in brain MRI (number of T1 lesions)
Changes in brain MRI (number of T2 lesions)
Enhancing T1-lesion volume change
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GA DepotExperimental Treatment1 Intervention
Monthly IM injection
Group II: PlaceboPlacebo Group1 Intervention
Monthly IM injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GA Depot
2019
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

Mapi Pharma Ltd.Lead Sponsor
2 Previous Clinical Trials
55 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
55 Patients Enrolled for Multiple Sclerosis
Aaron E. Miller, Prof. MDPrincipal InvestigatorMount Sinai School of Medicine, New York, US
Laura Popper, MDStudy DirectorMapi Pharma Ltd.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still enrolling people in this trial?

"This clinical trial, as reflected on clinicaltrials.gov, is no longer recruiting patients. It was initially posted on 9/19/2019 and last updated on 10/19/2022. However, there are 563 other trials currently looking for participants."

Answered by AI

How can I sign up for this clinical trial?

"Eligibility for this clinical trial is limited to patients with multiple sclerosis who are experiencing an acute relapse and are between 18-55 years old. Up to1016 people will be accepted into the study."

Answered by AI

Are there many locations in the United States where this research is being conducted?

"Patients are currently being enrolled at 12 different clinical trial sites, including Mapi Pharma Research site 01 in Northbrook, Illinois, Mapi Pharma Research site 11 in Cullman, Alabama, and Mapi Pharma Research site 12 in Washington D.C."

Answered by AI

Are patients who are 45 years or older being recruited for this study?

"The youngest age that this study permits is 18, while the oldest age is 55."

Answered by AI

Does GA Depot have the necessary regulatory approval for use in the United States?

"GA Depot is a Phase 3 trial drug, so its safety has been supported by some data and multiple rounds of testing."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
2019. "A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04121221.
~182 spots leftby Apr 2025
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