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NCT04121221 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Multiple Sclerosis (Relapsing Remitting), sponsored by Mapi Pharma.

Completed
Registry status
Phase 3
Development phase
1,016
Enrollment target
20
Study locations

NCT04121221 is a Phase 3 study of Multiple Sclerosis (Relapsing Remitting) that has completed, run by Mapi Pharma. The registered enrollment target is 1,016 participants, above the 528-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (92% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT04121221, a Phase 3 study of Multiple Sclerosis (Relapsing Remitting), has completed, sponsored by Mapi Pharma.

COMPLETED
Registry status
Phase 3
Development phase
1,016 participants
Enrollment target
20
Study locations

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 Studied

Multiple Sclerosis (Relapsing Remitting)

Interventions

  • OTHER Placebo
  • DRUG GA Depot

Study Locations (20)

Other

  • Mapi Pharma Research site 02 - Homyel
  • Mapi Pharma Research site 04 - Minsk
  • Mapi Pharma Research site 05 - Minsk
  • Mapi Pharma Research site 06 - Minsk
  • Mapi Pharma Research site 01 - Vitebsk
  • Mapi Pharma Research site 07 - Vitebsk
  • Mapi Pharma Research site 04 - Banja Luka
  • Mapi Pharma Research site 06 - Bihać
  • Mapi Pharma Research site 01 - Sarajevo

Alabama

  • Mapi Pharma Research site 08 - Birmingham
  • Mapi Pharma Research site 11 - Cullman

Florida

  • Mapi Pharma Research site 17 - Homestead
  • Mapi Pharma Research site 09 - Miami

California

  • Mapi Pharma Research site 15 - Pasadena

Colorado

  • Mapi Pharma Research site 14 - Denver

District of Columbia

  • Mapi Pharma Research site 12 - Washington D.C.

Illinois

  • Mapi Pharma Research site 01 - Northbrook

Michigan

  • Mapi Pharma Research site 02 - Detroit

Trial Details

FieldValue
Enrollment Target 1,016 participants
Start Date 2019-09-19
Est. Completion 2023-06-13
Phase Phase 3

Sponsor

Mapi Pharma

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04121221

The ClinicalTrials.gov registry entry for NCT04121221 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,016 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 528-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (92% higher). The listed sponsor is Mapi Pharma, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Sclerosis (Relapsing Remitting) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04121221 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, Alabama, Florida.

Frequently Asked Questions

What is clinical trial NCT04121221 about?

NCT04121221 is a clinical study titled "A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS". 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 ev...

What is the current status of trial NCT04121221?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,016 participants. The study started on 2019-09-19. Estimated completion is 2023-06-13.

What conditions does trial NCT04121221 study?

This clinical trial studies the following conditions: Multiple Sclerosis (Relapsing Remitting).

What interventions are being tested in trial NCT04121221?

The interventions under investigation include: Placebo (OTHER), GA Depot (DRUG).

Who is sponsoring clinical trial NCT04121221?

This trial is sponsored by Mapi Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04121221 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.