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

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

ARR during the 52 weeks of the PC period as derived from the total number of confirmed relapses

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
Mapi Pharma

1 total trials

What the finished NCT04121221 record still lists

NCT04121221 is an interventional study that assigns participants to a tested intervention. Its 1,016 participants enrollment target places it among the larger protocols in the corpus, above the 528-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (92% higher).

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 names 20 study sites across 10 states, led by 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.

Similar trials for Multiple Sclerosis (Relapsing Remitting)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04121221's enrollment target sits among peer trials

1,016 3rd of 29 higher than 27 of 29 other Multiple Sclerosis (Relapsing Remitting) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple Sclerosis (Relapsing Remitting) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04121221, the US trial registry maintained by the National Library of Medicine. NCT04121221 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.