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Clinical Trial 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


Clinical Trial Description

A total of 1000 subjects are planned to be randomized into this study to receive treatment with GA Depot or with matching placebo. During the placebo controlled period (PC period, the first 52 weeks of the study immediately after randomization) subjects will receive either 40mg of GA Depot or matching placebo, IM, once every 4 weeks, for a total of 13 times. Subjects who complete the PC period of the study will be offered to continue into the open label period (OL period) for an additional 52 weeks, in which all subjects will receive 40mg of GA Depot IM once every 4 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04121221
Study type Interventional
Source Mapi Pharma Ltd.
Contact
Status Completed
Phase Phase 3
Start date September 19, 2019
Completion date June 13, 2023

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