NCT01578785

An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

A Multinational, Multicenter, Randomized, Parallel Group, Double Blind, Placebo Controlled Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate 20mg/0.5ml New Formulation Administered Daily by Subcutaneous Injection

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).

Detailed description

Approximately 1400 participants were planned for this study, however only 178 were enrolled prior to early termination.

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Glatiramer Acetate	Glatiramer acetate 20mg in 0.5ml for subcutaneous injection in a pre-filled syringe (PFS) is administered daily. Each PFS also contains 20mg mannitol dissolved in water for injection.
DRUG	Placebo	Matching placebo injection; 20 mg mannitol dissolved in 0.5 mL water for subcutaneous injection in a PFS is administered daily.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2012-04-17
• Last updated: 2014-04-02
• Results posted: 2014-04-02

Locations

169 sites across 19 countries: United States, Albania, Belarus, Bosnia and Herzegovina, Bulgaria, Croatia, Estonia, Georgia, Greece, Latvia, Mexico, Moldova, Montenegro, North Macedonia, Poland, Romania, Russia, Serbia, Ukraine