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) (GLOW)
|ClinicalTrials.gov Identifier: NCT01578785|
Recruitment Status : Terminated
First Posted : April 17, 2012
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Relapsing-Remitting Multiple Sclerosis||Drug: Glatiramer Acetate Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||178 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||March 2012|
|Primary Completion Date :||October 2012|
|Study Completion Date :||November 2012|
Experimental: Glatiramer Acetate
Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
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.
Other Name: Copaxone®
Placebo Comparator: Placebo
Placebo solution in prefilled syringe for subcutaneous injection once daily.
Matching placebo injection; 20 mg mannitol dissolved in 0.5 mL water for subcutaneous injection in a PFS is administered daily.
- The Annualized Relapse Rate During the Placebo Controlled Period [ Time Frame: Day 1 up to Month 12 ]The total number of confirmed relapses during the placebo-controlled phase is divided by the sum of the number of days on study in the placebo-controlled phase and then multiplied by the number of days in the year to calculate the annualized relapse rate.
- The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period) [ Time Frame: Day 1 up to Month 12 ]Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions.
- The Cumulative Number of Gadolinium-enhancing Lesions on T1-weighted Images Measured at Months 6 and 12 (End of Placebo Controlled Period) [ Time Frame: Day 1 up to Month 12 ]Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.
- Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume [ Time Frame: Day 1 up to Month 12 ]Brain atrophy was defined by the percent brain volume change from baseline to Month 12
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578785
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|Principal Investigator:||Alexey Boyko, MD||Department of Neurology, Russian State Medical University|