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)
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|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|
|Actual Primary Completion Date :||October 2012|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|