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).
Approximately 1400 participants were planned for this study, however only 178 were enrolled prior to early termination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
178
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.
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
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.
Time frame: Day 1 up to Month 12
The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period)
Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions.
Time frame: Day 1 up to Month 12
The Cumulative Number of Gadolinium-enhancing Lesions on T1-weighted Images Measured at Months 6 and 12 (End of Placebo Controlled Period)
Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.
Time frame: Day 1 up to Month 12
Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume
Brain atrophy was defined by the percent brain volume change from baseline to Month 12
Time frame: Day 1 up to Month 12
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Teva Investigational Site 10192
Cullman, Alabama, United States
Teva Investigational Site 10204
Fresno, California, United States
Teva Investigational Site 10201
La Jolla, California, United States
Teva Investigational Site 10196
Centennial, Colorado, United States
Teva Investigational Site 10184
Miami, Florida, United States
Teva Investigational Site 10180
Sarasota, Florida, United States
Teva Investigational Site 10197
Sarasota, Florida, United States
Teva Investigational Site 10190
Tampa, Florida, United States
Teva Investigational Site 10207
Tampa, Florida, United States
Teva Investigational Site 10199
Vero Beach, Florida, United States
...and 159 more locations