Date: 2011-06-02
Type of information:
phase: 3
Announcement: completion of patient enrollment
Company: Teva Pharmaceutical Industries (Israel)
Product: Copaxone® (glatiramer acetate injection)
Action mechanism:
Disease: relapsing-remitting multiple sclerosis
Therapeutic area: Neurodegenerative diseases - Autoimmune diseases
Country: International study
Trial
details: This international Phase III trial in patients with relapsing-remitting multiple sclerosis (RRMS), is designed to examine the efficacy, safety and tolerability of 40mg Copaxone® (glatiramer acetate injection) administered three times a week compared to placebo. The primary endpoint of the trial is the total number of confirmed relapses during a 12-month placebo-controlled phase, which will be followed by an open-label extension phase.
The GALA study investigates glatiramer acetate 40mg administered three times a week in comparison to placebo. This dose (glatiramer acetate 40mg) is a higher strength than the currently marketed 20mg of Copaxone® injected daily.
Latest news: Teva Pharmaceutical Industries Ltd. has announced completion of patient enrollment for the GALA (Glatiramer Acetate Low-frequency Administration) trial. Patient enrollment was completed in May 2011, recruiting over 1,400 patients at 180 sites in the United States, Europe, Central Eastern Europe and Israel. Results from the trial are expected in the second quarter of 2012.
