RxTrials Institute Drug Pipeline Alert
March 19, 2008 | Vol. 6 No. 12
ALS Drug Fails to Meet Endpoint
Results from a Phase II study of glatiramer acetate (GA), Teva Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) treatment, show the candidate was safe and well tolerated. However, the study’s primary and secondary endpoints were not met.
The 366-patient, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study was conducted in 13 centers in Israel, Belgium, France, Germany, Italy and the UK. Patients received either GA 40 mg or placebo as a subcutaneous injection and continued treatment for 52 weeks, Teva said.
The primary outcome measure was change in ALS Functional Rating Scale-revised score. The secondary outcome measure was increased survival.
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