Our objective was to assess the efficacy and safety of 40 mg/day @entity1638 (GA) in @entity1 with @entity2655 . We conducted a double-blind, randomized, placebo-controlled, multicentre trial. Three hundred and sixty-six @entity1 with definite, probable or probable laboratory supported @entity2655 and a slow vital capacity > or = 70% were randomly assigned to treatment with placebo or 40 mg GA daily. The primary intention-to-treat analysis was the comparison between the two treated groups of the rates of deterioration on the ALSFRSR scale. The secondary outcome measure was time to @entity204 , tracheostomy or permanent assisted ventilation. Safety and tolerability of GA were evaluated. After 52 weeks of follow-up, the slope of the ALSFRSR score was comparable in the both groups (placebo, -1.00+/-0.06/month; GA, -1.05+/-0.06/month; p=0.48). The secondary endpoint was non-significant with 159 @entity1 (87.4%) alive in the placebo group and 162 @entity1 (88.1%) in the GA group (log rank, p=0.75). The most common events were the injection site reactions (76.1% in the GA group, 14.8% in the placebo group), comparable to the known profile of 20 mg GA. In conclusion, GA at a dose of 40 mg/day did not show any beneficial effect in @entity2655 @entity1 , and safety and tolerability of GA were good in this population.

@entity1638 has no impact on disease progression in XXXX at 40 mg/day: a double- blind, randomized, multicentre, placebo-controlled trial.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity2655 :: ('MESH:C565957', 'Disease') :: ['ALS'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death'] @entity1638 :: ('MESH:C089995', 'Chemical') :: ['glatiramer acetate']
@entity2655 :: (MESH:C565957,Disease) :: ['ALS']
