Cerebrolysin and Recovery After XXXX (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial.

@entity1 @entity64 @entity33825
BACKGROUND AND PURPOSE: The aim of this trial was to investigate whether @entity64 @entity1 who receive Cerebrolysin show improved motor function in the upper extremities at day 90 compared with @entity1 who receive a placebo. METHODS: This study was a prospective, randomized, double-blind, placebo-controlled, multicenter, parallel-group study. @entity1 were treated with @entity33825 (30 mL/d) or a placebo (saline) once daily for 21 days, beginning at 24 to 72 hours after @entity64 onset. The @entity1 also participated in a standardized rehabilitation program for 21 days that was initiated within 72 hours after @entity64 onset. The primary end point was the Action Research Arm Test score on day 90. RESULTS: The nonparametric effect size on the Action Research Arm Test score on day 90 indicated a large superiority of Cerebrolysin compared with the placebo (Mann-Whitney estimator, 0.71; 95% confidence interval, 0.63-0.79; P<0.0001). The multivariate effect size on global status, as assessed using 12 different outcome scales, indicated a small-to-medium superiority of Cerebrolysin (Mann-Whitney estimator, 0.62; 95% confidence interval, 0.58-0.65; P<0.0001). The rate of premature discontinuation was <5% (3.8%). Cerebrolysin was safe and well tolerated. CONCLUSIONS: Cerebrolysin had a beneficial effect on function and global outcome in early rehabilitation @entity1 after @entity64 . Its safety was comparable with that of the placebo, suggesting a favorable benefit/risk ratio. Because this study was exploratory and had a relatively small sample size, the results should be confirmed in a large-scale, randomized clinical trial. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrialsregister.eu. Unique identifier: 2007-000870-21.
