Background: Cerebrolysin was successful in experimental models of cerebral ischemia and showed beneficial effects in clinical trials in acute stroke; a significant persistent effect was demonstrated in one large prospective, randomized, double-blind multicenter study (CARS 1).
Objective: To analyze the efficacy and safety of Cerebrolysin in recovery after stroke in the large prospective, randomized, double-blind, placebo-controlled, multicenter and parallel-group trial; study design was similar to CARS1.
Patients and methods: The study compared the effects of 30 ml Cerebrolysin versus placebo during early rehabilitation after stroke. Primary endpoint was the action research arm test (ARAT) score on day 90. Secondary, gait velocity, fine motor function, global neurological status, disability, quality of life, neglect, and depression were evaluated.
Results: 240 (120 vs. 120) patients were screened, enrolled, randomized, and treated in 15 study centers in Russia. 231 (114 vs. 117) patients completed the study period; only 9 patients discontinued the study prematurely.
Neither the primary ARAT score not the secondary outcome measures showed a significant treatment difference on day 90; as the mild baseline levels of impairment resulted in good recovery after 90 days also in the placebo.
Evaluation of vital signs and the global assessment of tolerability did not reveal clinically relevant changes both in the study course and between the treatment groups. Laboratory tests and vital signs did not show any abnormalities.
Conclusion: This study did not confirm the findings of the study CARS1, which showed a large effect size of Cerebrolysin as compared to Placebo. Cerebrolysin was well tolerated.
Article info
Identification
Copyright
© 2015 Published by Elsevier Inc.
