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

The CARS (Cerebrolysin and Recovery After Stroke) trial was a randomized, double-blind, placebo-controlled, multicenter Phase II study that evaluated the efficacy of Cerebrolysin in motor recovery after ischemic stroke. Conducted across neurology centers in Central and Eastern Europe, the trial randomized 208 patients with moderate-to-severe ischemic stroke (NIHSS 6-16) affecting upper extremity function.

Initiated between 24 and 72 hours after the ischemic event, treatment consisted of 30 mL/day of intravenous Cerebrolysin for 21 days, in addition to standardized rehabilitation. The primary endpoint was upper extremity motor function recovery measured by the Action Research Arm Test (ARAT) at day 90.

Results showed large superiority of Cerebrolysin over placebo on ARAT (Mann-Whitney effect size 0.71; p < 0.0001), with small-to-medium superiority on global outcomes assessed by 12 different scales. Dropout rate was minimal (3.8%) and the safety profile was comparable to placebo, with no increase in serious adverse events.

Although the authors acknowledge that the relatively small sample size requires confirmation in larger trials, CARS provided robust clinical evidence for the use of Cerebrolysin as an adjunctive neurorestorative therapy in the acute and subacute phase of ischemic stroke. The study served as the basis for subsequent meta-analyses (CARS-1 + CARS-2) that reinforced the compound's benefit on motor and neurological outcomes.