Ischemic stroke is the second most common cause of death worldwide, and the third leading cause of loss of disability-adjusted life years. Cerebrolysin, a neuropeptide preparation consisting of low molecular weight neuropeptides and free amino acids, has been shown by animal studies to have neuroprotective properties. This study analyzed the efficacy and safety of cerebro-lysin during post-stroke recovery.

Adult patients with ischemic supratentorial strokes were recruited for randomization. The subjects received either cerebrolysin, at 30 mL per day, or a placebo, once daily for 21 days, beginning at one to three days after stroke onset. The primary efficacy criterion was the change in the Action Research Arm Test (ARAT) of upper limb motor function from baseline to day 90. Secondary outcome measures were changes from baseline in gait velocity, fine motor function, global neurologic state, level of disability or dependence in activities of daily living, aphasia, neglect, quality of life and depression.

For the 205 patients included in the study, the ARAT scores improved from 10.1 at baseline to 40.7 on day 90 in the cerebrolysin group, and from 10.7 to 26.5 in the placebo group(P<0.0001). A multivariate assessment of global status, as assessed by 12 outcome measures, demonstrated superiority of the treatment group as compared to the placebo group (P<0.0001).

This study of patients with ischemic stroke found that treatment with cerebrolysin, beginning 24 to 72 hours after stroke onset, had a beneficial effect on functional and global outcome.