[A randomized, double-blind, placebo-controlled study of Cerebrolysin safety and efficacy in the treatment of acute ischemic stroke].

The aim of the study was to assess safety and efficacy of the neuroprotective drug Cerebrolysin in acute ischemic stroke. Thirty-six patients with ischemic stroke in carotid artery territory aged 45-85 years, were eligible for inclusion in the trial if they were admitted to the hospital within the first 12h after stroke onset. Patients were randomly and blindly assigned to placebo (n = 12) or 1 or 2 dosages of Cerebrolysin: 10 ml/d (n = 12) and 50 ml/d (n = 12) for 10 days with concomitant standard basic treatment in each group. A quantitative time-related analysis of the dynamics of neurological deficit revealed the tendency towards acceleration of improvement assessed by the Clinical Global Impression Scale and NIHSS in both Cerebrolysin groups by 30 day of the treatment. The significant reduction in the volume of MRI ischemic focus was shown in both Cerebrolysin groups (p < 0.05 vs Placebo) on day 3. Acute pharmacological test revealed a decrease (p < 0.05 vs Placebo) of the size and spread of delta and theta foci in 72.7% patients, receiving 50 ml/d of Cerebrolysin. In none of the cases, Cerebrolysin treatment provoked any paroxysmal activity on EEG. The trial demonstrated safety, efficacy and good tolerability of hige-dose Cerebrolysin in the treatment of ischemic stroke.

RCT Entities:   Population Interventions Outcomes