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Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial
Dafin F Muresanu1, Wolf-Dieter Heiss2, Volker Hoemberg2
1From the Department of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania (D.F.M.); Max Planck Institute for Metabolism Research, Cologne, Germany (W.-D.H.); Department of Neurology, SHR Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany (V.H.); Department of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania (O.B.); Department of Neurology, "Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania (C.D.P.); Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany (J.C.V., V.W.R.); Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria (E.D., D.M., H.M.); Department of Neurology, Neurosurgery and Genetics, Russian National Research Medical University, Moscow City Hospital No. 8 for Neuropsychiatry, Moscow, Russia (A.G.); and "RoNeuro" Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania (D.F.M.). dafinm@ssnn.ro.
Cerebrolysin significantly improved upper extremity motor function in stroke patients by day 90 compared to placebo. This early rehabilitation treatment demonstrated a favorable safety profile, suggesting potential benefits for stroke recovery.
Area of Science:
- Neuroscience
- Clinical Neurology
- Pharmacology
Background:
- Stroke is a leading cause of long-term disability, necessitating effective rehabilitation strategies.
- Early intervention post-stroke is crucial for optimizing functional recovery.
- Cerebrolysin, a drug derived from porcine brain extract, is investigated for its neuroprotective and neurotrophic properties.
Purpose of the Study:
- To evaluate the efficacy of Cerebrolysin in improving upper extremity motor function in acute stroke patients.
- To compare the effects of Cerebrolysin versus placebo on functional outcomes at 90 days post-stroke.
- To assess the safety and tolerability of Cerebrolysin during early stroke rehabilitation.
Main Methods:
- A prospective, randomized, double-blind, placebo-controlled, multicenter trial.
- Patients received daily Cerebrolysin (30 mL) or placebo for 21 days, initiated 24-72 hours post-stroke.
- A standardized rehabilitation program was administered concurrently for 21 days.
Main Results:
- Cerebrolysin demonstrated a large superiority in upper extremity motor function (Action Research Arm Test score) at day 90 (effect size=0.71, P<0.0001).
- A small-to-medium superiority was observed in global status outcomes (effect size=0.62, P<0.0001).
- Cerebrolysin was found to be safe and well-tolerated, with discontinuation rates comparable to placebo (<5%).
Conclusions:
- Cerebrolysin positively impacts functional recovery and global outcomes in patients undergoing early stroke rehabilitation.
- The drug exhibits a favorable benefit/risk profile, comparable in safety to placebo.
- Further large-scale randomized trials are recommended to confirm these exploratory findings.
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