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Efficacy and safety of Cerebrolysin in patients with hemorrhagic stroke
O Bajenaru1, C Tiu, H Moessler
1Department of Neurology, University Hospital Bucharest, 169 Splaiul Independentei, District 5, 76251 Bucharest, Romania. ovalbajenaru@yahoo.com
Insights
Cerebrolysin treatment for hemorrhagic stroke was found to be safe and well-tolerated in this study. While not statistically significant, further research with larger sample sizes is recommended to confirm efficacy.
Area of Science:
- Neurology
- Clinical Trials
- Pharmacology
Background:
- Hemorrhagic stroke presents significant challenges in patient recovery.
- Cerebrolysin, a neuropeptide preparation, is being investigated for neurological conditions.
Purpose of the Study:
- To evaluate the safety and efficacy of Cerebrolysin in patients diagnosed with hemorrhagic stroke.
- To assess the clinical outcomes of a 10-day intravenous Cerebrolysin therapy.
Main Methods:
- Prospective, randomized, double-blind, placebo-controlled, parallel-group study.
- Efficacy assessed using the Unified Neurological Stroke Scale (UNSS), Barthel Index (BI), and Syndrome Short Test (SST).
- 100 patients were randomized, with 96 completing the 21-day trial.
Main Results:
- No statistically significant differences were observed between the Cerebrolysin and placebo groups across efficacy measures.
- Cerebrolysin treatment demonstrated a favorable safety profile and was well-tolerated by patients.
Conclusions:
- Cerebrolysin is safe and well-tolerated in patients with hemorrhagic stroke.
- The study did not achieve statistical significance in demonstrating efficacy for UNSS, BI, and SST changes.
- Larger sample size studies are warranted to provide definitive evidence of Cerebrolysin's efficacy in this patient population.
Unlabelled:
The purpose of the study was to investigate the efficacy and safety of Cerebrolysin in patients with hemorrhagic stroke. The primary objective of this trial was to assess the clinical efficacy and safety of a 10-days course of therapy with a daily administration of Cerebrolysin (50 mL i.v. per day). The trial had to demonstrate that Cerebrolysin treatment is safe in hemorrhagic stroke.
Methods:
The study was performed as a prospective, randomized, double blind, placebo-controlled, parallel group study with 2 treatment groups. Efficacy measures were the Unified Neurological Stroke Scale, Barthel Index, and Syndrome Short Test. The duration of the trial was of 21 days for each patient. Out of 100 randomized patients, a total of 96 (96%) completed the study.
Results:
Overall, no statistically significant group effects were observed based on single average comparisons at the individual visits. It could be shown that the treatment of hemorrhagic stroke with Cerebrolysin is safe and well tolerated.
Conclusion:
In the changes of UNSS, BI and SST from baseline to day 21, the group differences are not statistically significant; however, the use of Cerebrolysin in hemorrhagic stroke is safe and well tolerated and studies with a larger sample size may provide statistical evidence of Cerebrolysin's efficacy in patients with hemorrhagic stroke.
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