Study type: Human research · Status: Evidence verified by machine against declared source
Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial.
Stroke · 2016
Study scale: Cerebrolysin has been tested in several clinical trials during the acute phase after ischemic stroke,24–27 but these studies have had small sample sizes mainly ranging from 50 to 200 randomized patients.
Abstract only: Open source record
Product or molecular entity relationships
- Cerebrolysin: Exact entity relationship. Legacy citation custody associates this source with the catalog record; no product-relevance conclusion is implied.
Public plain-language summary
The published text is limited to the declared source and preserves reported uncertainty. It does not establish efficacy, safety, suitability, or evidence strength.
Research question
The aim of this trial was to investigate whether stroke patients who receive Cerebrolysin show improved motor function in the upper extremities at day 90 compared with patients who receive a placebo.
Study design
This study was a prospective, randomized, double-blind, placebo-controlled, multicenter, parallel-group study.
Participants or experimental system
Patients were treated with Cerebrolysin (30 mL/d) or a placebo (saline) once daily for 21 days, beginning at 24 to 72 hours after stroke onset.
Study scale
Cerebrolysin has been tested in several clinical trials during the acute phase after ischemic stroke,24–27 but these studies have had small sample sizes mainly ranging from 50 to 200 randomized patients.
Intervention or exposure
Ischemic stroke is the second most common cause of death worldwide and the third leading cause of the loss of disability-adjusted life years1,2; however, treatment remains insufficient and is only successful during the first hours after the attack if reperfusion of the ischemic territory can be achieved.
Comparator
Its safety was comparable with that of the placebo, suggesting a favorable benefit/risk ratio.
Outcomes examined
The primary end point was the Action Research Arm Test score on day 90.
Key findings
The nonparametric effect size on the Action Research Arm Test score on day 90 indicated a large superiority of Cerebrolysin compared with the placebo (Mann–Whitney estimator, 0.71; 95% confidence interval, 0.63–0.79; P<0.0001).
Limitations and uncertainty
Because this study was exploratory and had a relatively small sample size, the results should be confirmed in a large-scale, randomized clinical trial.
Product relevance and evidence boundary
This record is a published study, held here with its citation and review status. It is not a statement that any catalog item is effective, safe, or suitable for any use, and nothing in it is a dose or a protocol.
Evidence verified by machine against declared source. Verification is limited to the declared source and review scope. It does not mean independent replication or establish efficacy, safety, or suitability.