Safety and efficacy of Cerebrolysin in motor function recovery after stroke: a meta-analysis of the CARS trials.

Guekht A, Vester J, Heiss WD, Gusev E, Hoemberg V, Rahlfs VW, Bajenaru O, Popescu BO, Doppler E, Winter S, Moessler H, Muresanu D

Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology13 Jul 2017Cited by 42 (Europe PMC)

PMID28707130PMCIDPMC5605586DOI10.1007/s10072-017-3037-zPepBankPUB-28707130

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Summary

This meta-analysis combines the results of two identical stroke studies (CARS-1 and CARS-2) assessing efficacy of Cerebrolysin on motor recovery during early rehabilitation. Cerebrolysin is a parenterally administered neuropeptide preparation approved for the treatment of stroke. Both studies had a prospective, randomized, double-blind, placebo-controlled design. Treatment with 30 ml Cerebrolysin once daily for 3 weeks was started 24-72 h after stroke onset. In addition, patients participated in a standardized rehabilitation program for 21 days that was initiated within 72 h after stroke onset. For both studies, the original analysis data were used for meta-analysis (individual patient data analysis). The combination of these two studies by meta-analytic procedures was pre-planned, and the methods were pre-defined under blinded conditions. The nonparametric Mann-Whitney (MW) effect size of the two studies on the ARAT score on day 90 indicated superiority of Cerebrolysin compared with placebo (MW 0.62, P < 0.0001, Wei-Lachin pooling procedure, day 90, last observation carried forward; N = 442). Also, analysis of early benefit at day 14 and day 21 by means of the National Institutes of Health Stroke Scale, which is regarded as most sensitive to early improvements, showed statistical significance (MW 0.59, P < 0.002). The corresponding number-needed-to-treat (NNT) for clinically relevant changes in early NIHSS was 7.1 (95% CI: 4 to 22). Cerebrolysin had a beneficial effect on motor function and neurological status in early rehabilitation patients after acute ischemic stroke. Safety aspects were comparable to placebo, showing a favourable benefit/risk ratio.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanSystematic reviewEfficacy outcome
In stroke rehabilitation patients, Cerebrolysin improved ARAT motor recovery on day 90 versus placebo.
In plain wordsIn stroke rehabilitation patients, Cerebrolysin improved arm function on day 90 compared with placebo.
Peptide
Cerebrolysin
Outcome
IncreaseARAT score on day 90
Study
n = 442
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
30 ml once daily · 3 weeksAs given in this study (human).
Measurements
Mann-Whitney effect size
0.62
day 90
P value for ARAT comparison
< 0.0001
ARAT score on day 90, Cerebrolysin versus placebo, last observation carried forward
Source sentences
Summary
The nonparametric Mann-Whitney (MW) effect size of the two studies on the ARAT score on day 90 indicated superiority of Cerebrolysin compared with placebo (MW 0.62, P < 0.0001, Wei-Lachin pooling procedure, day 90, last observation carried forward; N = 442).
3 context sentences(design, population, supporting numbers)
Summary · context
This meta-analysis combines the results of two identical stroke studies (CARS-1 and CARS-2) assessing efficacy of Cerebrolysin on motor recovery during early rehabilitation.
Summary · context
Both studies had a prospective, randomized, double-blind, placebo-controlled design.
Summary · context
Treatment with 30 ml Cerebrolysin once daily for 3 weeks was started 24-72 h after stroke onset.
Show in the study text Report a problemFND-2870713001
02HumanSystematic reviewEfficacy outcome
In stroke rehabilitation patients, Cerebrolysin improved early NIHSS outcomes at day 14 and day 21 versus placebo.
In plain wordsIn stroke rehabilitation patients, Cerebrolysin improved neurological outcomes at day 14 and day 21 compared with placebo.
Peptide
Cerebrolysin
Outcome
DecreaseEarly NIHSS benefit at day 14 and day 21
Study
n: not reported in source
Comparator
Placebo
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30 ml once daily · 3 weeksAs given in this study (human).
Measurements
Mann-Whitney effect size
0.59
day 14 and day 21
P value for early NIHSS comparison
< 0.002
Early NIHSS benefit at day 14 and day 21, Cerebrolysin versus placebo
Source sentences
Summary
Also, analysis of early benefit at day 14 and day 21 by means of the National Institutes of Health Stroke Scale, which is regarded as most sensitive to early improvements, showed statistical significance (MW 0.59, P < 0.002).
3 context sentences(design, population, supporting numbers)
Summary · context
This meta-analysis combines the results of two identical stroke studies (CARS-1 and CARS-2) assessing efficacy of Cerebrolysin on motor recovery during early rehabilitation.
Summary · context
Both studies had a prospective, randomized, double-blind, placebo-controlled design.
Summary · context
Treatment with 30 ml Cerebrolysin once daily for 3 weeks was started 24-72 h after stroke onset.
Show in the study text Report a problemFND-2870713002
03HumanSystematic reviewEfficacy outcome
In stroke rehabilitation patients, the number needed to treat with Cerebrolysin for clinically relevant early NIHSS changes was 7.1 versus placebo.
In plain wordsIn stroke rehabilitation patients, the number needed to treat for meaningful early neurological changes was 7.1 with Cerebrolysin versus placebo.
Peptide
Cerebrolysin
Outcome
Not applicableNumber needed to treat for early NIHSS change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30 ml once daily · 3 weeksAs given in this study (human).
Measurements
Number needed to treat
7.1
early NIHSS
95% confidence interval for number needed to treat
4 to 22
Clinically relevant early NIHSS changes, Cerebrolysin versus placebo
Source sentences
Summary
The corresponding number-needed-to-treat (NNT) for clinically relevant changes in early NIHSS was 7.1 (95% CI: 4 to 22).
3 context sentences(design, population, supporting numbers)
Summary · context
This meta-analysis combines the results of two identical stroke studies (CARS-1 and CARS-2) assessing efficacy of Cerebrolysin on motor recovery during early rehabilitation.
Summary · context
Both studies had a prospective, randomized, double-blind, placebo-controlled design.
Summary · context
Treatment with 30 ml Cerebrolysin once daily for 3 weeks was started 24-72 h after stroke onset.
Show in the study text Report a problemFND-2870713003
04HumanSystematic reviewSafety outcome
In patients undergoing early stroke rehabilitation, Cerebrolysin safety was comparable to placebo.
In plain wordsIn patients undergoing early stroke rehabilitation, Cerebrolysin safety was comparable to placebo.
Peptide
Cerebrolysin
Outcome
No significant changeOverall safety
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
30 ml once daily · 3 weeksAs given in this study (human).
Source sentences
Summary
Safety aspects were comparable to placebo, showing a favourable benefit/risk ratio.
3 context sentences(design, population, supporting numbers)
Summary · context
This meta-analysis combines the results of two identical stroke studies (CARS-1 and CARS-2) assessing efficacy of Cerebrolysin on motor recovery during early rehabilitation.
Summary · context
Both studies had a prospective, randomized, double-blind, placebo-controlled design.
Summary · context
Treatment with 30 ml Cerebrolysin once daily for 3 weeks was started 24-72 h after stroke onset.
Show in the study text Report a problemFND-2870713004

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · source ClinicalTrials.gov (opens in a new tab)

Status unknownEarly phase 1NCT06489925

Cerebrolysin as an Add-On Therapy to Standard Treatment of Basilar Artery Occlusion

University Hospital Sestre Milosrdnicen = 20est. Jul 2024 to est. May 2026

Basilar Artery Occlusion · Posterior Circulation Brain Infarction

Trial page ClinicalTrials.govUpdated 9 Jul 2024

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

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