Safety and efficacy of Cerebrolysin in early post-stroke recovery: a meta-analysis of nine randomized clinical trials.

Bornstein NM, Guekht A, Vester J, Heiss WD, Gusev E, Hömberg V, Rahlfs VW, Bajenaru O, Popescu BO, Muresanu D

Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology16 Dec 2017Cited by 85 (Europe PMC)

PMID29248999PMCIDPMC5884916DOI10.1007/s10072-017-3214-0PepBankPUB-29248999

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Summary

This meta-analysis combines the results of nine ischemic stroke trials, assessing efficacy of Cerebrolysin on global neurological improvement during early post-stroke period. Cerebrolysin is a parenterally administered neuropeptide preparation approved for treatment of stroke. All included studies had a prospective, randomized, double-blind, placebo-controlled design. The patients were treated with 30-50 ml Cerebrolysin once daily for 10-21 days, with treatment initiation within 72 h after onset of ischemic stroke. For five studies, original analysis data were available for meta-analysis (individual patient data analysis); for four studies, aggregate data were used. The combination by meta-analytic procedures was pre-planned and the methods of synthesis were pre-defined under blinded conditions. Search deadline for the present meta-analysis was December 31, 2016. The nonparametric Mann-Whitney (MW) effect size for National Institutes of Health Stroke Scale (NIHSS) on day 30 (or 21), combining the results of nine randomized, controlled trials by means of the robust Wei-Lachin pooling procedure (maximin-efficient robust test), indicated superiority of Cerebrolysin as compared with placebo (MW 0.60, P < 0.0001, N = 1879). The combined number needed to treat for clinically relevant changes in early NIHSS was 7.7 (95% CI 5.2 to 15.0). The additional full-scale ordinal analysis of modified Rankin Scale at day 90 in moderate to severe patients resulted in MW 0.61 with statistical significance in favor of Cerebrolysin (95% CI 0.52 to 0.69, P = 0.0118, N = 314). Safety aspects were comparable to placebo. Our meta-analysis confirms previous evidence that Cerebrolysin has a beneficial effect on early global neurological deficits in patients with acute ischemic stroke.

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 ischemic stroke patients, Cerebrolysin improved NIHSS at day 30 or 21 versus placebo.
In plain wordsIn stroke patients, Cerebrolysin improved neurological scores at day 30 or 21 compared with placebo.
Peptide
Cerebrolysin
Outcome
DecreaseNIHSS at day 30 or 21
Study
n = 1,879
Comparator
Placebo
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30-50 ml once daily · parenteral · 10-21 daysAs given in this study (human).
Measurements
MW
0.6
NIHSS
P
< 0.0001
NIHSS
Source sentences
Summary
indicated superiority of Cerebrolysin as compared with placebo (MW 0.60, P < 0.0001, N = 1879).
4 context sentences(design, population, supporting numbers)
Summary · context
This meta-analysis combines the results of nine ischemic stroke trials, assessing efficacy of Cerebrolysin on global neurological improvement during early post-stroke period.
Summary · context
Cerebrolysin is a parenterally administered neuropeptide preparation approved for treatment of stroke.
Summary · context
All included studies had a prospective, randomized, double-blind, placebo-controlled design.
Summary · context
The patients were treated with 30-50 ml Cerebrolysin once daily for 10-21 days, with treatment initiation within 72 h after onset of ischemic stroke.
Show in the study text Report a problemFND-2924899901
02HumanSystematic reviewEfficacy outcome
In moderate to severe ischemic stroke patients, Cerebrolysin improved modified Rankin Scale outcomes at day 90 versus placebo.
In plain wordsIn moderate to severe stroke patients, Cerebrolysin improved disability scores at day 90 compared with placebo.
Peptide
Cerebrolysin
Outcome
DecreaseModified Rankin Scale at day 90
Study
n = 314
Comparator
Placebo
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30-50 ml once daily · parenteral · 10-21 daysAs given in this study (human).
Measurements
MW
0.61
modified Rankin Scale
95% CI
0.52 to 0.69
MW
P
0.0118
modified Rankin Scale
Source sentences
Summary
The additional full-scale ordinal analysis of modified Rankin Scale at day 90 in moderate to severe patients resulted in MW 0.61 with statistical significance in favor of Cerebrolysin (95% CI 0.52 to 0.69, P = 0.0118, N = 314).
4 context sentences(design, population, supporting numbers)
Summary · context
This meta-analysis combines the results of nine ischemic stroke trials, assessing efficacy of Cerebrolysin on global neurological improvement during early post-stroke period.
Summary · context
Cerebrolysin is a parenterally administered neuropeptide preparation approved for treatment of stroke.
Summary · context
All included studies had a prospective, randomized, double-blind, placebo-controlled design.
Summary · context
The patients were treated with 30-50 ml Cerebrolysin once daily for 10-21 days, with treatment initiation within 72 h after onset of ischemic stroke.
Show in the study text Report a problemFND-2924899903
03HumanSystematic reviewEfficacy outcome
In ischemic stroke patients, the number needed to treat with Cerebrolysin versus placebo for clinically relevant early NIHSS changes was 7.7.
In plain wordsIn stroke patients, the number needed to treat with Cerebrolysin versus placebo for meaningful early neurological score changes was 7.7.
Peptide
Cerebrolysin
Outcome
Not applicableNumber needed to treat for clinically relevant NIHSS change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30-50 ml once daily · parenteral · 10-21 daysAs given in this study (human).
Measurements
NNT
7.7
clinically relevant early NIHSS changes
95% CI
5.2 to 15
NNT
Source sentences
Summary
The combined number needed to treat for clinically relevant changes in early NIHSS was 7.7 (95% CI 5.2 to 15.0).
4 context sentences(design, population, supporting numbers)
Summary · context
This meta-analysis combines the results of nine ischemic stroke trials, assessing efficacy of Cerebrolysin on global neurological improvement during early post-stroke period.
Summary · context
Cerebrolysin is a parenterally administered neuropeptide preparation approved for treatment of stroke.
Summary · context
All included studies had a prospective, randomized, double-blind, placebo-controlled design.
Summary · context
The patients were treated with 30-50 ml Cerebrolysin once daily for 10-21 days, with treatment initiation within 72 h after onset of ischemic stroke.
Show in the study text Report a problemFND-2924899902
04HumanSystematic reviewSafety outcome
In ischemic stroke trials, Cerebrolysin safety was comparable to placebo.
In plain wordsIn stroke trials, 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
30-50 ml once daily · parenteral · 10-21 daysAs given in this study (human).
Source sentences
Summary
Safety aspects were comparable to placebo.
4 context sentences(design, population, supporting numbers)
Summary · context
This meta-analysis combines the results of nine ischemic stroke trials, assessing efficacy of Cerebrolysin on global neurological improvement during early post-stroke period.
Summary · context
Cerebrolysin is a parenterally administered neuropeptide preparation approved for treatment of stroke.
Summary · context
All included studies had a prospective, randomized, double-blind, placebo-controlled design.
Summary · context
The patients were treated with 30-50 ml Cerebrolysin once daily for 10-21 days, with treatment initiation within 72 h after onset of ischemic stroke.
Show in the study text Report a problemFND-2924899904

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

CompletedPhase 4NCT00868283

The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke

Ever Neuro Pharma GmbHn = 1,071Sept 2006 to Feb 2011

Ischemic Stroke

Trial page ClinicalTrials.govUpdated 15 Dec 2023

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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