Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial.

Heiss WD, Brainin M, Bornstein NM, Tuomilehto J, Hong Z

Stroke26 Jan 2012Cited by 83 (Europe PMC)

PMID22282884DOI10.1161/strokeaha.111.628537PepBankPUB-22282884

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

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

01HumanRandomized controlled trialEfficacy outcome
In acute ischemic stroke patients, Cerebrolysin did not significantly change the combined global directional endpoint compared with placebo.
In plain wordsIn patients with acute ischemic stroke, Cerebrolysin did not significantly improve the combined functional endpoint compared with placebo.
Peptide
Cerebrolysin
Outcome
No significant changeCombined global directional functional endpoint
Study
n = 1,070
Comparator
Placebo
Analysis
Primary
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
30 mL daily · intravenous infusion · 10 daysAs given in this study (human).
Source sentences
Summary
The confirmatory end point showed no significant difference between the treatment groups.
2 context sentences(design, population, supporting numbers)
Summary · context
The primary end point was the result of a combined global directional test of modified Rankin Scale, Barthel Index, and National Institutes of Health Stroke Scale.
Summary · context
Patients with acute ischemic hemispheric stroke were randomized within 12 hours of symptoms onset to active treatment (30 mL Cerebrolysin daily) or placebo (saline solution) given as intravenous infusion for 10 days in addition to aspirin (100 mg daily).
Report a problemFND-2228288401
02HumanRandomized controlled trialEfficacy outcome
In stroke patients with NIHSS >12, post hoc analysis showed a favorable Cerebrolysin trend versus placebo, with an OR of 1.27.
In plain wordsIn patients with severe stroke, Cerebrolysin showed a favorable stroke score trend compared with placebo in a post hoc analysis.
Peptide
Cerebrolysin
Outcome
No significant changeNIHSS in severe stroke subgroup
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
30 mL daily · intravenous infusion · 10 daysAs given in this study (human).
Measurements
NIHSS odds ratio
1.27
severe subgroup
CI lower bound
0.97
NIHSS
Source sentences
Summary
When stratified by severity however, a post hoc analysis of National Institutes of Health Stroke Scale and modified Rankin Scale showed a trend in favor of Cerebrolysin in patients with National Institutes of Health Stroke Scale >12 (National Institutes of Health Stroke Scale: OR, 1.27; CI lower bound, 0.97;
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with acute ischemic hemispheric stroke were randomized within 12 hours of symptoms onset to active treatment (30 mL Cerebrolysin daily) or placebo (saline solution) given as intravenous infusion for 10 days in addition to aspirin (100 mg daily).
Report a problemFND-2228288402
03HumanRandomized controlled trialEfficacy outcome
In stroke patients with NIHSS >12, post hoc analysis showed a favorable Cerebrolysin trend versus placebo on modified Rankin Scale.
In plain wordsIn patients with severe stroke, Cerebrolysin showed a favorable disability score trend compared with placebo in a post hoc analysis.
Peptide
Cerebrolysin
Outcome
No significant changeModified Rankin Scale in severe stroke subgroup
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
30 mL daily · intravenous infusion · 10 daysAs given in this study (human).
Measurements
Modified Rankin Scale odds ratio
1.27
severe subgroup
CI lower bound
0.9
modified Rankin Scale
Source sentences
Summary
When stratified by severity however, a post hoc analysis of National Institutes of Health Stroke Scale and modified Rankin Scale showed a trend in favor of Cerebrolysin in patients with National Institutes of Health Stroke Scale >12
2 context sentences(design, population, supporting numbers)
Summary · context
modified Rankin Scale: OR, 1.27; CI lower bound, 0.90).
Summary · context
Patients with acute ischemic hemispheric stroke were randomized within 12 hours of symptoms onset to active treatment (30 mL Cerebrolysin daily) or placebo (saline solution) given as intravenous infusion for 10 days in addition to aspirin (100 mg daily).
Report a problemFND-2228288403
04HumanRandomized controlled trialSafety outcome
In severe stroke patients, cumulative mortality by 90 days was 10.5% with Cerebrolysin versus 20.2% with placebo.
In plain wordsIn patients with severe stroke, mortality by 90 days was lower with Cerebrolysin than with placebo.
Peptide
Cerebrolysin
Outcome
DecreaseCumulative mortality by 90 days in severe stroke subgroup
Study
n: not reported in source
Comparator
Placebo
Outcome group
Mortality · Whole body
Studied dose
30 mL daily · intravenous infusion · 10 daysAs given in this study (human).
Measurements
Mortality
10.5%
Cerebrolysin
Mortality
20.2%
placebo
Hazard ratio
1.9661
reported contrast
CI lower bound
1.0013
hazard ratio
Source sentences
Summary
In this subgroup, the cumulative mortality by 90 days was 20.2% in the placebo and 10.5% in the Cerebrolysin group (hazard ratio, 1.9661; CI lower bound, 1.0013).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with acute ischemic hemispheric stroke were randomized within 12 hours of symptoms onset to active treatment (30 mL Cerebrolysin daily) or placebo (saline solution) given as intravenous infusion for 10 days in addition to aspirin (100 mg daily).
Report a problemFND-2228288404

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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