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Study · Randomized controlled trial · n = 100 · 2017

6 results

Efficacy and safety of Cerebrolysin treatment in early recovery after acute ischemic stroke: a randomized, placebo-controlled, double-blinded, multicenter clinical trial.

Gharagozli K, Harandi AA, Houshmand S, Akbari N, Muresanu DF, Vester J, Winter S, Moessler H

Journal of medicine and life1 Jul 2017Cited by 35 (Europe PMC)

PMID29075343 (opens in a new tab)PMCIDPMC5652261 (opens in a new tab)PepBankPUB-29075343
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Summary

Background and Purpose : The aim of this study was to evaluate the efficacy, safety, and tolerability of cerebrolysin in the early recovery phase after acute ischemic stroke. Methods. This prospective, randomized, double-blinded, placebo-controlled, multicenter, parallel-group study enrolled a total of 100 patients within 18 h after the onset of stroke. The patients were treated with Cerebrolysin (30 mL over seven days followed by 10 mL until day 30) or placebo once daily over a period of four weeks. Efficacy was primarily assessed by the NIH Stroke Scale at day 30, and additional parameters included the modified Rankin Scale, the Clinical Global Impression, the Patient Global Satisfaction (PGS) and the Mini Mental State Examination (MMSE). Nonparametric statistical procedures employing the Wilcoxon-Mann-Whitney test were used for data analysis. Safety and tolerability were assessed by adverse events, vital signs, and laboratory parameters. Results.The estimated effect size on the change from baseline in the NIH Stroke Scale on day 30 indicated a medium to large superiority of cerebrolysin compared to placebo (Mann-Whitney [MW] 0.66; 95% confidence interval [CI] 0.55-0.78, P=0.005). Similar effect sizes were reported for the modified Ranking Scale (MW 0.65; 95% CI 0.54-0.76; P=0.010) and the Clinical Global Impression (MW 0.70; 95% CI 0.55-0.85; P=0.006). Effect sizes in the MMSE and PGS did not reach statistical significance. No significant group differences were seen in any of the safety parameters. Conclusions. Cerebrolysin was effective, safe, and well tolerated in the early recovery phase after acute ischemic stroke and significantly improved neurological and global function outcomes compared to placebo.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with acute ischemic stroke, Cerebrolysin improved NIH Stroke Scale change at day 30 versus placebo.

    In plain wordsIn stroke patients, Cerebrolysin improved neurological scores at day 30 compared with placebo.

    Peptide
    Cerebrolysin
    Outcome
    DecreaseNIH Stroke Scale change at day 30
    Study

    n = 100

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Neuroprotection · Nervous system and cognition
    Studied dose
    30 mL over seven days followed by 10 mL until day 30 · four weeksAs given in this study (human).

    Measurements

    Mann-Whitney effect size
    0.66
    NIH Stroke Scale at day 30
    95% confidence interval for Mann-Whitney effect size
    0.55 to 0.78
    NIH Stroke Scale change from baseline at day 30, Cerebrolysin versus placebo
    p value for NIH Stroke Scale change from baseline at day 30
    0.005
    NIH Stroke Scale change from baseline at day 30, Cerebrolysin versus placebo

    Source sentences

    Summary
    Results.The estimated effect size on the change from baseline in the NIH Stroke Scale on day 30 indicated a medium to large superiority of cerebrolysin compared to placebo (Mann-Whitney [MW] 0.66; 95% confidence interval [CI] 0.55-0.78, P=0.005).
    2 context sentences
    Summary · context
    This prospective, randomized, double-blinded, placebo-controlled, multicenter, parallel-group study enrolled a total of 100 patients within 18 h after the onset of stroke.
    Summary · context
    The patients were treated with Cerebrolysin (30 mL over seven days followed by 10 mL until day 30) or placebo once daily over a period of four weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with acute ischemic stroke, Cerebrolysin improved modified Rankin Scale outcomes versus placebo.

    In plain wordsIn stroke patients, Cerebrolysin improved disability scores compared with placebo.

    Peptide
    Cerebrolysin
    Outcome
    DecreaseModified Rankin Scale
    Study

    n = 100

    Comparator
    Placebo
    Outcome group
    Exercise and physical function · Nervous system and cognition
    Studied dose
    30 mL over seven days followed by 10 mL until day 30 · four weeksAs given in this study (human).

    Measurements

    Mann-Whitney effect size
    0.65
    modified Ranking Scale
    95% confidence interval for Mann-Whitney effect size
    0.54 to 0.76
    modified Ranking Scale, Cerebrolysin versus placebo
    p value for modified Ranking Scale
    0.01
    modified Ranking Scale, Cerebrolysin versus placebo

    Source sentences

    Summary
    Similar effect sizes were reported for the modified Ranking Scale (MW 0.65; 95% CI 0.54-0.76; P=0.010) and the Clinical Global Impression (MW 0.70; 95% CI 0.55-0.85; P=0.006).
    2 context sentences
    Summary · context
    This prospective, randomized, double-blinded, placebo-controlled, multicenter, parallel-group study enrolled a total of 100 patients within 18 h after the onset of stroke.
    Summary · context
    The patients were treated with Cerebrolysin (30 mL over seven days followed by 10 mL until day 30) or placebo once daily over a period of four weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with acute ischemic stroke, Cerebrolysin improved Clinical Global Impression outcomes versus placebo.

    In plain wordsIn stroke patients, Cerebrolysin improved the overall clinical assessment compared with placebo.

    Peptide
    Cerebrolysin
    Outcome
    DecreaseClinical Global Impression
    Study

    n = 100

    Comparator
    Placebo
    Outcome group
    Neuroprotection · Nervous system and cognition
    Studied dose
    30 mL over seven days followed by 10 mL until day 30 · four weeksAs given in this study (human).

    Measurements

    Mann-Whitney effect size
    0.7
    Clinical Global Impression
    95% confidence interval for Mann-Whitney effect size
    0.55 to 0.85
    Clinical Global Impression, Cerebrolysin versus placebo
    p value for Clinical Global Impression
    0.006
    Clinical Global Impression, Cerebrolysin versus placebo

    Source sentences

    Summary
    Similar effect sizes were reported for the modified Ranking Scale (MW 0.65; 95% CI 0.54-0.76; P=0.010) and the Clinical Global Impression (MW 0.70; 95% CI 0.55-0.85; P=0.006).
    2 context sentences
    Summary · context
    This prospective, randomized, double-blinded, placebo-controlled, multicenter, parallel-group study enrolled a total of 100 patients within 18 h after the onset of stroke.
    Summary · context
    The patients were treated with Cerebrolysin (30 mL over seven days followed by 10 mL until day 30) or placebo once daily over a period of four weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with acute ischemic stroke, Cerebrolysin did not significantly improve MMSE outcomes versus placebo.

    In plain wordsIn stroke patients, Cerebrolysin did not significantly improve mental-state scores compared with placebo.

    Peptide
    Cerebrolysin
    Outcome
    No significant changeMini Mental State Examination
    Study

    n = 100

    Comparator
    Placebo
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    30 mL over seven days followed by 10 mL until day 30 · four weeksAs given in this study (human).

    Source sentences

    Summary
    Effect sizes in the MMSE and PGS did not reach statistical significance.
    2 context sentences
    Summary · context
    This prospective, randomized, double-blinded, placebo-controlled, multicenter, parallel-group study enrolled a total of 100 patients within 18 h after the onset of stroke.
    Summary · context
    The patients were treated with Cerebrolysin (30 mL over seven days followed by 10 mL until day 30) or placebo once daily over a period of four weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with acute ischemic stroke, Cerebrolysin did not significantly improve Patient Global Satisfaction versus placebo.

    In plain wordsIn stroke patients, Cerebrolysin did not significantly improve patient satisfaction compared with placebo.

    Peptide
    Cerebrolysin
    Outcome
    No significant changePatient Global Satisfaction
    Study

    n = 100

    Comparator
    Placebo
    Outcome group
    Patient-reported outcomes · Whole body
    Studied dose
    30 mL over seven days followed by 10 mL until day 30 · four weeksAs given in this study (human).

    Source sentences

    Summary
    Effect sizes in the MMSE and PGS did not reach statistical significance.
    2 context sentences
    Summary · context
    This prospective, randomized, double-blinded, placebo-controlled, multicenter, parallel-group study enrolled a total of 100 patients within 18 h after the onset of stroke.
    Summary · context
    The patients were treated with Cerebrolysin (30 mL over seven days followed by 10 mL until day 30) or placebo once daily over a period of four weeks.
  6. 06HumanRandomized controlled trialSafety outcome

    In patients with acute ischemic stroke, no significant group differences were seen between Cerebrolysin and placebo in any safety parameter.

    In plain wordsIn stroke patients, safety measures did not differ significantly between Cerebrolysin and placebo.

    Peptide
    Cerebrolysin
    Outcome
    No significant changeSafety parameters
    Study

    n = 100

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    30 mL over seven days followed by 10 mL until day 30 · four weeksAs given in this study (human).

    Source sentences

    Summary
    No significant group differences were seen in any of the safety parameters.
    3 context sentences
    Summary · context
    Safety and tolerability were assessed by adverse events, vital signs, and laboratory parameters.
    Summary · context
    This prospective, randomized, double-blinded, placebo-controlled, multicenter, parallel-group study enrolled a total of 100 patients within 18 h after the onset of stroke.
    Summary · context
    The patients were treated with Cerebrolysin (30 mL over seven days followed by 10 mL until day 30) or placebo once daily over a period of four weeks.

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

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.

  1. Version 2Current

    14 Oct 2026, 05:02 UTC

    Study results updated

  2. Version 1

    14 Oct 2026, 01:46 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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