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Study · Randomized controlled trial · n = 119 · 2013

4 results

A prospective, randomized, placebo-controlled, double-blind trial about safety and efficacy of combined treatment with alteplase (rt-PA) and Cerebrolysin in acute ischaemic hemispheric stroke.

Lang W, Stadler CH, Poljakovic Z, Fleet D

International journal of stroke : official journal of the International Stroke Society26 Sept 2012Cited by 72 (Europe PMC)

PMID23009193 (opens in a new tab)DOI10.1111/j.1747-4949.2012.00901.x (opens in a new tab)PepBankPUB-23009193
Publisher pagePubMedAsk about this study
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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.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In acute ischemic stroke patients receiving alteplase, Cerebrolysin did not improve modified Rankin Scale versus placebo at day 90.

    In plain wordsIn stroke patients receiving alteplase, Cerebrolysin did not improve the disability score versus placebo at day 90.

    Peptide
    Cerebrolysin
    Outcome
    No significant changeModified Rankin Scale at day 90
    Study

    n = 119

    Comparator
    Placebo after alteplase
    Analysis
    Primary
    Outcome group
    Exercise and physical function · Nervous system and cognition
    Studied dose
    30 ml daily · intravenous infusion · 10 consecutive daysAs given in this study (human).

    Source sentences

    Summary
    The third interim analysis did not show a benefit in the modified Rankin Scale for Cerebrolysin on day 90 compared to placebo and the study was stopped.
    2 context sentences
    Summary · context
    This placebo-controlled, double-blind trial involved 119 patients with acute ischaemic hemispheric stroke, randomly assigned to a combined treatment with alteplase plus Cerebrolysin or placebo (administered 1 h after thrombolytic treatment) starting within three-hours after onset of symptoms.
    Summary · context
    A daily i.v. infusion of 30 ml Cerebrolysin or placebo was given for 10 consecutive days.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In acute ischemic stroke patients receiving alteplase, Cerebrolysin increased NIHSS responders versus placebo after two-, five-, 10, and 30 days.

    In plain wordsIn stroke patients receiving alteplase, more patients responded with Cerebrolysin than placebo after two-, five-, 10, and 30 days.

    Peptide
    Cerebrolysin
    Outcome
    IncreaseNIHSS responders
    Study

    n = 119

    Comparator
    Placebo after alteplase
    Analysis
    Secondary
    Outcome group
    Neuroprotection · Nervous system and cognition
    Studied dose
    30 ml daily · intravenous infusion · 10 consecutive daysAs given in this study (human).

    Source sentences

    Summary
    The National Institutes of Health Stroke Scale responder analysis (secondary outcome measure) showed significantly more patients with an improvement of 6 or more points (or a total score of 0 or 1) after two-, five-, 10, and 30 days in the Cerebrolysin group.
    2 context sentences
    Summary · context
    This placebo-controlled, double-blind trial involved 119 patients with acute ischaemic hemispheric stroke, randomly assigned to a combined treatment with alteplase plus Cerebrolysin or placebo (administered 1 h after thrombolytic treatment) starting within three-hours after onset of symptoms.
    Summary · context
    A daily i.v. infusion of 30 ml Cerebrolysin or placebo was given for 10 consecutive days.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In acute ischemic stroke patients receiving alteplase, modified Rankin Scale responder trends with Cerebrolysin did not reach statistical significance versus placebo.

    In plain wordsIn stroke patients receiving alteplase, disability response trends with Cerebrolysin did not reach statistical significance versus placebo.

    Peptide
    Cerebrolysin
    Outcome
    No significant changeModified Rankin Scale responders
    Study

    n = 119

    Comparator
    Placebo after alteplase
    Outcome group
    Exercise and physical function · Nervous system and cognition
    Studied dose
    30 ml daily · intravenous infusion · 10 consecutive daysAs given in this study (human).

    Source sentences

    Summary
    Similar trends were observed for the modified Rankin Scale responder analysis without achieving statistical significance.
    2 context sentences
    Summary · context
    This placebo-controlled, double-blind trial involved 119 patients with acute ischaemic hemispheric stroke, randomly assigned to a combined treatment with alteplase plus Cerebrolysin or placebo (administered 1 h after thrombolytic treatment) starting within three-hours after onset of symptoms.
    Summary · context
    A daily i.v. infusion of 30 ml Cerebrolysin or placebo was given for 10 consecutive days.
  4. 04HumanRandomized controlled trialSafety outcome

    In acute ischemic stroke patients receiving alteplase, adverse events did not differ between Cerebrolysin and placebo groups.

    In plain wordsIn stroke patients receiving alteplase, adverse events did not differ between Cerebrolysin and placebo groups.

    Peptide
    Cerebrolysin
    Outcome
    No significant changeAdverse events
    Study

    n = 119

    Comparator
    Placebo after alteplase
    Outcome group
    Adverse events · Whole body
    Studied dose
    30 ml daily · intravenous infusion · 10 consecutive daysAs given in this study (human).

    Source sentences

    Summary
    There was no difference between treatment groups regarding adverse events.
    2 context sentences
    Summary · context
    This placebo-controlled, double-blind trial involved 119 patients with acute ischaemic hemispheric stroke, randomly assigned to a combined treatment with alteplase plus Cerebrolysin or placebo (administered 1 h after thrombolytic treatment) starting within three-hours after onset of symptoms.
    Summary · context
    A daily i.v. infusion of 30 ml Cerebrolysin or placebo was given for 10 consecutive days.

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

Registered trials3

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

3 trials · 1 completed · 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 pageClinicalTrials.govUpdated 9 Jul 2024
Status unknownPhase 4NCT06078215

CERebrolysine Effect on Blood-brain Barrier in acUte Ischemic Stroke

Poznan University of Medical Sciencesn = 35010 Jan 2023 to est. 31 Mar 2025

Acute Ischemic Stroke

Trial pageClinicalTrials.govUpdated 13 Oct 2023
CompletedPhase 3NCT00840671

Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke

Ever Neuro Pharma GmbHn = 119Oct 2005 to Jul 2008

Stroke

Trial pageClinicalTrials.govUpdated 28 Dec 2010

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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