Evidence map›Paper›PMID 26564102›Full record

Trial reportStroke2016

Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial.

Dafin F Muresanu, Wolf-Dieter Heiss, Volker Hoemberg, Ovidiu Bajenaru, Cristian Dinu Popescu, Johannes C Vester, Volker W Rahlfs, Edith Doppler, Dieter Meier, Herbert Moessler and 1 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Stroke, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04751136 (Phase), which is not on this map. Cited by 68 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 11 pooled it
6.0field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04751136 phase2completednot on this map

Phase (2) Clinical Trial Studying the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome

TypeinterventionalSponsorMansoura University Children HospitalRan2016 to 2019Enrolled64ConditionsDown SyndromeArmscerebrolysin
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 11 syntheses or guidelines pooled it, 153 citations in OpenAlex.

  1. Pooled it
  2. Cerebrolysin for acute ischaemic stroke.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Cerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial series.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2021
    Pooled it
  4. Cerebrolysin for acute ischaemic stroke.The Cochrane database of systematic reviews · 2020
    Pooled it
  5. Safety and efficacy of Cerebrolysin in early post-stroke recovery: a meta-analysis of nine randomized clinical trials.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2018
    Pooled it
  6. Safety and efficacy of Cerebrolysin in motor function recovery after stroke: a meta-analysis of the CARS trials.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2017
    Pooled it
  7. Cerebrolysin for acute ischaemic stroke.The Cochrane database of systematic reviews · 2017
    Pooled it
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  10. Cerebrolysin for acute ischaemic stroke.The Cochrane database of systematic reviews · 2016
    Pooled it
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  17. Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2020
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8 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 4 countries.

Dafin F MuresanuFrom the Department of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania (D.F.M.); Max Planck Institute for Metabolism Research, Cologne, Germany (W.-D.H.); Department of Neurology, SHR Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany (V.H.); Department of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania (O.B.); Department of Neurology, "Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania (C.D.P.); Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany (J.C.V., V.W.R.); Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria (E.D., D.M., H.M.); Department of Neurology, Neurosurgery and Genetics, Russian National Research Medical University, Moscow City Hospital No. 8 for Neuropsychiatry, Moscow, Russia (A.G.); and "RoNeuro" Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania (D.F.M.). dafinm@ssnn.ro.
Wolf-Dieter HeissFrom the Department of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania (D.F.M.); Max Planck Institute for Metabolism Research, Cologne, Germany (W.-D.H.); Department of Neurology, SHR Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany (V.H.); Department of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania (O.B.); Department of Neurology, "Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania (C.D.P.); Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany (J.C.V., V.W.R.); Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria (E.D., D.M., H.M.); Department of Neurology, Neurosurgery and Genetics, Russian National Research Medical University, Moscow City Hospital No. 8 for Neuropsychiatry, Moscow, Russia (A.G.); and "RoNeuro" Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania (D.F.M.).
Volker HoembergFrom the Department of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania (D.F.M.); Max Planck Institute for Metabolism Research, Cologne, Germany (W.-D.H.); Department of Neurology, SHR Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany (V.H.); Department of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania (O.B.); Department of Neurology, "Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania (C.D.P.); Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany (J.C.V., V.W.R.); Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria (E.D., D.M., H.M.); Department of Neurology, Neurosurgery and Genetics, Russian National Research Medical University, Moscow City Hospital No. 8 for Neuropsychiatry, Moscow, Russia (A.G.); and "RoNeuro" Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania (D.F.M.).
Ovidiu BajenaruFrom the Department of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania (D.F.M.); Max Planck Institute for Metabolism Research, Cologne, Germany (W.-D.H.); Department of Neurology, SHR Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany (V.H.); Department of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania (O.B.); Department of Neurology, "Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania (C.D.P.); Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany (J.C.V., V.W.R.); Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria (E.D., D.M., H.M.); Department of Neurology, Neurosurgery and Genetics, Russian National Research Medical University, Moscow City Hospital No. 8 for Neuropsychiatry, Moscow, Russia (A.G.); and "RoNeuro" Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania (D.F.M.).
Cristian Dinu PopescuFrom the Department of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania (D.F.M.); Max Planck Institute for Metabolism Research, Cologne, Germany (W.-D.H.); Department of Neurology, SHR Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany (V.H.); Department of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania (O.B.); Department of Neurology, "Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania (C.D.P.); Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany (J.C.V., V.W.R.); Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria (E.D., D.M., H.M.); Department of Neurology, Neurosurgery and Genetics, Russian National Research Medical University, Moscow City Hospital No. 8 for Neuropsychiatry, Moscow, Russia (A.G.); and "RoNeuro" Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania (D.F.M.).
Johannes C VesterFrom the Department of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania (D.F.M.); Max Planck Institute for Metabolism Research, Cologne, Germany (W.-D.H.); Department of Neurology, SHR Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany (V.H.); Department of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania (O.B.); Department of Neurology, "Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania (C.D.P.); Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany (J.C.V., V.W.R.); Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria (E.D., D.M., H.M.); Department of Neurology, Neurosurgery and Genetics, Russian National Research Medical University, Moscow City Hospital No. 8 for Neuropsychiatry, Moscow, Russia (A.G.); and "RoNeuro" Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania (D.F.M.).
Volker W RahlfsFrom the Department of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania (D.F.M.); Max Planck Institute for Metabolism Research, Cologne, Germany (W.-D.H.); Department of Neurology, SHR Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany (V.H.); Department of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania (O.B.); Department of Neurology, "Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania (C.D.P.); Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany (J.C.V., V.W.R.); Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria (E.D., D.M., H.M.); Department of Neurology, Neurosurgery and Genetics, Russian National Research Medical University, Moscow City Hospital No. 8 for Neuropsychiatry, Moscow, Russia (A.G.); and "RoNeuro" Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania (D.F.M.).
Edith DopplerFrom the Department of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania (D.F.M.); Max Planck Institute for Metabolism Research, Cologne, Germany (W.-D.H.); Department of Neurology, SHR Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany (V.H.); Department of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania (O.B.); Department of Neurology, "Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania (C.D.P.); Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany (J.C.V., V.W.R.); Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria (E.D., D.M., H.M.); Department of Neurology, Neurosurgery and Genetics, Russian National Research Medical University, Moscow City Hospital No. 8 for Neuropsychiatry, Moscow, Russia (A.G.); and "RoNeuro" Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania (D.F.M.).
Dieter MeierFrom the Department of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania (D.F.M.); Max Planck Institute for Metabolism Research, Cologne, Germany (W.-D.H.); Department of Neurology, SHR Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany (V.H.); Department of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania (O.B.); Department of Neurology, "Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania (C.D.P.); Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany (J.C.V., V.W.R.); Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria (E.D., D.M., H.M.); Department of Neurology, Neurosurgery and Genetics, Russian National Research Medical University, Moscow City Hospital No. 8 for Neuropsychiatry, Moscow, Russia (A.G.); and "RoNeuro" Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania (D.F.M.).
Herbert MoesslerFrom the Department of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania (D.F.M.); Max Planck Institute for Metabolism Research, Cologne, Germany (W.-D.H.); Department of Neurology, SHR Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany (V.H.); Department of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania (O.B.); Department of Neurology, "Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania (C.D.P.); Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany (J.C.V., V.W.R.); Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria (E.D., D.M., H.M.); Department of Neurology, Neurosurgery and Genetics, Russian National Research Medical University, Moscow City Hospital No. 8 for Neuropsychiatry, Moscow, Russia (A.G.); and "RoNeuro" Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania (D.F.M.).
Alla GuekhtFrom the Department of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania (D.F.M.); Max Planck Institute for Metabolism Research, Cologne, Germany (W.-D.H.); Department of Neurology, SHR Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany (V.H.); Department of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania (O.B.); Department of Neurology, "Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania (C.D.P.); Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany (J.C.V., V.W.R.); Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria (E.D., D.M., H.M.); Department of Neurology, Neurosurgery and Genetics, Russian National Research Medical University, Moscow City Hospital No. 8 for Neuropsychiatry, Moscow, Russia (A.G.); and "RoNeuro" Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania (D.F.M.).
Moscow Research and Clinical Center for Neuropsychiatry · RUCarol Davila University of Medicine and Pharmacy · ROMax Planck Institute for Metabolism Research · DEPTV Group (Germany) · DEEVER Neuro Pharma (Austria) · ATPHV Dialysezentrum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeThe aim of this trial was to investigate whether stroke patients who receive Cerebrolysin show improved motor function in the upper extremities at day 90 compared with patients who receive a placebo.

methodsThis study was a prospective, randomized, double-blind, placebo-controlled, multicenter, parallel-group study. Patients were treated with Cerebrolysin (30 mL/d) or a placebo (saline) once daily for 21 days, beginning at 24 to 72 hours after stroke onset. The patients also participated in a standardized rehabilitation program for 21 days that was initiated within 72 hours after stroke onset. The primary end point was the Action Research Arm Test score on day 90.

resultsThe nonparametric effect size on the Action Research Arm Test score on day 90 indicated a large superiority of Cerebrolysin compared with the placebo (Mann-Whitney estimator, 0.71; 95% confidence interval, 0.63-0.79; P<0.0001). The multivariate effect size on global status, as assessed using 12 different outcome scales, indicated a small-to-medium superiority of Cerebrolysin (Mann-Whitney estimator, 0.62; 95% confidence interval, 0.58-0.65; P<0.0001). The rate of premature discontinuation was <5% (3.8%). Cerebrolysin was safe and well tolerated.

conclusionsCerebrolysin had a beneficial effect on function and global outcome in early rehabilitation patients after stroke. Its safety was comparable with that of the placebo, suggesting a favorable benefit/risk ratio. Because this study was exploratory and had a relatively small sample size, the results should be confirmed in a large-scale, randomized clinical trial. CLINICAL

trial registrationURL: http://www.clinicaltrialsregister.eu. Unique identifier: 2007-000870-21.

Indexed as

Recovery of FunctionAgedAmino AcidsDouble-Blind MethodFemaleHumansMaleMiddle AgedNeuroprotective AgentsProspective StudiesStrokeTreatment OutcomeAmino AcidscerebrolysinNeuroprotective AgentsCerebrolysinrandomized, double-blind, placebo-controlled trialrecovery of functionrehabilitationstroke

Identifiers

PMID26564102
PMCPMC4689177
OpenAlexW2173617262

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.