Cerebrolysin and early neurorehabilitation in patients with acute ischemic stroke: a prospective, randomized, placebo-controlled clinical study.

Stan A, Birle C, Blesneag A, Iancu M

Journal of medicine and life1 Oct 2017Cited by 15 (Europe PMC)

PMID29362596PMCIDPMC5771251PepBankPUB-29362596

Summary

Background - Stroke represents one of the most important causes of permanent physical or mental disability. A number of recent advances in recovery have reinforced the idea that pharmacological intervention combined with a specific rehabilitation therapy can reduce disability after stroke. Objective - The aim of this trial was to demonstrate the hypothesis that the association of pharmacological treatment with Cerebrolysin to early physical therapy can significantly stimulate the endogenous processes underlying the recovery after an ischemic stroke. Methods and Results - It was a prospective, randomized, double-blind, placebo-controlled clinical study. 60 patients were randomized either to 30 ml/ day Cerebrolysin or to Placebo for 10 consecutive days, starting in the first 24-48 hours after stroke. The pharmacological treatment was paired with early physical rehabilitation. The robust nonparametric evaluation of the National Institute for Health Stroke Scale (NIHSS) demonstrated a large superiority of Cerebrolysin relative to placebo on day 10 with a MW=0.79 (95% CI, 0.65-0.94), respectively on day 30 with MW=0.75 (95% CI, 0.60-0.89). Similar results were found with modified Ranking Scale (mRS) and Barthel Index (BI). Cerebrolysin was safe and well tolerated. Conclusions - Cerebrolysin had a beneficial effect on global neurological status and disability. The beneficial results of this study can be easily applied in the current clinical practice. Abbreviations: BI = Barthel Index; CB = Changes from Baseline; CI = Confidence interval; ICH = International Conference on Harmonization; ITT = intention-to-treat; LB = Lower Bound of Confidence Interval; mRS = modified Rankin Scale; MW = Mann-Whitney; NIHSS = National Institute for Health Stroke Scale; P = P-value; R = Valid Number Reference Group (Placebo); SD = standard deviation; T = Valid Number Test Group (Cerebrolysin); UB = Upper Bound of Confidence Interval.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In acute ischemic stroke patients, Cerebrolysin improved NIHSS results versus placebo on day 10.
In plain wordsIn stroke patients, Cerebrolysin improved neurological scores more than placebo on day 10.
Peptide
Cerebrolysin
Outcome
DecreaseNIHSS day 10
Study
n = 60
Comparator
Placebo
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30 ml/day · 10 consecutive daysAs given in this study (human).
Measurements
Mann-Whitney estimator
0.79
day 10
95% CI
0.65 to 0.94
day 10
Source sentences
Summary
The robust nonparametric evaluation of the National Institute for Health Stroke Scale (NIHSS) demonstrated a large superiority of Cerebrolysin relative to placebo on day 10 with a MW=0.79 (95% CI, 0.65-0.94), respectively on day 30 with MW=0.75 (95% CI, 0.60-0.89).
3 context sentences(design, population, supporting numbers)
Summary · context
Methods and Results - It was a prospective, randomized, double-blind, placebo-controlled clinical study.
Summary · context
60 patients were randomized either to 30 ml/ day Cerebrolysin or to Placebo for 10 consecutive days, starting in the first 24-48 hours after stroke.
Summary · context
The pharmacological treatment was paired with early physical rehabilitation.
Show in the study text Report a problemFND-2936259601
02HumanRandomized controlled trialEfficacy outcome
In acute ischemic stroke patients, Cerebrolysin improved NIHSS results versus placebo on day 30.
In plain wordsIn stroke patients, Cerebrolysin improved neurological scores more than placebo on day 30.
Peptide
Cerebrolysin
Outcome
DecreaseNIHSS day 30
Study
n = 60
Comparator
Placebo
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30 ml/day · 10 consecutive daysAs given in this study (human).
Measurements
Mann-Whitney estimator
0.75
day 30
95% CI
0.6 to 0.89
day 30
Source sentences
Summary
The robust nonparametric evaluation of the National Institute for Health Stroke Scale (NIHSS) demonstrated a large superiority of Cerebrolysin relative to placebo on day 10 with a MW=0.79 (95% CI, 0.65-0.94), respectively on day 30 with MW=0.75 (95% CI, 0.60-0.89).
3 context sentences(design, population, supporting numbers)
Summary · context
Methods and Results - It was a prospective, randomized, double-blind, placebo-controlled clinical study.
Summary · context
60 patients were randomized either to 30 ml/ day Cerebrolysin or to Placebo for 10 consecutive days, starting in the first 24-48 hours after stroke.
Summary · context
The pharmacological treatment was paired with early physical rehabilitation.
Show in the study text Report a problemFND-2936259602
03HumanRandomized controlled trialEfficacy outcome
In acute ischemic stroke patients, Cerebrolysin improved modified Ranking Scale results versus placebo.
In plain wordsIn stroke patients, Cerebrolysin improved disability scale results more than placebo.
Peptide
Cerebrolysin
Outcome
DecreaseModified Ranking Scale
Study
n = 60
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
30 ml/day · 10 consecutive daysAs given in this study (human).
Source sentences
Summary
Similar results were found with modified Ranking Scale (mRS) and Barthel Index (BI).
4 context sentences(design, population, supporting numbers)
Summary · context
The robust nonparametric evaluation of the National Institute for Health Stroke Scale (NIHSS) demonstrated a large superiority of Cerebrolysin relative to placebo on day 10 with a MW=0.79 (95% CI, 0.65-0.94), respectively on day 30 with MW=0.75 (95% CI, 0.60-0.89).
Summary · context
Methods and Results - It was a prospective, randomized, double-blind, placebo-controlled clinical study.
Summary · context
60 patients were randomized either to 30 ml/ day Cerebrolysin or to Placebo for 10 consecutive days, starting in the first 24-48 hours after stroke.
Summary · context
The pharmacological treatment was paired with early physical rehabilitation.
Show in the study text Report a problemFND-2936259603
04HumanRandomized controlled trialEfficacy outcome
In acute ischemic stroke patients, Cerebrolysin improved Barthel Index results versus placebo.
In plain wordsIn stroke patients, Cerebrolysin improved daily activity scores more than placebo.
Peptide
Cerebrolysin
Outcome
IncreaseBarthel Index
Study
n = 60
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
30 ml/day · 10 consecutive daysAs given in this study (human).
Source sentences
Summary
Similar results were found with modified Ranking Scale (mRS) and Barthel Index (BI).
4 context sentences(design, population, supporting numbers)
Summary · context
The robust nonparametric evaluation of the National Institute for Health Stroke Scale (NIHSS) demonstrated a large superiority of Cerebrolysin relative to placebo on day 10 with a MW=0.79 (95% CI, 0.65-0.94), respectively on day 30 with MW=0.75 (95% CI, 0.60-0.89).
Summary · context
Methods and Results - It was a prospective, randomized, double-blind, placebo-controlled clinical study.
Summary · context
60 patients were randomized either to 30 ml/ day Cerebrolysin or to Placebo for 10 consecutive days, starting in the first 24-48 hours after stroke.
Summary · context
The pharmacological treatment was paired with early physical rehabilitation.
Show in the study text Report a problemFND-2936259604
05HumanRandomized controlled trialSafety outcome
In acute ischemic stroke patients, Cerebrolysin was safe and well tolerated.
In plain wordsIn stroke patients, Cerebrolysin was safe and well tolerated.
Peptide
Cerebrolysin
Outcome
Not applicableSafety and tolerability
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
30 ml/day · 10 consecutive daysAs given in this study (human).
Source sentences
Summary
Cerebrolysin was safe and well tolerated.
3 context sentences(design, population, supporting numbers)
Summary · context
Methods and Results - It was a prospective, randomized, double-blind, placebo-controlled clinical study.
Summary · context
60 patients were randomized either to 30 ml/ day Cerebrolysin or to Placebo for 10 consecutive days, starting in the first 24-48 hours after stroke.
Summary · context
The pharmacological treatment was paired with early physical rehabilitation.
Show in the study text Report a problemFND-2936259605

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 3NCT06052787

Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the ICU

Ain Shams Universityn = 1501 Sept 2023 to 1 Aug 2025

Traumatic Brain Injury

Trial page ClinicalTrials.govUpdated 19 Nov 2025

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

Subjects

Terms as the source lists them.

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