Safety and Efficacy of Cerebrolysin in Infants with Communication Defects due to Severe Perinatal Brain Insult: A Randomized Controlled Clinical Trial.

Hassanein SM, Deifalla SM, El-Houssinie M, Mokbel SA

Journal of clinical neurology (Seoul, Korea)11 Sept 2015Cited by 12 (Europe PMC)

PMID26365023PMCIDPMC4712290DOI10.3988/jcn.2016.12.1.79PepBankPUB-26365023

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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: CC BY-NC. 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 infants with severe perinatal brain insult, social scores rose 65.44% from baseline at 3 months with Cerebrolysin, and also rose 10% from baseline in the placebo group.
In plain wordsIn infants with severe brain injury around birth, social scores rose 65.44% from baseline with Cerebrolysin and 10% with placebo.
Peptide
Cerebrolysin
Outcome
IncreaseSocial score
Study
n = 60
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
0.1 mL/kg twice-weekly · injections · 5 weeksAs given in this study (human).
Measurements
Social score increase
65.44%
from baseline
p value for social score change
< 0.001
Cerebrolysin social score versus baseline, after 3 months
Social score increase
10%
placebo social score versus baseline, after 3 months
p value for social score change
< 0.01
placebo social score versus baseline, after 3 months
Source sentences
Summary
The scores of the Cerebrolysin group changed from concern to no concern, with increases of 65.44%, 45.54%, 358.06%, and 96.00% from baseline in the social (p<0.001), speech (p<0.001), symbolic (p<0.001), and total (p<0.001) scores.
Summary
After 3 months, the placebo group exhibited improvements in the social (p<0.01) and speech composite (p=0.02) scores, with 10% and 1.5% increases from baseline, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
A randomized placebo-controlled clinical trial was conducted in which 158 infants (age 6-21 months) with communication defects due to severe perinatal brain insult were enrolled; 120 infants completed the study.
Summary · context
The Cerebrolysin group (n=60) received twice-weekly Cerebrolysin injections of 0.1 mL/kg body weight for 5 weeks (total of ten injections).
Report a problemFND-2636502301
02HumanRandomized controlled trialEfficacy outcome
In infants with severe perinatal brain insult, speech scores rose 45.54% from baseline at 3 months with Cerebrolysin, and also rose 1.5% from baseline in the placebo group.
In plain wordsIn infants with severe brain injury around birth, speech scores rose 45.54% from baseline with Cerebrolysin and 1.5% with placebo.
Peptide
Cerebrolysin
Outcome
IncreaseSpeech score
Study
n = 60
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
0.1 mL/kg twice-weekly · injections · 5 weeksAs given in this study (human).
Measurements
Speech score increase
45.54%
from baseline
p value for speech score change
< 0.001
Cerebrolysin speech score versus baseline, after 3 months
Speech score increase
1.5%
placebo speech score versus baseline, after 3 months
p value for speech score change
0.02
placebo speech score versus baseline, after 3 months
Source sentences
Summary
The scores of the Cerebrolysin group changed from concern to no concern, with increases of 65.44%, 45.54%, 358.06%, and 96.00% from baseline in the social (p<0.001), speech (p<0.001), symbolic (p<0.001), and total (p<0.001) scores.
Summary
After 3 months, the placebo group exhibited improvements in the social (p<0.01) and speech composite (p=0.02) scores, with 10% and 1.5% increases from baseline, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
A randomized placebo-controlled clinical trial was conducted in which 158 infants (age 6-21 months) with communication defects due to severe perinatal brain insult were enrolled; 120 infants completed the study.
Summary · context
The Cerebrolysin group (n=60) received twice-weekly Cerebrolysin injections of 0.1 mL/kg body weight for 5 weeks (total of ten injections).
Report a problemFND-2636502302
03HumanRandomized controlled trialEfficacy outcome
In infants with perinatal brain insult, symbolic scores increased 358.06% from baseline with Cerebrolysin and changed from concern to no concern.
In plain wordsIn infants with severe brain injury around birth, symbolic scores increased 358.06% from baseline with Cerebrolysin.
Peptide
Cerebrolysin
Outcome
IncreaseSymbolic score
Study
n = 60
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
0.1 mL/kg twice-weekly · injections · 5 weeksAs given in this study (human).
Measurements
Symbolic score increase
358.06%
from baseline
p value for symbolic score change
< 0.001
Cerebrolysin symbolic score versus baseline, after 3 months
Source sentences
Summary
The scores of the Cerebrolysin group changed from concern to no concern, with increases of 65.44%, 45.54%, 358.06%, and 96.00% from baseline in the social (p<0.001), speech (p<0.001), symbolic (p<0.001), and total (p<0.001) scores.
2 context sentences(design, population, supporting numbers)
Summary · context
A randomized placebo-controlled clinical trial was conducted in which 158 infants (age 6-21 months) with communication defects due to severe perinatal brain insult were enrolled; 120 infants completed the study.
Summary · context
The Cerebrolysin group (n=60) received twice-weekly Cerebrolysin injections of 0.1 mL/kg body weight for 5 weeks (total of ten injections).
Report a problemFND-2636502303
04HumanRandomized controlled trialEfficacy outcome
In infants with perinatal brain insult, total communication scores increased 96.00% from baseline with Cerebrolysin and changed from concern to no concern.
In plain wordsIn infants with severe brain injury around birth, total communication scores increased 96.00% from baseline with Cerebrolysin.
Peptide
Cerebrolysin
Outcome
IncreaseTotal communication score
Study
n = 60
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
0.1 mL/kg twice-weekly · injections · 5 weeksAs given in this study (human).
Measurements
Total score increase
96%
from baseline
p value for total score change
< 0.001
Cerebrolysin total score versus baseline, after 3 months
Source sentences
Summary
The scores of the Cerebrolysin group changed from concern to no concern, with increases of 65.44%, 45.54%, 358.06%, and 96.00% from baseline in the social (p<0.001), speech (p<0.001), symbolic (p<0.001), and total (p<0.001) scores.
2 context sentences(design, population, supporting numbers)
Summary · context
A randomized placebo-controlled clinical trial was conducted in which 158 infants (age 6-21 months) with communication defects due to severe perinatal brain insult were enrolled; 120 infants completed the study.
Summary · context
The Cerebrolysin group (n=60) received twice-weekly Cerebrolysin injections of 0.1 mL/kg body weight for 5 weeks (total of ten injections).
Report a problemFND-2636502304

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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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