Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage.

Woo PYM, Ho JWK, Ko NMW, Li RPT, Jian L, Chu ACH, Kwan MCL, Chan Y, Wong AKS, Wong HT, Chan KY, Kwok JCK

BMC neurology3 Nov 2020Cited by 13 (Europe PMC)

PMID33143640PMCIDPMC7607674DOI10.1186/s12883-020-01908-9PepBankPUB-33143640

Summary

AsbtractBACKGROUND: There are limited neuroprotective treatment options for patients with aneurysmal subarachnoid hemorrhage (SAH). Cerebrolysin, a brain-specific proposed pleiotropic neuroprotective agent, has been suggested to improve global functional outcomes in ischemic stroke. We investigated the efficacy, safety and feasibility of administering Cerebrolysin for SAH patients.MethodsThis was a prospective, randomized, double-blind, placebo-controlled, single-center, parallel-group pilot study. Fifty patients received either daily Cerebrolysin (30 ml/day) or a placebo (saline) for 14 days (25 patients per study group). The primary endpoint was a favorable Extended Glasgow Outcome Scale (GOSE) of 5 to 8 (moderate disability to good recovery) at six-months. Secondary endpoints included the modified Ranking Scale (mRS), the Montreal Cognitive Assessment (MOCA) score, occurrence of adverse effects and the occurrence of delayed cerebral ischemia (DCI).ResultsNo severe adverse effects or mortality attributable to Cerebrolysin were observed. No significant difference was detected in the proportion of patients with favorable six-month GOSE in either study group (odds ratio (OR): 1.49; 95% confidence interval (CI): 0.43-5.17). Secondary functional outcome measures for favorable six-month recovery i.e. a mRS of 0 to 3 (OR: 3.45; 95% CI 0.79-15.01) were comparable for both groups. Similarly, there was no difference in MOCA neurocognitive performance (p-value: 0.75) and in the incidence of DCI (OR: 0.85 95% CI: 0.28-2.59).ConclusionsUse of Cerebrolysin in addition to standard-of-care management of aneurysmal SAH is safe, well tolerated and feasible. However, the neutral results of this trial suggest that it does not improve the six-month global functional performance of patients.Clinical trial registrationName of Registry: ClinicalTrials.gov Trial Registration Number: NCT01787123 . Date of Registration: 8th February 2013.

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.

01HumanRandomized controlled trialEfficacy outcome
In patients with aneurysmal subarachnoid hemorrhage, favorable six-month GOSE did not differ significantly between Cerebrolysin and placebo.
In plain wordsIn patients with aneurysmal subarachnoid hemorrhage, favorable six-month recovery did not differ significantly between Cerebrolysin and placebo.
Peptide
Cerebrolysin
Outcome
No significant changeFavorable six-month GOSE
Study
n = 50
Comparator
Saline placebo
Analysis
Primary
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
30 ml/day · 14 daysAs given in this study (human).
Measurements
Odds ratio
1.49
favorable six-month GOSE
95% CI
0.43 to 5.17
favorable six-month GOSE
Source sentences
Summary
No significant difference was detected in the proportion of patients with favorable six-month GOSE in either study group (odds ratio (OR): 1.49; 95% confidence interval (CI): 0.43-5.17).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was a favorable Extended Glasgow Outcome Scale (GOSE) of 5 to 8 (moderate disability to good recovery) at six-months.
Summary · context
This was a prospective, randomized, double-blind, placebo-controlled, single-center, parallel-group pilot study.
Summary · context
Fifty patients received either daily Cerebrolysin (30 ml/day) or a placebo (saline) for 14 days (25 patients per study group).
Show in the study text Report a problemFND-3314364003
02HumanRandomized controlled trialEfficacy outcome
In patients with aneurysmal subarachnoid hemorrhage, favorable six-month mRS was comparable between Cerebrolysin and placebo.
In plain wordsIn patients with aneurysmal subarachnoid hemorrhage, favorable six-month disability scores were comparable between Cerebrolysin and placebo.
Peptide
Cerebrolysin
Outcome
No significant changeFavorable six-month mRS
Study
n = 50
Comparator
Saline placebo
Analysis
Secondary
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
30 ml/day · 14 daysAs given in this study (human).
Measurements
Odds ratio
3.45
mRS 0 to 3
95% CI
0.79 to 15.01
mRS 0 to 3
Source sentences
Summary
Secondary functional outcome measures for favorable six-month recovery i.e. a mRS of 0 to 3 (OR: 3.45; 95% CI 0.79-15.01) were comparable for both groups.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a prospective, randomized, double-blind, placebo-controlled, single-center, parallel-group pilot study.
Summary · context
Fifty patients received either daily Cerebrolysin (30 ml/day) or a placebo (saline) for 14 days (25 patients per study group).
Show in the study text Report a problemFND-3314364004
03HumanRandomized controlled trialEfficacy outcome
In patients with aneurysmal subarachnoid hemorrhage, MOCA performance did not differ between Cerebrolysin and placebo.
In plain wordsIn patients with aneurysmal subarachnoid hemorrhage, cognitive test performance did not differ between Cerebrolysin and placebo.
Peptide
Cerebrolysin
Outcome
No significant changeMOCA neurocognitive performance
Study
n = 50
Comparator
Saline placebo
Analysis
Secondary
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
30 ml/day · 14 daysAs given in this study (human).
Measurements
P
0.75
MOCA
Source sentences
Summary
Similarly, there was no difference in MOCA neurocognitive performance (p-value: 0.75) and in the incidence of DCI (OR: 0.85 95% CI: 0.28-2.59).
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary endpoints included the modified Ranking Scale (mRS), the Montreal Cognitive Assessment (MOCA) score, occurrence of adverse effects and the occurrence of delayed cerebral ischemia (DCI).
Summary · context
This was a prospective, randomized, double-blind, placebo-controlled, single-center, parallel-group pilot study.
Summary · context
Fifty patients received either daily Cerebrolysin (30 ml/day) or a placebo (saline) for 14 days (25 patients per study group).
Show in the study text Report a problemFND-3314364005
04HumanRandomized controlled trialEfficacy outcome
In patients with aneurysmal subarachnoid hemorrhage, delayed cerebral ischemia incidence did not differ between Cerebrolysin and placebo.
In plain wordsIn patients with aneurysmal subarachnoid hemorrhage, delayed brain ischemia did not differ between Cerebrolysin and placebo.
Peptide
Cerebrolysin
Outcome
No significant changeDelayed cerebral ischemia incidence
Study
n = 50
Comparator
Saline placebo
Analysis
Secondary
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30 ml/day · 14 daysAs given in this study (human).
Measurements
Odds ratio
0.85
DCI
95% CI
0.28 to 2.59
DCI
Source sentences
Summary
Similarly, there was no difference in MOCA neurocognitive performance (p-value: 0.75) and in the incidence of DCI (OR: 0.85 95% CI: 0.28-2.59).
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary endpoints included the modified Ranking Scale (mRS), the Montreal Cognitive Assessment (MOCA) score, occurrence of adverse effects and the occurrence of delayed cerebral ischemia (DCI).
Summary · context
This was a prospective, randomized, double-blind, placebo-controlled, single-center, parallel-group pilot study.
Summary · context
Fifty patients received either daily Cerebrolysin (30 ml/day) or a placebo (saline) for 14 days (25 patients per study group).
Show in the study text Report a problemFND-3314364006
05HumanRandomized controlled trialSafety outcome
In patients with aneurysmal subarachnoid hemorrhage, no severe adverse effects attributable to Cerebrolysin were observed.
In plain wordsIn patients with aneurysmal subarachnoid hemorrhage, no severe adverse effects attributable to Cerebrolysin were observed.
Peptide
Cerebrolysin
Outcome
Not applicableSevere adverse effects attributable to Cerebrolysin
Study
n = 25
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
30 ml/day · 14 daysAs given in this study (human).
Source sentences
Summary
No severe adverse effects or mortality attributable to Cerebrolysin were observed.
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary endpoints included the modified Ranking Scale (mRS), the Montreal Cognitive Assessment (MOCA) score, occurrence of adverse effects and the occurrence of delayed cerebral ischemia (DCI).
Summary · context
This was a prospective, randomized, double-blind, placebo-controlled, single-center, parallel-group pilot study.
Summary · context
Fifty patients received either daily Cerebrolysin (30 ml/day) or a placebo (saline) for 14 days (25 patients per study group).
Show in the study text Report a problemFND-3314364001
06HumanRandomized controlled trialSafety outcome
In patients with aneurysmal subarachnoid hemorrhage, no mortality attributable to Cerebrolysin was observed.
In plain wordsIn patients with aneurysmal subarachnoid hemorrhage, no deaths attributable to Cerebrolysin were observed.
Peptide
Cerebrolysin
Outcome
Not applicableMortality attributable to Cerebrolysin
Study
n = 25
Outcome group
Mortality · Whole body
Studied dose
30 ml/day · 14 daysAs given in this study (human).
Source sentences
Summary
No severe adverse effects or mortality attributable to Cerebrolysin were observed.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a prospective, randomized, double-blind, placebo-controlled, single-center, parallel-group pilot study.
Summary · context
Fifty patients received either daily Cerebrolysin (30 ml/day) or a placebo (saline) for 14 days (25 patients per study group).
Show in the study text Report a problemFND-3314364002

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 2/3NCT01787123

Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin™ in Patients With Aneurysmal Subarachnoid Hemorrhage

Kwong Wah Hospitaln = 501 Dec 2013 to 1 Jan 2019

Subarachnoid Hemorrhage · Intracranial Aneurysm · Delayed Cerebral Ischemia · Delayed Ischemic Neurological Deficit

Trial page ClinicalTrials.govUpdated 17 Oct 2019

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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