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Open Access 01-12-2020 | Subarachnoid Hemorrhage | Research article

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

Authors: Peter Y. M. Woo, Joanna W. K. Ho, Natalie M. W. Ko, Ronald P. T. Li, Leo Jian, Alberto C. H. Chu, Marco C. L. Kwan, Yung Chan, Alain K. S. Wong, Hoi-Tung Wong, Kwong-Yau Chan, John C. K. Kwok

Published in: BMC Neurology | Issue 1/2020

Asbtract

Background

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.

Methods

This 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).

Results

No 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).

Conclusions

Use 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 registration

Name of Registry: ClinicalTrials.gov

Trial Registration Number: NCT01787123.

Date of Registration: 8th February 2013.

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Title: Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage
Authors: Peter Y. M. Woo
Joanna W. K. Ho
Natalie M. W. Ko
Ronald P. T. Li
Leo Jian
Alberto C. H. Chu
Marco C. L. Kwan
Yung Chan
Alain K. S. Wong
Hoi-Tung Wong
Kwong-Yau Chan
John C. K. Kwok
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Subarachnoid Hemorrhage
Stroke
Subarachnoid Hemorrhage
Published in: BMC Neurology / Issue 1/2020
Electronic ISSN: 1471-2377
DOI: https://doi.org/10.1186/s12883-020-01908-9

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

Asbtract

Background

Methods

Results

Conclusions

Clinical trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Asbtract

Background

Methods

Results

Conclusions

Clinical trial registration

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