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

What Was Tested

This registered phase 2, phase 3 trial tested Cerebrolysin.

Cerebrolysin™ is a porcine-derived intravenous formulation composed of multiple lipid-soluble active agents that can cross the blood-brain barrier.

It is a registered medication in several countries indicated for stroke and Alzheimer's disease.

It had two arms (groups): Control: standard management (placebo comparator) and Intervention: standard management AND Cerebrolysin (active comparator).

Standard management for patient suffering from aneurysmal subarachnoid haemorrhage.

Standard management for aneurysmal subarachnoid hemorrhage and a 14-day administration of intravenous Cerebrolysin.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 50 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subarachnoid hemorrhage secondary to a ruptured intracranial aneurysm confirmed by computed tomography, magnetic resonance imaging or digital subtraction angiography. Any clinical grade of subarachnoid hemorrhage provided there is a reasonable prospect of survival. Initiation of trial medication within 96 hours from the time of presenting symptoms. Age 18-70 years-old. Reasonable expectation of completion of outcome measures at follow-up.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: unsalvageable patients: fixed and dilated pupils after resuscitation or signs of brainstem herniation that precludes definitive therapy; no previous history of cerebrolysin™ exposure; no known allergy to cerebrolysin™ or porcine tissue-derived products.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Cerebrolysin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cerebrolysin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Cerebrolysin.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2013-12-01 with completion listed for 2019-01-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Global functional performance (time frame: At six months after stroke).

It also tracked 8 secondary outcomes, for example Delayed ischemic neurological deficit (DIND) or delayed cerebral ischemia, Modified Barthel Index, Health Survey Short-form-12™ (SF-12™), Mini-mental state examination (MMSE), Neurobehavioural cognitive state examination (NCSE) and Cerebrolysin™-related adverse reactions.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Cerebrolysin in 50 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cerebrolysin compound page, all human trials.