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

What Was Tested

Researchers studied Cerebrolysin in this randomized controlled trial publication.

BACKGROUND: There are limited neuroprotective treatment options for patients with aneurysmal subarachnoid hemorrhage (SAH).

Name of Registry: ClinicalTrials.gov Trial Registration Number: NCT01787123 .

Who Took Part

The abstract describes 25 patients taking part.

By PubMed's age tags, the people studied were adults, middle-aged adults and older adults, both men and women.

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).

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled, parallel-group and pilot study.

The patients were allocated by chance, so the Cerebrolysin group and the comparison group should start out alike.

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

Some patients received a placebo instead of Cerebrolysin, giving a reference point.

Groups ran in parallel: each of the patients stayed in one arm throughout.

This was a prospective, randomized, double-blind, placebo-controlled, single-center, parallel-group pilot study.

The primary endpoint was a favorable Extended Glasgow Outcome Scale (GOSE) of 5 to 8 (moderate disability to good recovery) at six-months.

What Was Measured

The subject headings attached to it are Amino Acids, Brain Ischemia, Glasgow Outcome Scale, Neuroprotective Agents, Pilot Projects and Subarachnoid Hemorrhage.

The authors tagged it with the keywords Aneurysmal subarachnoid hemorrhage, Delayed cerebral ischemia and Neuroprotection.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Cerebrolysin in 25 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Its findings take up roughly 6 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2020 (BMC neurology), a journal based in England.

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