Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study

What Was Tested

This registered phase 4 trial tested Cerebrolysin.

The purpose of this study was to determine the effect of stroke on post-stroke level of consciousness through a double-blind, placebo-controlled, randomized study design.

And Brain 18F-FDG PET was used to reveal the mechanism of recovery after cerebrolysin administration.

Thirty patients with chronic stroke patients with minimal consciousness (MCS) or vegetative human (VS) level of consciousness disorder in the revised coma recovery scale were enrolled.

It had two arms (groups): Cerebrolysin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 19 years up to 90 years.

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

Examples of who could join: Ischemic or hemorrhagic stroke patients. Stroke with CT or MRI diagnosis. Chronic patients with more than 3 months of stroke onset. Patients with vegetative status or minimal consciousness (Coma Recovery Scale -revised: CRS-R). Age: 19 to 90 years old.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: in case of contraindications, including allergies to cerebrolysin; patients with contraindications to pet; progressive or unstable stroke.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-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, care provider, investigator and outcomes assessor.

It started in 2021-06 with completion listed for 2024-03.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): CRS-R (JFK Coma recovery scale-revised) (time frame: up to 11 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cerebrolysin in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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