Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

What Was Tested

This registered phase 4 trial tested Cerebrolysin.

Object: To determine the effect of cerebrolysin on prolonged disorders of consciousness caused by hemorrhagic stroke.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 12 planned participants were the target.

It was open to people of any sex aged from 19 years up to 120 years.

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

Examples of who could join: Patients with hemorrhagic stroke confirmed by CT or MRI. Patients who have been in disorders of consciousness for more than 4 weeks after the onset of hemorrhagic stroke. Patients in a vegetative state or minimally conscious state (Coma Recovery Scale -revised: CRS-R assessment). Age: 19 to 80 years of age. Patients who have voluntarily given written informed consent to participate in the study by themselves or their legal representative.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: patients with confirmed epileptiform discharges on eeg; patients with brain parenchymal defects; patients with advanced liver, kidney, cardiac, or pulmonary disease.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Cerebrolysin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-06-01 with completion listed for 2026-09-30.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Coma Recovery Scale - revised (time frame: 2 days after randomization). Coma Recovery Scale - revised (time frame: 17 days after randomization). Positron Emitting Tomography (time frame: 2 days after randomization).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cerebrolysin in 12 people.

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

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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