Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage - a Prospective Randomized Open Blinded End-point Trial

What Was Tested

This registered phase 4 trial tested Cerebrolysin.

This study is designed to determine the safety and feasibility of using Cerebrolysin in treating primary intracerebral hemorrhage (ICH).

This is a multicenter, prospective, randomized, open-label, blinded end-point, phase IV parallel group study done in specialized stroke treatment centers in Poland.

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

Standard of care.

The registry classes the interventions as drug and other.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Age 18-80 years. NIHSS ≥8 at randomization. Stroke onset \<6h. Glasgow Coma Score (GCS) 5 to 12. Pre-stroke independence (modified Rankin Score 0 to 2).

The full record lists 9 inclusion and 22 exclusion criteria; among the exclusions: hemorrhage caused by head trauma; bilateral fixed dilated pupils; extensor motor posturing.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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.

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

Only one side, usually the participants, was kept unaware of whether Cerebrolysin was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2025-10-01 with completion listed for 2027-01-01.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Safety Outcome (time frame: 30 days from stroke onset).

It also tracked 5 secondary outcomes, for example Neurological deficit, Functional independence, Activities of daily living, Hematoma growth and Mortality.

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 not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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