Cerebrolysin as an Add-On Therapy to Standard Treatment of Basilar Artery Occlusion

What Was Tested

This registered early phase 1 trial tested Cerebrolysin.

The standard therapy for acute ischemic posterior circulation stroke (PCS) often leads to poor functional outcomes and high mortality rates, despite all advances in reperfusion therapy.

It had 1 arm (groups): Cerebrolysin group (experimental).

The registry classes the interventions as drug.

More on the Plan

All participants will receive the same standard of care and will be treated according to the latest European Stroke Organisation and American Stroke Organisation guidelines on acute stroke.

The Cerebrolysin administration will start no earlier than one hour after the standard treatment, and no later than 24 hours after the stroke symptom onset.

All possible side-effects will be closely monitored and in case of any adverse effect, the drug administration will be stopped, and the participant will be excluded from the further trial.

The clinical findings and outcomes will be quantified by the National Institutes of Health Stroke Scale (NIHSS) 24 hours, 14 days, 30 days, and 90 days post-stroke and by the Modified Rankin Scale on discharge and 90 days post-stroke.

Who Took Part

20 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age ≥ 18 years. Acute basilar artery occlusion confirmed on MSCT/ MR angiography. Premorbid mRS ≤ 3. Signed written consent.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: hypersensitivity to one of the components of the drug; breastfeeding and pregnancy; epilepsy, epileptic seizure.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Cerebrolysin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-07 with completion listed for 2025-05.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of participants in the Cerebrolysin group with the Modified Rankin Scale (mRS) score 0-3 at 90 days post-stroke compared to historical controls (time frame: 90 days (3 months) after the stroke). Mortality rate in the Cerebrolysin group compared to historical controls (time frame: 90 days (3 months) after the stroke).

It also tracked 2 secondary outcomes, for example Change in any and symptomatic intracerebral bleeding in the Cerebrolysin group compared to historical controls and Change in the National Institutes of Health Stroke Scale (NIHSS) compared to historical controls.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Cerebrolysin in 20 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.