CERebrolysine Effect on Blood-brain Barrier in acUte Ischemic Stroke

What Was Tested

In this phase 4 trial, researchers set out to test Cerebrolysin.

The study investigates whether Cerebrolysin stabilizes blood-brain barrier integrity in a manner that can be monitored using serum levels of the principal tight junction proteins, e.g., occludin (OCL), claudin-5 (CLN), and zonula occludens-1 (ZO-1), or other molecules known to be involved in BBB degradation, e.g., S100B and whether it protects against hemorrhagic transformation in ischemic stroke patients after reperfusion therapy (i.e. thrombolysis and/or mechanical thrombectomy).

It had three arms (groups): Thrombolysis and/or mechanical thrombectomy (no intervention), Cerebrolysin (experimental) and No reperfusion therapy / no cerebrolysin (no intervention).

Patients included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy - comparator.

Patients included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy and treated with Cerebrolysin.

Patients not referred to reperfusion therapy nor Cerebrolysin.

The registry classes the interventions as combination product.

More on the Plan

The severity of HT can be described using clinical and radiological tools and classified as asymptomatic/symptomatic, according to European Cooperative Acute Stroke Study classification and Heidelberg Bleeding Classification.

In patients who received reperfusion therapy (thrombolysis, mechanical thrombectomy), secondary HT had a negative influence on the clinical course and outcome.

Tight junction (TJ) proteins are important cell adhesion components that stabilize endothelium cells lining and are responsible for maintaining the BBB integrity.

Biomarkers of BBB damage that can be evaluated during the early phases of stroke might be useful for predicting the risk of HT.

Who Took Part

The registry lists 350 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: Acute ischemic stroke patients.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: no informed consent; primary or metastatic brain tumor; brain abscess.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Being open-label, the Cerebrolysin study did not mask who received what.

It started in 2023-01-10 with completion listed for 2025-01-31.

It ran at 1 site in Poland.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: National Institute of Health Stroke Scale (time frame: every day for 7 days after stroke onset). National Institute of Health Stroke Scale (time frame: at day 30 after stroke onset). Detection of hemorrhagic transformation [range o:1] (time frame: within 1 to 3 days after stroke onset, after worsening of clinical status by more than 4 points in NIHSS).

It also tracked 8 secondary outcomes, for example Modified Rankin scale [range 0:6], Modified Rankin scale [range 0:6], Modified Rankin scale [range 0:6], Modified Rankin scale [range 0:6], Barthel Index for Activities of Daily Living (ADL) [range 0:100] and Barthel Index for Activities of Daily Living (ADL) [range 0:100].

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cerebrolysin in 350 people.

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.