Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study

What Was Tested

This registered not phased trial tested Cerebrolysin.

It had two arms (groups): Arm 1: Cerebrolysin Group (experimental) and Arm 2: Standard treatment only Group (other).

The patients in Arm 1 will be treated with cerebrolysin and standard treatment.

The patients in Arm 2 will receive standard treatment only.

The registry classes the interventions as drug and other.

More on the Plan

Cerebrolysin is a neuropeptide preparation from porcine brain in an aqueous solution.

Cerebrolysin has been registered for many years for the treatment of cerebrovascular and neurodegenerative diseases, as well as traumatic brain injuries worldwide.

Since the first approval, the treatment of ischemic stroke (IS) has progressed and new treatment concepts have been developed.

All patients will receive acute IS care according to local standards of care, which will not be changed or influenced by the study in any way.

Who Took Part

Enrollment: 30 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.

The full record lists 0 inclusion and 2 exclusion criteria; among the exclusions: previous stroke or disability (mrs \> 0); the patient unable to understand instructions.

How the Study Was Run

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

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

In this single-blind Cerebrolysin study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2025-06-13 with completion listed for 2027-07-15.

It ran at 1 site in Slovenia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 90-day Action Research Arm Test (ARAT) Score change (time frame: 90 days post-stroke).

It also tracked 5 secondary outcomes, for example National Institute of Health Stroke Scale (NIHSS) at discharge and 90 days, Modified Rankin Score (mRS) at day 90, Extended Barthel index (EBI) 90 days post-stroke, The De Morton Mobility Index (DEMMI) Score 90 days and Montreal Cognitive Assessment (MoCA) 90 days.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Cerebrolysin in 30 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.