Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke

What Was Tested

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

This study will enroll 80 subacute stroke patients with severe motor involvement.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 80 actual participants took part.

It was open to people of any sex aged from 19 years up to 80 years.

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

Examples of who could join: The first-ever stroke (ischemic). Confirmed by CT or MRI. Subacute stage: less than 1 week. Severe motor function involvement (FMA \< 50). Age: between 19 and 80 years.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: contraindication of mri; progressive or unstable stroke; pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia.

How the Study Was Run

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

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.

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 2016-03-14 with completion listed for 2019-02-14.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Score of Fugl-Meyer assessment (FMA) (time frame: 3 months after stroke).

It also tracked 7 secondary outcomes, for example Score of Korean version Modified Barthel Index (K-MBI), Score of National Institute of Health Stroke Scale (NIHSS), Score of Korean Version of Mini-Mental State Exam(K-MMSE) and Korean version of Montreal Cognitive Assessment (K-MoCA), Score of Action Research Arm Test (ARAT) and box and block test, Score of EuroQol (EQ-5D) and Days of Length of hospital stay.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cerebrolysin in 80 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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