Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke

What Was Tested

This registered phase 4 trial tested Cerebrolysin.

This study will enroll 75 subacute stroke patients with unilateral motor dysfunction.

It had two arms (groups): Study Group 1 (experimental) and Study Group 2 (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 71 actual participants took part.

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: 1st cortical or subcortical unilateral infarction (supratentorial lesion). Confirmed by CT or MRI. Subacute stage: less than 1 week. Moderate to severe motor function involvement-total of FMA: 0-84. Age: between 18 and 80 years.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: progressive or unstable stroke; pre-existing and active major neurological disease; 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.

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.

The Cerebrolysin group and the comparison group ran side by side rather than switching.

As a double-blind Cerebrolysin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-01 with completion listed for 2014-01.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cerebrolysin in 71 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.