The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke

What Was Tested

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

Study drug will be given once daily by intravenous infusion for 10 consecutive days.

Acetylsalicylic acid will be given orally, once daily throughout the study duration of 90 days as basic treatment.

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

The registry classes the interventions as drug.

Who Took Part

1071 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Age between 18 and 85 years. Clinical diagnosis of acute hemispheric ischemic stroke. CT or MRI results compatible with clinical diagnosis of acute hemispheric stroke. NIH Stroke Scale Score between 6 and 22, both inclusive. Functionally independent prior to stroke with a pre-stroke Rankin Score of 0 or 1.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: evidence on ct/mri of acute or chronic intracerebral hemorrhage, sah, avm, cerebral aneurysm, or neoplasm; systolic blood pressure over 220 mmhg or diastolic blood pressure over 120 mmhg on repeated measurement (interval of 30 min) prior to study entry; severe congestive heart failure or presentation with acute myocardial infarction at study entry.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Cerebrolysin and who got the comparison, which limits bias.

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

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 2006-09 with completion listed for 2010-10.

It ran at 49 sites in China (45), South Korea (3) and Hong Kong (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Modified Rankin Scale (time frame: 90 days after start of treatment). Barthel Index (time frame: 90 days after start of treatment). NIH Stroke Scale (time frame: 90 days after start of treatment).

It also tracked 2 secondary outcomes, for example SF-12 and Overall mortality.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cerebrolysin in 1071 people.

With 1071 participants it is a large trial for this field.

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.