Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke

What Was Tested

The trial (phase 1, phase 2) is built around Cerebrolysin.

The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China.

Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo.

It had three arms (groups): Dl-3-n-butylphthalide (experimental), Cerebrolysin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 84 actual participants took part.

It was open to people of any sex aged from 30 years up to 90 years.

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

Examples of who could join: Acute ischemic stroke within 12 hours for the first time before entry into the study. National Institutes of Health Stroke Scale (NIHSS) score between 6 and 25.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: with lacunar infarction; with cerebral hemorrhagic infarction; with epilepsy or epileptic persons.

How the Study Was Run

It was run as a randomized, parallel-group and triple-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.

Blinding on both sides kept the participants and researchers unaware of who received Cerebrolysin.

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

It started in 2010-01 with completion listed for 2010-05.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: National Institutes of Health Stroke Scale Score (time frame: At 11-day and 21-day after therapy).

It also tracked 1 secondary outcome, for example Barthel Index Score.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Cerebrolysin in 84 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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