The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery

What Was Tested

The trial (phase 4) is built around Cerebrolysin.

The study duration for each patient is 180 days.

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

The registry classes the interventions as drug.

Who Took Part

46 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Clinical diagnosis of TBI and a GCS 7-12. Only isolated TBI. Pre-Trauma Karnofsky-Index = 100. Age 18-60 years. Male and female patients.

The full record lists 11 inclusion and 9 exclusion criteria; among the exclusions: evidence of pre-existing major health problems; injury of writing hand influencing cognitive or other outcome measures; clear clinical signs of intoxication influencing the evaluation.

How the Study Was Run

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

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.

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

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

It started in 2013-09 with completion listed for 2015-07.

It ran at 1 site in Hong Kong.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Composite endpoint of mean score in MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E (time frame: Day 10). Composite endpoint of mean score in PSI, Stroop Color-Word Test, Color Trails Test, Digit Span, Early Reha BI, Finger Tapping Test, MMSE, Hospital Anxiety and Depression Scale, GOS-E (time frame: Day 30). Composite endpoint of mean score in PSI, Stroop Color-Word Test, Color Trails Test, Digit Span, Early Reha BI, Finger Tapping Test, MMSE, Hospital Anxiety and Depression Scale, GOS-E (time frame: Day 90).

It also tracked 5 secondary outcomes, for example Mortality, Mortality, Mortality and Mortality.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cerebrolysin in 46 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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