28.02.2020

Captain Trial - Positive Results in TBI

CAPTAIN is a phase IIIb/IV single-center, prospective, randomized, double-blind, placebo-controlled clinical trial. Eligible patients with a Glasgow Coma Score (GCS) between 7 and 12 received study medication (50 ml of Cerebrolysin® or physiological saline solution per day for 10 days, followed by two additional treatment cycles with 10 ml per day for 10 days) in addition to standard care. An ensembles of efficacy criteria was tested for 90, 30, and 10 days after TBI with a priori ordered hypotheses using a multivariate, directional test, to reflect the global status of patients after TBI.

The study enrolled 142 patients, of which 139 underwent formal analysis.

The primary endpoint, a multidimensional ensemble of 13 outcome scales, indicated a medium–sized effect in favor of Cerebrolysin®, statistically significant at day 90. Safety and tolerability observations were comparable between treatment groups.

The whole study of CAPTAIN please find under following link: https://doi.org/10.1007/s10072-019-04181-y

Here the key benefits of Cerebrolysin® in TBI:

We asked the CAPTAIN key investigator Prof. Dafin Muresanu for an interview and discussed with him some topics like dosage regime of CAPTAIN study or the multidimensional approach which was used in this trial. Watch the video and get more background information about the CAPTAIN study!