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

Phase 4 Terminated 46 enrolled Ever Neuro Pharma GmbH

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this trial is to investigate safety and efficacy of Cerebrolysin as add-on therapy to standard care in patients with acute traumatic brain injury (TBI). The study duration for each patient is 180 days.

Timeline

Start: 2013-09
Primary completion: 2015-07
Completion: 2015-07

Outcome

Missed primary endpoint

Stopped (Enrollment): “Poor patient recruitment”

paper While for the primary multivariate ensemble, statistical significance was just missed in the intention-to-treat population PMID 31494820 ↗

Publications

Results Poon W, Matula C, Vos PE, Muresanu DF, von Steinbuchel N, von Wild K, Homberg V, Wang E, Lee TMC, Strilciuc S, Vester JC. Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial. Neurol Sci. 2020 Feb;41(2):281-293. doi: 10.1007/s10072-019-04053-5. Epub 2019 Sep 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cerebrolysin	Peptide	10 ml	Intravenous