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Trial · Interventional

TerminatedPhase 4Registry data

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

Short name CAPTAIN

NCTNCT01606111 (opens ClinicalTrials.gov in a new tab)Other idEVE-CN-0610
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 4
Enrollment
46 participants (actual)
Sponsor
Ever Neuro Pharma GmbH · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Hong Kong

Start
Sept 2013
Primary completion
Jul 2015
Completion
Jul 2015
First posted
25 May 2012 (estimated)
Last update posted
25 Feb 2020
Conditions
Traumatic Brain Injury

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 4

    CAPTAIN

    NCT01606111

    Sept 2013 to Jul 2015

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CerebrolysinDrug
  • 0.9% NaCl, salineDrug

Arms2

  • Placebo comparator

    0.9% NaCl, saline

  • Experimental

    Cerebrolysin

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Composite endpoint of mean score in MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E

    Time frame · Day 10

    Registry description

    Global status is assessed by an ensemble of appropriate, single efficacy criteria to be tested by a multivariate, directional test approach

  2. 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

  3. 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

Secondary outcomes(5)

  1. Mortality

    Time frame · Day 10

  2. Mortality

    Time frame · Day 30

  3. Mortality

    Time frame · Day 90

  4. 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 180

  5. Mortality

    Time frame · Day 180

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2020

Corrected

Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial.

Poon et al. 2020Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiologycited by 32

PMID 31494820DOI 10.1007/s10072-019-04053-5PUB-31494820

Full text at the publisher
Publisher pageRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Clinical diagnosis of TBI and a GCS 7-12 * Only isolated TBI * CT * Pre-Trauma Karnofsky-Index = 100 * Age 18-60 years * Male and female patients * Time to needle for study medication within 6 hours after injury * Patient is not pregnant or lactating during the trial and is not of childbearing potential * Patient was able to speak, read and write in a pre-defined study language before the accident. * Reasonable expectation of completion of outcome measures at follow-up * Written informed consent Exclusion Criteria: * Evidence of pre-existing major health problems * Any neurological or non-neurological condition independent from TBI that might influence the functional outcome or other efficacy outcome measures * Injury of writing hand influencing cognitive or other outcome measures * Clear clinical signs of intoxication influencing the evaluation * Major drug dependency including alcohol * Chronic treatment with steroids, Ca2+-channel blockers or major anticoagulants * Penetrating high-velocity missile head trauma * Stab wound trauma into the brain * Patients with spinal cord injury

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