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

Phase 4

Terminated

• Conditions: Traumatic Brain Injury
• Interventions: Drug: 0.9% NaCl, saline; Drug: Cerebrolysin

• Registration Number: NCT01606111
• Lead Sponsor: Ever Neuro Pharma GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-25
• Study Start: 2013-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% NaCl, saline	0.9% NaCl, saline	-
Cerebrolysin	Cerebrolysin	-

Primary Outcome Measures

Name	Time	Method
Composite endpoint of mean score in MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E	Day 10	Global status is assessed by an ensemble of appropriate, single efficacy criteria to be tested by a multivariate, directional test approach
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	Day 90

Secondary Outcome Measures

Name	Time	Method
Mortality	Day 180
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	Day 180

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong