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

A Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin in Patients With Traumatic Brain Injury

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.

Study Overview

• Status: Terminated
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Drug: 0.9% NaCl, saline; Drug: Cerebrolysin

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cerebrolysin	Drug: Cerebrolysin; IV infusion, 50 ml/day, 10 days (treatment cycle will be repeated one and two months later if patient has a score of less than 7 in the extended Glasgow Outcome Scale on Day 30); Other Names: Cognicer, Renacenz
Placebo Comparator: 0.9% NaCl, saline	Drug: 0.9% NaCl, saline; IV infusion, 50 ml/day, 10 days (treatment cycle will be repeated one and two months later if patient has a score of less than 7 in the extended Glasgow Outcome Scale on Day 30); Other Names: Saline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	Day 30
Mortality	Day 10
Mortality	Day 90
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
Mortality	Day 180

Collaborators and Investigators

• Sponsor: Ever Neuro Pharma GmbH
• Investigators: Principal Investigator: Wai S Poon, Prof., Prince of Wales Hospital

Publications and helpful links

General Publications

• 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. Erratum In: Neurol Sci. 2020 Jan 6;:

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimate): May 25, 2012

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Physiological Effects of Drugs; Neuroprotective Agents; Protective Agents; Nootropic Agents; Cerebrolysin
• Other Study ID Numbers: EVE-CN-0610