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

Sponsor
Ever Neuro Pharma GmbH (Industry)
Overall Status
Terminated
CT.gov ID
NCT01606111
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
21.9
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin in Patients With Traumatic Brain Injury
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    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 [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 [Day 90]

    Secondary Outcome Measures

    1. Mortality [Day 10]

    2. Mortality [Day 30]

    3. Mortality [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 [Day 180]

    5. Mortality [Day 180]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prince of Wales Hospital Hong Kong Hong Kong

    Sponsors and Collaborators

    • Ever Neuro Pharma GmbH

    Investigators

    • Principal Investigator: Wai S Poon, Prof., Prince of Wales Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ever Neuro Pharma GmbH
    ClinicalTrials.gov Identifier:
    NCT01606111
    Other Study ID Numbers:
    • EVE-CN-0610
    First Posted:
    May 25, 2012
    Last Update Posted:
    Feb 25, 2020
    Last Verified:
    Feb 1, 2020
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Wounds and Injuries
    Cerebrolysin

    Study Results

    No Results Posted as of Feb 25, 2020