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

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ClinicalTrials.gov Identifier: NCT01606111
Recruitment Status : Unknown
Verified February 2015 by Ever Neuro Pharma GmbH.
Recruitment status was:  Active, not recruiting
First Posted : May 25, 2012
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Ever Neuro Pharma GmbH

Tracking Information
First Submitted Date  ICMJE May 21, 2012
First Posted Date  ICMJE May 25, 2012
Last Update Posted Date February 10, 2015
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2012)
  • Composite endpoint of mean score in MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 90 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
  • Composite endpoint including MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E [ Time Frame: 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 including 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 ]
  • Composite endpoint including 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 ]
Change History Complete list of historical versions of study NCT01606111 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2012)
  • Mortality [ Time Frame: Day 10 ]
  • Mortality [ Time Frame: Day 30 ]
  • Mortality [ Time Frame: 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 [ Time Frame: Day 180 ]
  • Mortality [ Time Frame: Day 180 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
  • Mortality [ Time Frame: Day 10 ]
  • Mortality [ Time Frame: Day 30 ]
  • Mortality [ Time Frame: Day 90 ]
  • Composite endpoint including 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 ]
  • Mortality [ Time Frame: Day 180 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin in Patients With Traumatic Brain Injury
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • 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 Name: Cognicer, Renacenz
  • 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 Name: Saline
Study Arms  ICMJE
  • Placebo Comparator: 0.9% NaCl, saline
    Intervention: Drug: 0.9% NaCl, saline
  • Experimental: Cerebrolysin
    Intervention: Drug: Cerebrolysin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 23, 2012)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01606111
Other Study ID Numbers  ICMJE EVE-CN-0610
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ever Neuro Pharma GmbH
Study Sponsor  ICMJE Ever Neuro Pharma GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wai S Poon, Prof. Prince of Wales Hospital
PRS Account Ever Neuro Pharma GmbH
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP