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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Ever Neuro Pharma GmbH
Sponsor:
Information provided by (Responsible Party):
Ever Neuro Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01606111
First received: May 21, 2012
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Traumatic Brain Injury
Drug: Cerebrolysin
Drug: 0.9% NaCl, saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Ever Neuro Pharma GmbH:

Primary Outcome Measures:
  • Composite endpoint of mean score in MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: Day 10 ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Day 180 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 800
Study Start Date: September 2013
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Cognicer, Renacenz

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606111

Contacts
Contact: EVER Neuro Pharma +43 7665 20555 0

Locations
Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Wai S Poon, Prof.         
Principal Investigator: Wai S Poon, Prof.         
Sponsors and Collaborators
Ever Neuro Pharma GmbH
Investigators
Principal Investigator: Wai S Poon, Prof. Prince of Wales Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Ever Neuro Pharma GmbH
ClinicalTrials.gov Identifier: NCT01606111     History of Changes
Other Study ID Numbers: EVE-CN-0610
Study First Received: May 21, 2012
Last Updated: September 24, 2013
Health Authority: Hong Kong: Department of Health
Singapore: Health Sciences Authority
Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cerebrolysin
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Nootropic Agents

ClinicalTrials.gov processed this record on September 18, 2014