The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery
Overview
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.
Full Title of Study: “A Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin in Patients With Traumatic Brain Injury”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: July 2015
Interventions
- 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)
- 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)
Arms, Groups and Cohorts
- Placebo Comparator: 0.9% NaCl, saline
- Experimental: Cerebrolysin
Clinical Trial Outcome Measures
Primary Measures
- 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
Secondary Measures
- 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
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Ever Neuro Pharma GmbH
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Wai S Poon, Prof., Principal Investigator, Prince of Wales Hospital
Citations Reporting on Results
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;:
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