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

Study Overview
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Brief Summary
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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.

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

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Drug: Cerebrolysin
* Drug: 0.9% NaCl, saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0.9% NaCl, saline<br> | Drug: 0.9% NaCl, saline<br>* 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)<br>* Other names: Saline;|
| Experimental: Cerebrolysin<br> | Drug: Cerebrolysin<br>* 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)<br>* Other names: Cognicer, Renacenz;|

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Day 10 | 
| Mortality |  | Day 30 | 
| 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 |