Clinical trial NCT01606111: The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin in Patients With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Traumatic Brain Injury
Lead sponsor: Ever Neuro Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2012-05-25
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Composite endpoint of mean score in MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E
timeFrame: Day 10
measure: 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
timeFrame: Day 30
measure: 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
timeFrame: Day 90
Secondary outcomes:
measure: Mortality
timeFrame: Day 10
measure: Mortality
timeFrame: Day 30
measure: Mortality
timeFrame: Day 90
measure: 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
timeFrame: Day 180
measure: Mortality
timeFrame: Day 180
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Prince of Wales Hospital
name: Wai S Poon, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.