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

Ever Neuro Pharma

Status and phase

Terminated

Phase 4

Conditions

Traumatic Brain Injury

Treatments

Drug: Cerebrolysin

Drug: 0.9% NaCl, saline

Study type

Interventional

Funder types

Industry

Identifiers

NCT01606111

EVE-CN-0610

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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