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

• Status: Terminated
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ever Neuro Pharma GmbH
• Treatments: Cerebrolysin

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