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

Traumatic Brain Injury Clinical Trial

— CAPTAIN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01606111
• Other study ID #: EVE-CN-0610
• Status: Terminated
• Phase: Phase 4
• Start date: September 2013
• Est. completion date: July 2015

Study information

• Verified date: February 2020
• Source: Ever Neuro Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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)
• 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)

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Ever Neuro Pharma GmbH

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

Poon W, Matula C, Vos PE, Muresanu DF, von Steinbüchel N, von Wild K, Hömberg 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Mortality		Day 10
Secondary	Mortality		Day 30
Secondary	Mortality		Day 90
Secondary	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
Secondary	Mortality		Day 180