Overview

This trial is active, not recruiting.

Condition traumatic brain injury
Treatments cerebrolysin, 0.9% nacl, saline
Phase phase 4
Sponsor Ever Neuro Pharma GmbH
Start date September 2013
End date June 2015
Trial size 800 participants
Trial identifier NCT01606111, EVE-CN-0610

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
0.9% nacl, saline 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)
(Experimental)
cerebrolysin Cognicer, Renacenz
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)

Primary Outcomes

Measure
Composite endpoint of mean score in MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E
time frame: 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
time frame: 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
time frame: Day 90

Secondary Outcomes

Measure
Mortality
time frame: Day 10
Mortality
time frame: Day 30
Mortality
time frame: 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
time frame: Day 180
Mortality
time frame: Day 180

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title A Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin in Patients With Traumatic Brain Injury
Principal investigator Wai S Poon, Prof.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Ever Neuro Pharma GmbH.