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

Ever Neuro Pharma GmbH1 site in 1 country46 target enrollmentSeptember 2013

ConditionsTraumatic Brain Injury

Interventions0.9% NaCl, saline Cerebrolysin

DrugsCerebrolysin 0.9% NaCl, saline

Overview

Phase: Phase 4
Intervention: 0.9% NaCl, saline
Conditions: Traumatic Brain Injury
Sponsor: Ever Neuro Pharma GmbH
Enrollment: 46
Locations: 1
Primary Endpoint: Composite endpoint of mean score in MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

July 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ever Neuro Pharma GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinical diagnosis of TBI and a GCS 7-12
•Only isolated TBI
•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

Arms & Interventions

0.9% NaCl, saline

Intervention: 0.9% NaCl, saline

Cerebrolysin

Intervention: Cerebrolysin

Outcomes

Primary Outcomes

Composite endpoint of mean score in MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E

Time Frame: Day 10

Global status is assessed by an ensemble of appropriate, single efficacy criteria to be tested by a multivariate, directional test approach

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

Mortality(Day 180)
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)