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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01606111
Other study ID # EVE-CN-0610
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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