NCT01606111

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

May 21, 2012

Last Update Submit

February 24, 2020

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (5)

  • Mortality

    Day 10

  • Mortality

    Day 30

  • Mortality

    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

    Day 180

  • Mortality

    Day 180

Study Arms (2)

0.9% NaCl, saline

PLACEBO COMPARATOR
Drug: 0.9% NaCl, saline

Cerebrolysin

EXPERIMENTAL
Drug: Cerebrolysin

Interventions

CerebrolysinDRUG

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)

Also known as: Cognicer, Renacenz
Cerebrolysin
0.9% NaCl, salineDRUG

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)

Also known as: Saline
0.9% NaCl, saline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Poon W, Matula C, Vos PE, Muresanu DF, von Steinbuchel N, von Wild K, Homberg 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, Asian-Pacific trial. Neurol Sci. 2020 Feb;41(2):281-293. doi: 10.1007/s10072-019-04053-5. Epub 2019 Sep 7.

    PMID: 31494820RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

cerebrolysinSodium Chloride

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Wai S Poon, Prof.

    Prince of Wales Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 25, 2012

Study Start

September 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

HK(1)