search
Back to results

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

Primary Purpose

Traumatic Brain Injury

Status
Terminated
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Cerebrolysin
0.9% NaCl, saline
Sponsored by
Ever Neuro Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

0.9% NaCl, saline

Cerebrolysin

Arm Description

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Mortality
Mortality
Mortality
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
Mortality

Full Information

First Posted
May 21, 2012
Last Updated
February 24, 2020
Sponsor
Ever Neuro Pharma GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT01606111
Brief Title
The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery
Acronym
CAPTAIN
Official Title
A Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin in Patients With Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Poor patient recruitment
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ever Neuro Pharma GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.9% NaCl, saline
Arm Type
Placebo Comparator
Arm Title
Cerebrolysin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cerebrolysin
Other Intervention Name(s)
Cognicer, Renacenz
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
0.9% NaCl, saline
Other Intervention Name(s)
Saline
Intervention Description
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 Outcome Measure Information:
Title
Composite endpoint of mean score in MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E
Description
Global status is assessed by an ensemble of appropriate, single efficacy criteria to be tested by a multivariate, directional test approach
Time Frame
Day 10
Title
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
Title
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 Outcome Measure Information:
Title
Mortality
Time Frame
Day 10
Title
Mortality
Time Frame
Day 30
Title
Mortality
Time Frame
Day 90
Title
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
Title
Mortality
Time Frame
Day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai S Poon, Prof.
Organizational Affiliation
Prince of Wales Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
31494820
Citation
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. Erratum In: Neurol Sci. 2020 Jan 6;:
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs