Traumatic Brain InjuryPhase 4CAPTAINNCT01606111
The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery
A Phase 4 study testing Cerebrolysin and 0.9% NaCl, saline in people with Traumatic Brain Injury, run by Ever Neuro Pharma GmbH at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Cerebrolysin and 0.9% NaCl, saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2013to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Penetrating high-velocity missile head trauma
- Stab wound trauma into the brain
- Patients with spinal cord injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin in Patients With Traumatic Brain Injury
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Cerebrolysin, 0.9% NaCl, saline
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinDrug
Also called 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)
0.9% NaCl, salineDrug
Also called 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)
| Study group | Role | What they receive |
|---|---|---|
| 0.9% NaCl, saline | Placebo comparator | Not described Receives: Drug: 0.9% NaCl, saline |
| Cerebrolysin | Experimental | Not described Receives: Drug: Cerebrolysin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Day 90
Secondary outcomes (5)
Mortality
Measured: Day 10
Mortality
Measured: Day 30
Mortality
Measured: 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
Measured: Day 180
Mortality
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startSep 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Poor patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ever Neuro Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wai S Poon, Prof., Principal investigator, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606111
- Sponsor's protocol ID
- EVE-CN-0610
- Acronym
- CAPTAIN
- Status last verified
- Feb 2020
- First submitted
- 21 May 2012
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31494820
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin in Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01606111
- Acronym / sponsor ID
- CAPTAIN / EVE-CN-0610
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor patient recruitment
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ever Neuro Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.9% NaCl, saline | Placebo comparator | Drug: 0.9% NaCl, saline |
| Cerebrolysin | Experimental | Drug: Cerebrolysin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Clinical diagnosis of TBI and a GCS 7-12
- Only isolated TBI
- CT
- Pre-Trauma Karnofsky-Index = 100
- Age 18-60 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CerebrolysinAlso: Cognicer, RenacenzIV 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) | Drug | Cerebrolysin |
| 0.9% NaCl, salineAlso: SalineIV 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) | Drug | 0.9% NaCl, saline |
Primary outcome
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 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
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Poor patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Results publication: PubMed 31494820Poon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai S Poon, Prof. principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cerebrolysin and 0.9% NaCl, saline in people with Traumatic Brain Injury, run by Ever Neuro Pharma GmbH at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of mean score in MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E (time frame: Day 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01606111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.