Intracerebral HemorrhagePhase 4CLINCHNCT06899464
Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage - a Prospective Randomized Open Blinded End-point Trial
A Phase 4 study testing 14-day Cerebrolysin treatment in people with Intracerebral Hemorrhage and Hemorrhagic Stroke, Intracerebral, run by Cardinal Stefan Wyszynski University.
Trial summary
This study is designed to determine the safety and feasibility of using Cerebrolysin in treating primary intracerebral hemorrhage (ICH). This is a multicenter, prospective, randomized, open-label, blinded end-point, phase IV parallel group study done in specialized stroke treatment centers in Poland. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage, Hemorrhagic Stroke, Intracerebral, Hemorrhagic Stroke
- What is being tested?
- 14-day Cerebrolysin treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- NIHSS ≥8 at randomization
- Stroke onset <6h
- Pre-randomization head CT demonstrating an acute, primary lobar ICH
- ICH volume 30 to 80 mL
- Glasgow Coma Score (GCS) 5 to 12
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- Pre-stroke independence (modified Rankin Score 0 to 2)
- Ability to provide informed consent
- No history of prior stroke
Who cannot join
- Hemorrhage caused by head trauma
- Medical history or neuroimaging findings suggestive of ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct
- Bilateral fixed dilated pupils
- Extensor motor posturing
- Intraventricular extension of the hemorrhage is visually estimated to involve >50% of either of the lateral ventricles
- Primary Thalamic and basal ganglia ICH
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- Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar
- Current use of low molecular weight heparins in therapeutic dose
- Evidence of active bleeding
- Uncorrected coagulopathy or known clotting disorder
- Platelet count < 75,000, International Normalized Ratio (INR) > 1.4 after correction
- End stage renal disease
- Patients with a mechanical heart valve
- End-stage liver disease
- Epilepsy with grand mal seizures
- History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or post-menopausal
- Known life-expectancy of less than 6 months
- No reasonable expectation of recovery, Do-Not-Resuscitate (DNR), or comfort measures only prior to randomization
- Participation in a concurrent interventional medical investigation or clinical trial
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent
- Any condition that would represent a contraindication for cerebrolysin administration
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Kinga Rutkowska, M.Sc.Pharm. contact
About this study
Official title: Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage
This study is designed to determine the safety and feasibility of using Cerebrolysin in treating primary intracerebral hemorrhage (ICH).
This is a multicenter, prospective, randomized, open-label, blinded end-point, phase IV parallel group study done in specialized stroke treatment centers in Poland. The study objective is to evaluate if a 14-day cerebrolysin treatment initiated within 6 hours of onset of primary lobar hemorrhage in addition to the standard of care that includes early intensive rehabilitation is safe and feasible, affects hematoma growth and improves the outcome.
Read more
This study is designed to assess the early effect of using Cerebrolysin in patients after ICH, therefore 3 months of follow-up has been chosen. Patients will receive 50 ml of Cerebrolysin once daily until day 14. Subjects will be evaluated on Day 1 (baseline), Day 2, Day 7, Day 30 and Day 90.
Enrollment to the study is expected to reach 30 subjects in 12 months. The study should be completed within 15 months (the end of study).
The primary outcome measure will be change from baseline in functional independence (mRS 0-2) at Day 90 following stroke onset. The safety outcome will be the number of serious adverse events until Day 30.
- Being tested
- 14-day Cerebrolysin treatment, Standard of Care (SOC)
- Keywords
- Cerebrolysin in stroke, neuroprotection in stroke, Cerebrolysin in hemorrhagic stroke
- Medical subject headings
- Cerebral Hemorrhage, Hemorrhagic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14-day Cerebrolysin treatmentDrug
14-day cerebrolysin treatment initiated within 6 hours of onset of stroke
Standard of Care (SOC)Other
Standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| Cerebrolysin | Experimental | Cerebrolysin infusion (50 ml mixed with 250 mL of saline) will be initiated as soon as possible and within 6 hours of stroke onset. Cerebrolysin treatment will be continued (50 ml/d) once daily until day 14. Receives: Drug: 14-day Cerebrolysin treatment |
| Placebo | Placebo comparator | Standard of care Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Outcome
Change from baseline in functional independence (mRS 0-2) at Day 90 following stroke onset
Measured: 90 days from stroke onset
Safety Outcome
Number of Serious Adverse Events until Day 30
Measured: 30 days from stroke onset
Secondary outcomes (5)
Neurological deficit
Change from baseline in neurological deficit measured by NIHSS at Day 2, 7, 30, and 90
Measured: Day 2, 7, 30, and 90 from stroke onset
Functional independence
Change from baseline in improving functional independence (mRS 0-2) at Day 30
Measured: 30 days from stroke onset
Activities of daily living
Change from baseline in activities of daily living (by BartheI Index) on Day 30 and 90
Measured: 30 and 90 days from stroke onset
Hematoma growth
Hematoma growth from Day 1 to Day 2
Measured: 2 days from stroke onset
Mortality
Mortality rate on Day 90
Measured: 90 days from stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardinal Stefan Wyszynski University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Kobayashi, Cardinal Stefan Wyszynski University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899464
- Sponsor's protocol ID
- 000101
- Acronym
- CLINCH
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06899464
- Acronym / sponsor ID
- CLINCH / 000101
- Keywords
- Cerebrolysin in stroke, neuroprotection in stroke, Cerebrolysin in hemorrhagic stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cardinal Stefan Wyszynski UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 28 Mar 2025 (actual)
- 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.
This study is designed to determine the safety and feasibility of using Cerebrolysin in treating primary intracerebral hemorrhage (ICH).
This is a multicenter, prospective, randomized, open-label, blinded end-point, phase IV parallel group study done in specialized stroke treatment centers in Poland. The study objective is to evaluate if a 14-day cerebrolysin treatment initiated within 6 hours of onset of primary lobar hemorrhage in addition to the standard of care that includes early intensive rehabilitation is safe and feasible, affects hematoma growth and improves the outcome.
This study is designed to assess the early effect of using Cerebrolysin in patients after ICH, therefore 3 months of follow-up has been chosen. Patients will receive 50 ml of Cerebrolysin once daily until day 14. Subjects will be evaluated on Day 1 (baseline), Day 2, Day 7, Day 30 and Day 90.
Enrollment to the study is expected to reach 30 subjects in 12 months. The study should be completed within 15 months (the end of study).
The primary outcome measure will be change from baseline in functional independence (mRS 0-2) at Day 90 following stroke onset. The safety outcome will be the number of serious adverse events until Day 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebrolysin | Experimental | Drug: 14-day Cerebrolysin treatmentCerebrolysin infusion (50 ml mixed with 250 mL of saline) will be initiated as soon as possible and within 6 hours of stroke onset. Cerebrolysin treatment will be continued (50 ml/d) once daily until day 14. |
| Placebo | Placebo comparator | Other: Standard of Care (SOC)Standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-80 years
- NIHSS ≥8 at randomization
- Stroke onset <6h
- Pre-randomization head CT demonstrating an acute, primary lobar ICH
- ICH volume 30 to 80 mL
Key exclusion criteria (22 listed)
- Hemorrhage caused by head trauma
- Medical history or neuroimaging findings suggestive of ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct
- Bilateral fixed dilated pupils
- Extensor motor posturing
- Intraventricular extension of the hemorrhage is visually estimated to involve >50% of either of the lateral ventricles
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 |
|---|---|---|
| 14-day Cerebrolysin treatment14-day cerebrolysin treatment initiated within 6 hours of onset of stroke | Drug | Cerebrolysin |
| Standard of Care (SOC)Standard of care treatment | Other | Placebo |
Primary outcome
Efficacy Outcome
Time frame: 90 days from stroke onset
Change from baseline in functional independence (mRS 0-2) at Day 90 following stroke onset
Safety Outcome
Time frame: 30 days from stroke onset
Number of Serious Adverse Events until Day 30
5 secondary outcomes
Neurological deficit
Time frame: Day 2, 7, 30, and 90 from stroke onset
Functional independence
Time frame: 30 days from stroke onset
Activities of daily living
Time frame: 30 and 90 days from stroke onset
Hematoma growth
Time frame: 2 days from stroke onset
Mortality
Time frame: 90 days from stroke onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
Kinga Rutkowska, M.Sc.Pharm. contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 14-day Cerebrolysin treatment in people with Intracerebral Hemorrhage and Hemorrhagic Stroke, Intracerebral, run by Cardinal Stefan Wyszynski University.
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 9 inclusion and 22 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: opening soon, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Kobayashi, M.D. Ph.D. (+48602266498, a.kobayashi@uksw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Outcome (time frame: 90 days from stroke onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2025.