Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage - a Prospective Randomized Open Blinded End-point Trial (CLINCH)

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Stroke; Hemorrhagic Stroke; Intracerebral Hemorrhage; Hemorrhagic Stroke, Intracerebral
• Intervention / Treatment: Drug: 14-day Cerebrolysin treatment; Other: Standard of Care (SOC)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Adam Kobayashi, M.D. Ph.D.; Phone Number: +48602266498; Email: a.kobayashi@uksw.edu.pl
• Study Contact Backup: Name: Kinga Rutkowska, M.Sc.Pharm.; Email: kinga.rutkowska@uksw.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Pre-stroke independence (modified Rankin Score 0 to 2)
• Ability to provide informed consent
• No history of prior stroke

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cerebrolysin; 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.	Drug: 14-day Cerebrolysin treatment; 14-day cerebrolysin treatment initiated within 6 hours of onset of stroke
Placebo Comparator: Placebo; Standard of care	Other: Standard of Care (SOC); Standard of care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Outcome	Change from baseline in functional independence (mRS 0-2) at Day 90 following stroke onset	90 days from stroke onset
Safety Outcome	Number of Serious Adverse Events until Day 30	30 days from stroke onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological deficit	Change from baseline in neurological deficit measured by NIHSS at Day 2, 7, 30, and 90	Day 2, 7, 30, and 90 from stroke onset
Functional independence	Change from baseline in improving functional independence (mRS 0-2) at Day 30	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	30 and 90 days from stroke onset
Hematoma growth	Hematoma growth from Day 1 to Day 2	2 days from stroke onset
Mortality	Mortality rate on Day 90	90 days from stroke onset

Collaborators and Investigators

• Sponsor: Cardinal Stefan Wyszynski University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 21, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Cerebrolysin in stroke; neuroprotection in stroke; Cerebrolysin in hemorrhagic stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Intracranial Hemorrhages; Hemorrhagic Stroke; Stroke; Hemorrhage; Cerebral Hemorrhage; Physiological Effects of Drugs; Protective Agents; Neuroprotective Agents; Nootropic Agents; Cerebrolysin
• Other Study ID Numbers: 000101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No