NCT06899464

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

Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cardinal Stefan Wyszynski University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Intracerebral Hemorrhage
• Hemorrhagic Stroke, Intracerebral
• Hemorrhagic Stroke
• Stroke

Interventions

Type	Name	Description
DRUG	14-day Cerebrolysin treatment	14-day cerebrolysin treatment initiated within 6 hours of onset of stroke
OTHER	Standard of Care (SOC)	Standard of care treatment

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-01-01
• Completion: 2027-04-01
• First posted: 2025-03-28
• Last updated: 2025-03-28