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

ConditionsIntracerebral HemorrhageHemorrhagic Stroke, IntracerebralHemorrhagic StrokeStroke
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCardinal Stefan Wyszynski University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years

NIHSS ≥8 at randomization

Stroke onset <6h

Pre-randomization head CT demonstrating an acute, primary lobar ICH

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 14-day Cerebrolysin treatment

    Drug

    14-day cerebrolysin treatment initiated within 6 hours of onset of stroke

  • Standard of Care (SOC)

    Other intervention

    Standard of care treatment

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: CerebrolysinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy Outcome

Change from baseline in functional independence (mRS 0-2) at Day 90 following stroke onset

Time frame
90 days from stroke onset
2

Safety Outcome

Number of Serious Adverse Events until Day 30

Time frame
30 days from stroke onset

Secondary outcomes

1

Neurological deficit

Change from baseline in neurological deficit measured by NIHSS at Day 2, 7, 30, and 90

Time frame
Day 2, 7, 30, and 90 from stroke onset
2

Functional independence

Change from baseline in improving functional independence (mRS 0-2) at Day 30

Time frame
30 days from stroke onset
3

Activities of daily living

Change from baseline in activities of daily living (by BartheI Index) on Day 30 and 90

Time frame
30 and 90 days from stroke onset
4

Hematoma growth

Hematoma growth from Day 1 to Day 2

Time frame
2 days from stroke onset

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cardinal Stefan Wyszynski University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: