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Sanbexin IV in Intracerebral Hemorrhage
NCT05953103Phase 2
Key facts
- Status
- Terminated
- Start
- Jul 2023
- Primary completion
- Apr 2025
- Countries
- 1
- Sponsor
- Simcere Pharmaceutical Group
- Modality
- Small Molecules
- Drugs
- edaravone dexborneol
- Conditions
- cerebral hemorrhage
01
Overview
Phase 2, randomised, double-blind trial in cerebral hemorrhage comparing Sanbexin IV with Placebo (2 arms). Primary endpoint: Incidence of serious adverse events at 90 days. Started Jul 2023; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sanbexin IV
Sanbexin IV 37.5 mg (edaravone 30 mg + dexborneol 7.5 mg), intravenous, twice daily, for 14 consecutive days
Placebo
Sanbexin mimetic agent, intravenous, twice daily, for 14 consecutive days
03
Who it enrols
Adult patients aged 18-80 with a clinical diagnosis of cerebral hemorrhage in the basal ganglia, hematoma volume <= 30 ml, NIHSS score 6-20, GCS >= 9, and within 6-24 hours from stroke onset.
04
Endpoints
Primary
Incidence of serious adverse events
Secondary
Incidence of deaths
Proportion of subjects with AEs
Proportion of subjects with modified Rankin Score 0-2
Proportion of subjects with modified Rankin Score 0-1
Distribution of subjects with modified Rankin Score
Distribution of subjects with Glasgow Outcome Score
Change from baseline in National Institutes of Health Stroke Scale
Proportion of subjects with National Institutes of Health Stroke Scale 0-2
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