Evaluate the Efficacy and Safety of Different Doses of Edaravone Dexborneol Concentrated Solution for Injection Combined With Conventional Medical Therapy in the Treatment of Patients With Cerebral Hemorrhage

Summary

The SIM0355-201 trial is a multicenter, randomized, double-blind, placebo-controlled exploratory clinical trial with the main study objective of evaluating the safety and tolerability of different doses of Edaravone Dexborneol concentrate injection (Sanbexin IV) combined with conventional medical therapy in patients with intracerebral hemorrhage (ICH). The subject had a clinical diagnosis of ICH, within 6-24 hours from stroke onset to start of study treatment, with the bleeding site in basal ganglia and a hematoma volume ≤ 30 ml at the bleeding site. The trial was divided into two periods (Period A and Period B), with Period A being a dose escalation period divided into two dose levels: the first dose level group (Dose 1 group: Sanbexin IV 37.5 mg; placebo group) and the second dose level group (Dose 2 group: Sanbexin IV 62.5 mg; placebo group). Period B is the expansion phase, where the sample size is increased based on the optimal dose selected in Phase A to observe efficacy and safety.

Timeline

Start

2023-07-03

Primary completion

2025-04-02

Completion

2025-04-02

Drugs

Indications