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

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2023
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 for injection combined with conventional medical therapy in patients with cerebral hemorrhage. The subject had a clinical diagnosis of cerebral hemorrhage, 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: Synbixin 37.5 mg; placebo group) and the second dose level group (Dose 2 group: Synbixin 62.5 mg; placebo group).
Epistemonikos ID: f932d16109be6e0a551fb67b0a4f2c25eb193431
First added on: May 15, 2024