TerminatedPhase 2

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

Stopped: This study was terminated after completing the first dose level of Sanbenxin 37.5 mg due to the decision made by the sponsor that a new clinical development program for the new form of sublingual tablets would replace the existing plan.

China80 participantsStarted 2023-07-03

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. the subject himself or her legal representative has signed the informed consent form;
✓. aged ≥ 18 years and ≤ 80 years, male or female;
✓. clinical diagnosis of cerebral hemorrhage, in line with the Chinese Medical Association Neurology Score issued by the "Key Points in the Diagnosis of Various Major Cerebrovascular Diseases in China 2019" cerebral hemorrhage diagnostic criteria \[1\];
✓. the bleeding center site is located in the basal ganglia;
✓. intracranial hematoma volume ≤ 30 ml;
✓. NIHSS score at enrollment total score ≥ 6 points and ≤ 20 points, and the sum of items 5 and 6 ≥ 2 points;
✓. coma degree is mild to moderate, Glasgow Coma Scale (GCS) ≥ 9 points;
✓. the time from the onset of this stroke to the start of study treatment is 6 to 24 hours (subjects who sign the informed consent form should receive study treatment as soon as possible, some subjects meet the criteria during the screening period, more than 24 hours when starting study treatment, this patient should terminate the study treatment);

Exclusion criteria

What they're measuring

Incidence of serious adverse events (SAEs) up to 90 days after the first dose of treatment

Timeframe: up to 90 days after the first dose of treatment

Trial details

NCT IDNCT05953103

SponsorSimcere Pharmaceutical Co., Ltd

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-02

View on ClinicalTrials.gov More Subjects With Cerebral Hemorrhage trials