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

NCT ID: NCT05953103

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-03
• Study Completion Date: 2025-06-30

Brief 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 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).

Detailed Description

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). Safety was assessed unblinding after the end of study treatment for all subjects in the first dose level group and escalated to the second dose level if the "safe dose" criterion was met, otherwise the trial was terminated; safety was assessed unblinding after the end of study treatment for all subjects in the second dose level group and the 62.5 mg dose level was selected to enter Stage B if the "safe dose" criterion was met, otherwise the 37.5 mg dose level was selected to enter Stage B.

Conditions

Subjects With Cerebral Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A 1 - Subjects with cerebral hemorrhage (Synbixin 37.5 mg; placebo group )

Group Type: EXPERIMENTAL

Synbixin/Placebo

Intervention Type: DRUG

Synbixin/Placebo

Part A 2 - Subjects with cerebral hemorrhage ( Synbixin 62.5 mg; placebo group )

Group Type: EXPERIMENTAL

Synbixin/Placebo

Intervention Type: DRUG

Synbixin/Placebo

Part B - Subjects with cerebral hemorrhage ( Synbixin TBD mg; placebo group )

Group Type: EXPERIMENTAL

Synbixin/Placebo

Intervention Type: DRUG

Synbixin/Placebo

Interventions

Synbixin/Placebo

Synbixin/Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. the subject himself or her legal representative has signed the informed consent form;

2. aged ≥ 18 years and ≤ 80 years, male or female;

3. 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];

4. the bleeding center site is located in the basal ganglia;

5. intracranial hematoma volume ≤ 30 ml;

6. NIHSS score at enrollment total score ≥ 6 points and ≤ 20 points, and the sum of items 5 and 6 ≥ 2 points;

7. coma degree is mild to moderate, Glasgow Coma Scale (GCS) ≥ 9 points;

8. 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);

9. mRS score of 0 or 1 before onset.

Exclusion Criteria

1. allergic to edaravone, dextromethorphan or contained excipients;

2. stroke within the past 3 months;

3. other concomitant sites of hematoma volume > 5ml, or the need for external ventricular drainage of patients with intraventricular hemorrhage;

4. patients with obstructive hydrocephalus;

5. drugs, vascular structural damage or coagulation disorders caused by cerebral hemorrhage;

6. vital signs unstable, suspected cerebral hernia, deep coma or anisocoria and other critical manifestations;

7. after this onset has been applied edaravone or dextromethorphan components (such as edaravone injection, Angong Niuhuang pills, Xingnaojing, etc.) of drugs, or has applied a total of more than 2 times the daily recommended dose of the instructions of the following drugs: citicoline, oxiracetam, piracetam, ulinastatin;

8. planned surgical evacuation of hematoma, including: craniotomy hematoma evacuation, minimally invasive surgery and decompressive craniectomy;

9. ALT or AST > 2.0 × ULN or previously known liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc., previously known kidney disease, renal insufficiency, serum creatinine > 1.5 × ULN or creatinine clearance < 50 mL/min;

10. Suffering from other bleeding disorders, such as thrombocytopenic purpura, bleeding tendency caused by vascular injury, hemophilia and other coagulation disorders, gastrointestinal ulcers, urinary tract bleeding, hemoptysis, etc.;

11. Presence of severe, progressive, or uncontrolled symptoms of renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, or cerebral disease that, in the opinion of the investigator, place the subject at unacceptable risk by participating in this study;

12. With severe active bacterial or viral infection;

13. Concurrent malignancy or ongoing anti-tumor therapy;

14. With severe systemic disease, expected survival < 90 days;

15. Patients with severe mental disorders and dementia;

16. Patients who are pregnant, lactating and planning pregnancy;

17. Reasons for other investigators' unsuitability to participate in this trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Simcere Pharmaceutical Co., Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaonan Yao

Role: STUDY_DIRECTOR

Simcere Pharmaceutical Co., Ltd

Locations

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Wang

Role: CONTACT

wangyi4@simcere.com

15805160455

Facility Contacts

Jinsheng Zeng, Doctor

Role: primary

zengjs@pub.guangzhou.gd.cn

020-87755766-8293

Other Identifiers

SIM0355-201

Identifier Type: -

Identifier Source: org_study_id