Last updated: July 11, 2023
Sponsor: Simcere Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting
Phase
2
Condition
Stroke
Brain Injury
Hemorrhage
Treatment
Synbixin/Placebo
Clinical Study ID
NCT05953103
SIM0355-201
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 MedicalAssociation Neurology Score issued by the "Key Points in the Diagnosis of VariousMajor 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 24hours (subjects who sign the informed consent form should receive study treatment assoon as possible, some subjects meet the criteria during the screening period, morethan 24 hours when starting study treatment, this patient should terminate the studytreatment);
- mRS score of 0 or 1 before onset.
Exclusion
Exclusion Criteria:
- allergic to edaravone, dextromethorphan or contained excipients;
- stroke within the past 3 months;
- other concomitant sites of hematoma volume > 5ml, or the need for external ventriculardrainage of patients with intraventricular hemorrhage;
- patients with obstructive hydrocephalus;
- drugs, vascular structural damage or coagulation disorders caused by cerebralhemorrhage;
- vital signs unstable, suspected cerebral hernia, deep coma or anisocoria and othercritical manifestations;
- after this onset has been applied edaravone or dextromethorphan components (such asedaravone injection, Angong Niuhuang pills, Xingnaojing, etc.) of drugs, or hasapplied a total of more than 2 times the daily recommended dose of the instructions ofthe following drugs: citicoline, oxiracetam, piracetam, ulinastatin;
- planned surgical evacuation of hematoma, including: craniotomy hematoma evacuation,minimally invasive surgery and decompressive craniectomy;
- ALT or AST > 2.0 × ULN or previously known liver disease, such as acute hepatitis,chronic active hepatitis, cirrhosis, etc., previously known kidney disease, renalinsufficiency, serum creatinine > 1.5 × ULN or creatinine clearance < 50 mL/min;
- Suffering from other bleeding disorders, such as thrombocytopenic purpura, bleedingtendency caused by vascular injury, hemophilia and other coagulation disorders,gastrointestinal ulcers, urinary tract bleeding, hemoptysis, etc.;
- Presence of severe, progressive, or uncontrolled symptoms of renal, hepatic,hematological, gastrointestinal, pulmonary, cardiovascular, neurological, or cerebraldisease that, in the opinion of the investigator, place the subject at unacceptablerisk by participating in this study;
- With severe active bacterial or viral infection;
- Concurrent malignancy or ongoing anti-tumor therapy;
- With severe systemic disease, expected survival < 90 days;
- Patients with severe mental disorders and dementia;
- Patients who are pregnant, lactating and planning pregnancy;
- Reasons for other investigators' unsuitability to participate in this trial.
Study Design
Total Participants: 380
Treatment Group(s): 1
Primary Treatment: Synbixin/Placebo
Phase: 2
Study Start date:
July 03, 2023
Estimated Completion Date:
June 30, 2025
Study Description
Connect with a study center
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510080
ChinaActive - Recruiting

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