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

NCT05953103 | Unknown Phase 2

• 1 other identifier: SIM0355-201
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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).

Conditions

Subjects With Cerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

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

  up to 90 days after the first dose of treatment

Secondary Outcomes (16)

• Incidence of deaths up to 90 days after the first dose of treatment

  up to 90 days after the first dose of treatment

• Proportion of subjects with AEs, AEs leading to dose interruption or discontinuation, AEs related to study drug, AEs of special interest (AESls), and with abnormal vital signs, abnormal physical examination findings and abnormal laboratory tests results

  up to 90 days after the first dose of treatment

• Proportion of subjects with modified Rankin Score (mRS) 0-2, which assesses the degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms) to 6 (death), at 90 days after the first dose of treatment

  at 90 days after the first dose of treatment

• Proportion of subjects with modified Rankin Score (mRS) 0-1, which assesses the degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms) to 6 (death), at 90 days after the first dose of treatment

  at 90 days after the first dose of treatment

• Distribution of subjects with modified Rankin Score (mRS), which assesses the degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms) to 6 (death), at 14, 30, 90 days after the first dose of treatment

  at 14, 30, 90 days after the first dose of treatment

Study Arms (3)

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

EXPERIMENTAL

Drug: Synbixin/Placebo

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

EXPERIMENTAL

Drug: Synbixin/Placebo

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

EXPERIMENTAL

Drug: Synbixin/Placebo

Interventions

Synbixin/Placebo DRUG

Synbixin/Placebo

Part A 1 - Subjects with cerebral hemorrhage (Synbixin 37.5 mg; placebo group ); Part A 2 - Subjects with cerebral hemorrhage ( Synbixin 62.5 mg; placebo group ); Part B - Subjects with cerebral hemorrhage ( Synbixin TBD mg; placebo group )

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• mRS score of 0 or 1 before onset.

You may not qualify if:

• 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 ventricular drainage of patients with intraventricular hemorrhage;
• patients with obstructive hydrocephalus;
• drugs, vascular structural damage or coagulation disorders caused by cerebral hemorrhage;
• vital signs unstable, suspected cerebral hernia, deep coma or anisocoria and other critical manifestations;
• 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;
• 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, renal insufficiency, serum creatinine \> 1.5 × ULN or creatinine clearance \< 50 mL/min;
• 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.;
• 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;
• 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;

Sponsors & Collaborators

• Simcere Pharmaceutical Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Study Officials

• Xiaonan Yao

  Simcere Pharmaceutical Co., Ltd

  STUDY DIRECTOR

Central Study Contacts

Yi Wang

CONTACT

15805160455; wangyi4@simcere.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 19, 2023
• Study Start: July 3, 2023
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: July 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)