Evaluating Edaravone Dexborneol for treating cerebral hemorrhage

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to 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

This study is testing a new injection called Edaravone Dexborneol to see if it can safely help people who have had a cerebral hemorrhage within 6 to 24 hours of their stroke.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Simcere Pharmaceutical Co., Ltd (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05953103 on ClinicalTrials.gov

What this trial studies

This trial is a multicenter, randomized, double-blind, placebo-controlled exploratory clinical trial aimed at assessing the safety and tolerability of different doses of Edaravone Dexborneol concentrate for injection in patients diagnosed with cerebral hemorrhage. Participants must begin treatment within 6 to 24 hours of stroke onset, with specific criteria regarding the location and volume of the hematoma. The trial consists of two periods, focusing on dose escalation to determine the optimal safe dose for further evaluation. Safety assessments will be conducted after treatment to guide the continuation of the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a clinical diagnosis of cerebral hemorrhage and specific criteria regarding hematoma volume and location.

Not a fit: Patients with severe comorbidities or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients suffering from cerebral hemorrhage.

How similar studies have performed: Other studies have explored similar approaches, but the specific combination of Edaravone Dexborneol with conventional therapy in this context is relatively novel.

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.

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Yi Wang

Conditions: Subjects With Cerebral Hemorrhage