Evaluate the Efficacy and Safety of Different Doses of Edaravone Dexborneol Concentrated Solution… (NCT05953103) | Clinical Trial Compass
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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
. 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
. 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;