Early IV BXOS110 versus placebo for acute ischaemic stroke within 3 hours

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicentre, randomized, double-blind, placebo-controlled Phase III trial comparing a single dose of BXOS110 (3.0 mg/kg, max 300 mg) to placebo in adults with acute ischaemic stroke. Each arm enrolls 556 participants who meet inclusion criteria, including NIHSS 8–25 and limb weakness, and who can start treatment within 3 hours of symptom onset. Patients are randomized 1:1, receive IV administration, and are evaluated immediately after dosing and at Day 2, Day 3, Day 10 or discharge, Day 30, and Day 90 for efficacy and safety outcomes. The design aims to clarify the efficacy and safety of early BXOS110 administration in reducing overall disability after stroke.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age18\~85 (including 18 and 85 years)，no gender limitation;
2. Subjects diagnosed with acute ischaemic stroke according to the Chinese Guidelines for Clinical Management of Cerebrovascular Disease (2nd edition);
3. 8 ≤ NIHSS score ≤ 25 before randomisation，and the sum of the score of the 5th upper limb and the 6th lower limb was ≥ 2 ;
4. Within 3h of stroke onset and expected to be able to start receiving the investigational product within 3 h of stroke onset (note: stroke onset time was calculated from the onset time of stroke symptoms; if stroke onset occurs during sleep, the stroke onset time should be taken as the latest normal appearance time);
5. First stroke onset, or have a history of stroke but good prognosis (mRS score ≤1);
6. Subjects who are able to understand and comply with the study procedures, and who agree to sign the study informed consent form in writing to indicate that they are willing to participate in the trial (the informed consent form can be signed by subjects or their legal representatives).

Exclusion Criteria:

1. Imaging confirmed intracranial hemorrhagic disease (hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, traumatic cerebral hemorrhage, etc.);
2. Severe disturbance of consciousness: NIHSS 1a score ≥2 points;
3. After aggressive antihypertensive therapy, hypertension still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥110 mmHg;
4. Severe hyperglycemia/hypoglycemia: blood glucose≥400 mg/dL (22.2 mmol/L), or ≤50 mg/dL (2.8 mmol/L);
5. Heart rate \< 50 beats /min or heart rate \> 120 beats /min; Heart failure, unstable angina pectoris, acute myocardial infarction, and severe arrhythmias within the previous 6 months;
6. Previously diagnosed severe hepatic and renal dysfunction and determined by the investigators as affect the subjects;
7. Patients who have suffered from malignant tumors or are undergoing anti-tumor treatment within the past 5 years;
8. Patients who have been treated with neuroprotective agents after current stoke onset;
9. Have a epilepsy history or have epilepsy symptoms after current stoke onset;
10. Combined with other mental illnesses, resulting in inability or unwillingness to cooperate;
11. Combined with claudication, osteoarthropathy, etc., resulting in limb movement dysfunction, which is determined by investigators to affect neurological function test;
12. History of severe head trauma or stroke within 3 months before screening;
13. History of severe food or drug allergy, or known allergy to the investigational drug and its excipients;
14. Expected survival period is less than 3 months;
15. Pregnant, planning pregnancy or breastfeeding patients;
16. Suspected or confirmed history of alcohol or drug abuse;
17. Participated in other drug or device clinical trial within the 1 months prior to screening or are participating in a other clinical trial;
18. Other conditions, and the investigator assessed that participation in the study might increase the patient's risk or that participation in the study was deemed inappropriate by the investigator.

Where it's running

• Harrison International Peace Hospital
  Hengshui, Hebei, China Recruiting
• Daqing Oilfield General Hospital
  Daqing, Heilongjiang, China Recruiting
• The First Affiliated Hospital of Nanyang Medicinal College
  Nanyang, Henan, China Recruiting
• MeiHekou Central Hospital
  Meihekou, Jilin, China Recruiting
• The Affiliated Hospital of Shenyang Medical College
  Shenyang, Liaoning, China Recruiting
• Xianyang Hospital of Yan'an University
  Xianyang, Shaanxi, China Recruiting

Study contacts

• Study coordinator: ming xiao zhang
• Email: zhangxiaoming@biocells.cn
• Phone: +86 15910367860

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.