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Tests treatment safety and results for AIS
Official title A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset.
ClinicalTrials.gov ID: NCT07520565
What this study is testing
What is BXOS110?
BXOS110 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ais.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study was to evaluate the efficacy of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Age18\~85 (including 18 and 85 years)，no gender limitation;
- people diagnosed with acute ischaemic stroke according to the Chinese Guidelines for Clinical Management of Cerebrovascular Disease (2nd edition);
- 8 ≤ NIHSS score ≤ 25 before randomisation，and the sum of the score of the 5th upper limb and the 6th lower limb was ≥ 2 ;
- 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...
- First stroke onset, or have a history of stroke but good prognosis (mRS score ≤1);
You likely can't join if
- Imaging confirmed intracranial hemorrhagic disease (hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage...
- Severe disturbance of consciousness: NIHSS 1a score ≥2 points;
- After aggressive antihypertensive therapy, hypertension still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥110...
- Severe hyperglycemia/hypoglycemia: blood glucose≥400 mg/dL (22.2 mmol/L), or ≤50 mg/dL (2.8 mmol/L);
- Heart rate \ 120 beats /min; Heart failure, unstable angina pectoris, acute myocardial infarction, and severe arrhythmias within the previous 6...
- Previously diagnosed severe hepatic and renal dysfunction and determined by the investigators as affect the people;
See the full eligibility criteria
- Age18\~85 (including 18 and 85 years)，no gender limitation;
- people diagnosed with acute ischaemic stroke according to the Chinese Guidelines for Clinical Management of Cerebrovascular Disease (2nd edition);
- 8 ≤ NIHSS score ≤ 25 before randomisation，and the sum of the score of the 5th upper limb and the 6th lower limb was ≥ 2 ;
- 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...
- First stroke onset, or have a history of stroke but good prognosis (mRS score ≤1);
- people 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...
- Imaging confirmed intracranial hemorrhagic disease (hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, traumatic cerebral hemorrhage, etc.);
- Severe disturbance of consciousness: NIHSS 1a score ≥2 points;
- After aggressive antihypertensive therapy, hypertension still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥110 mmHg;
- Severe hyperglycemia/hypoglycemia: blood glucose≥400 mg/dL (22.2 mmol/L), or ≤50 mg/dL (2.8 mmol/L);
- Heart rate \ 120 beats /min; Heart failure, unstable angina pectoris, acute myocardial infarction, and severe arrhythmias within the previous 6 months;
- Previously diagnosed severe hepatic and renal dysfunction and determined by the investigators as affect the people;
- Patients who have suffered from malignant tumors or are undergoing anti-tumor treatment within the past 5 years;
- Patients who have been treated with neuroprotective agents after current stoke onset;
- Have a epilepsy history or have epilepsy symptoms after current stoke onset;
- Combined with other mental illnesses, resulting in inability or unwillingness to cooperate;
- Combined with claudication, osteoarthropathy, etc., resulting in limb movement dysfunction, which is determined by investigators to affect neurological function test;
- History of severe head trauma or stroke within 3 months before screening;
- History of severe food or drug allergy, or known allergy to the investigational drug and its excipients;
- Expected survival period is less than 3 months;
- Pregnant, planning pregnancy or breastfeeding patients;
- Suspected or confirmed history of alcohol or drug abuse;
- Participated in other drug or device clinical trial within the 1 months prior to screening or are participating in a other clinical trial;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hengshui, Hebei, China
- Daqing, Heilongjiang, China
- Nanyang, Henan, China
- Meihekou, Jilin, China
- Shenyang, Liaoning, China
- Xianyang, Shaanxi, China
- Linyi, Shandong, China
- Linfen, Shanxi, China
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hengshui, Hebei, China; Daqing, Heilongjiang, China; Nanyang, Henan, China; Meihekou, Jilin, China; Shenyang, Liaoning, China; Xianyang, Shaanxi, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.