A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 24
- 主要终点
- Proportion of subjects with mRS score 0-2 on day 90
研究概览
简要总结
The purpose of this study was to evaluate the effectiveness of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke.
详细描述
This trial was conducted in a multicentre, randomised, double-blind, placebo-parallel controlled design, with a total of three groups of 100 subjects in each of the three planned groups, namely, the BXOS110 high-dose group (3.0 mg/kg, with a maximum dose of up to 300 mg), the BXOS110 low-dose group (2.0 mg/kg, with a maximum dose of up to 200 mg) and the placebo-control group, with the aim of exploring the efficacy and safety of BXOS110 at different doses of BXOS110. efficacy and safety of BXOS110.
The trial was divided into a screening/baseline period, a treatment period and a follow-up period. In the screening/baseline phase, patients signed an informed consent form within 3 hours of stroke onset to enter the trial, and after completing the screening and procedures related to the trial, subjects who met the enrolment requirements were randomly assigned to the BXOS110 high-dose group, the BXOS110 low-dose group, or a placebo-controlled group in a ratio of 1: 1: 1. During the treatment phase, subjects were randomly grouped into groups to start the intravenous treatment, and evaluations were carried out immediately after the administration of BXOS110. immediately after administration; during the Follow-up Period, subjects were evaluated for effectiveness and safety on Day 2, Day 3, Day 10, or at discharge (whichever occurred earlier), Day 30, and Day 90 after administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age18~85 (including 18 and 85 years)，no gender limitation;
- •Subjects diagnosed with acute ischaemic stroke according to the Chinese Guidelines for Clinical Management of Cerebrovascular Disease (2nd edition);
- •6 ≤ NIHSS score ≤ 20 before randomisation;
- •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);
- •First stroke onset, or have a history of stroke but good prognosis (mRS score ≤1);
- •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).
排除标准
- •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 < 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, as determined by the investigators to be severe heart disease, affected participants;
- •Previously diagnosed severe hepatic and renal dysfunction and determined by the investigators as affect the subjects;
- •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 3 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.
研究组 & 干预措施
BXOS110 high-dose group
Name:BXOS110 Dosage form:injection Dosage:3.0 mg/kg, maximum dose not exceeding 300 mg Frequency:Frequency of injection is once Duration:10±1 min
干预措施: high-dose BXOS110 (Drug)
BXOS110 low-dose group
Name:BXOS110 Dosage form:injection Dosage:2.0 mg/kg, maximum dose not exceeding 300 mg Frequency:Frequency of injection is once Duration:10±1 min
干预措施: low-dose BXOS110 (Drug)
Placebo control group
Dosage:0 mg/kg Frequency:Frequency of injection is once Duration:10±1 min
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects with mRS score 0-2 on day 90
时间窗: Day 90
Modified Rankin scale The Rankin scale was devised in 1957 for assessment of stroke outcomes, and was modified in 1988 to improve its comprehensiveness.The modified version, or mRS, has since been commonly used to assess disability after a stroke. The mRS attempts to measure functional independence, incorporating the WHO components of body function, activity, and participation. The scale is defined categorically with seven different grades: 0 indicates no symptoms, 5 indicates severe disability, and 6 indicates death. A 1-point shift on this scale is often deemed clinically significant because of the large category sizes. Patients may use adaptive devices and still be considered independent, but the need for supervision or even minimum aid from another person is scored as dependent.
次要结局
- Proportion of subjects with NIHSS scores ≤1 on day 10 (or at discharge)(Day 10)
- Proportion of subjects with mRS score 0-1 on day 90(Day 90)
- Day 90 mRS Displacement Analysis(Day 90)
- Proportion of subjects with Barthel Index Scale (BI) scores ≥95 on day 90(Day 90)
- Proportion of subjects with a ≥4-point reduction in NIHSS score from baseline at day 10 (or at discharge)(D10)
- Day 90 European Five Dimensional Health Scale (EQ-5D) Score(Day 90)
- Change in infarct volume from baseline after 24 hours of dosing(24 hours after treatment)
- Proportion of subjects with ≥4 point increase in NIHSS score during hospitalisation(D1~ Day 10)
- Mortality due to stroke within 90 days(Day 90)