BXOS110 Injection in the Treatment of Acute Ischaemic Stroke
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
1 other identifier
interventional
300
1 country
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2024
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 7, 2024
CompletedFirst Submitted
Initial submission to the registry
March 12, 2024
CompletedFirst Posted
Study publicly available on registry
March 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedMarch 21, 2024
March 1, 2024
1.1 years
March 12, 2024
March 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects with mRS score 0-2 on 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.
Day 90
Secondary Outcomes (9)
Proportion of subjects with mRS score 0-1 on day 90
Day 90
Day 90 mRS Displacement Analysis
Day 90
Proportion of subjects with NIHSS scores ≤1 on day 10 (or at discharge)
Day 10
Proportion of subjects with a ≥4-point reduction in NIHSS score from baseline at day 10 (or at discharge)
D10
Proportion of subjects with ≥4 point increase in NIHSS score during hospitalisation
D1~ Day 10
- +4 more secondary outcomes
Study Arms (3)
BXOS110 high-dose group
EXPERIMENTALName: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
BXOS110 low-dose group
EXPERIMENTALName: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
Placebo control group
PLACEBO COMPARATORDosage:0 mg/kg Frequency:Frequency of injection is once Duration:10±1 min
Interventions
3.0 mg/kg, maximum dose not exceeding 300 mg，Participants received one administration by intravenous infusion.
2.0 mg/kg, maximum dose not exceeding 200 mg，Participants received one administration by intravenous infusion.
Does not contain any test drug active ingredients，Participants received one administration by intravenous infusion.
Eligibility Criteria
You may qualify if:
- 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);
- ≤ 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).
You may not qualify if:
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Yuebei People's Hospital
Shaoguan, Guangdong, China
Harrison International Peace Hospital
Hengshui, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
Anyang People's Hospital
Anyang, Henan, China
Nanshi Hospital of Nanyang
Nanyang, Henan, China
Nanyang Second General Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Nanyang Medicinal College
Nanyang, Henan, China
MeiHekou Central Hospital
Meihekou, Jilin, China
Beipiao Central Hospital
Chaoyang, Liaoning, China
Ceneral Hospital of Mining Industry Group Fuxin
Fuxin, Liaoning, China
The Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning, China
The First People's Hospital of Shenyang
Shenyang, Liaoning, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
Iron Coal General Hospital of Liaoning Health Industry Group
Tieling, Liaoning, China
Keshketengqi Hospital of Traditional Chinese Medicine and Mongolian Medicine
Chifeng, Neimenggu, China
Xianyang Hospital of Yan'an University
Xianyang, Shaanxi, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Tengzhou Central People's Hospital
Tengzhou, Shandong, China
Sinopharm Tongmei General Hospital
Datong, Shanxi, China
Linfen Central Hospital
Linfen, Shanxi, China
Linfen People's Hospital
Linfen, Shanxi, China
Beijing Tiantan Hospital , Capital Medical University
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2024
First Posted
March 21, 2024
Study Start
February 7, 2024
Primary Completion
March 1, 2025
Study Completion
September 1, 2025
Last Updated
March 21, 2024
Record last verified: 2024-03