BXOS110 Injection in the Treatment of Acute Ischaemic Stroke
- 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.
- Short title
- BXOS110 Injection in the Treatment of Acute Ischaemic Stroke
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-09-01
- First posted
- 2024-03-21
- Registry last updated
- 2024-03-21
- Primary completion date
- 2025-03-01
- Start date
- 2024-02-07
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Biocells (Beijing) Biotech Co.,Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06322394
- ClinicalTrials.gov ID
- NCT06322394
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Proportion of subjects with mRS score 0-2 on day 90
Timeframe: 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.
Proportion of subjects with mRS score 0-1 on day 90
Timeframe: Day 90
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 mRS Displacement Analysis
Timeframe: Day 90
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.
Proportion of subjects with NIHSS scores ≤1 on day 10 (or at discharge)
Timeframe: Day 10
The NIHSS is a 15-item impairment scale, which provides a quantitative measure of key components of a standard neurological examination. The scale assesses level of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect).
Proportion of subjects with a ≥4-point reduction in NIHSS score from baseline at day 10 (or at discharge)
Timeframe: D10
The NIHSS is a 15-item impairment scale, which provides a quantitative measure of key components of a standard neurological examination. The scale assesses level of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect).
Proportion of subjects with ≥4 point increase in NIHSS score during hospitalisation
Timeframe: D1~ Day 10
The NIHSS is a 15-item impairment scale, which provides a quantitative measure of key components of a standard neurological examination. The scale assesses level of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect).
Proportion of subjects with Barthel Index Scale (BI) scores ≥95 on day 90
Timeframe: Day 90
The BI is a scale that measures ten basic aspects of activity related to self-care and mobility. The normal score is 100, and lower scores indicate greater dependency.
Day 90 European Five Dimensional Health Scale (EQ-5D) Score
Timeframe: Day 90
The EQ-5D is a generic HRQoL measurement with evidence of good reliability and validity in various disease populations, including stroke. The EQ-5D contains the self- reported health state profile of five dimensions (mobility, self-care, usual activity, pain/discomfort, and depression/ anxiety) and a visual analog scale (EQ-VAS) .
Mortality due to stroke within 90 days
Timeframe: Day 90
Mortality due to stroke within 90 days
Change in infarct volume from baseline after 24 hours of dosing
Timeframe: 24 hours after treatment
Change in infarct volume from baseline after 24 hours of dosing
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 85 Years
- Healthy volunteers
- No
- 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).
- 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.
- Yuebei People's HospitalShaoguan, ChinaNot yet recruiting
- Harrison International Peace HospitalHengshui, ChinaNot yet recruiting
- The First Hospital of Hebei Medical UniversityShijiazhuang, ChinaNot yet recruiting
- Daqing Oilfield General HospitalDaqing, ChinaNot yet recruiting
- Anyang People's HospitalAnyang, ChinaNot yet recruiting
- Nanshi Hospital of NanyangNanyang, ChinaNot yet recruiting
- Nanyang Second General HospitalNanyang, ChinaNot yet recruiting
- The First Affiliated Hospital of Nanyang Medicinal CollegeNanyang, ChinaNot yet recruiting
- MeiHekou Central HospitalMeihekou, ChinaNot yet recruiting
- Beipiao Central HospitalChaoyang, ChinaRecruiting
- Ceneral Hospital of Mining Industry Group FuxinFuxin, ChinaNot yet recruiting
- The Affiliated Hospital of Shenyang Medical CollegeShenyang, ChinaNot yet recruiting
- The First People's Hospital of ShenyangShenyang, ChinaNot yet recruiting
- The People's Hospital of Liaoning ProvinceShenyang, ChinaNot yet recruiting
- Iron Coal General Hospital of Liaoning Health Industry GroupTieling, ChinaNot yet recruiting
- Keshketengqi Hospital of Traditional Chinese Medicine and Mongolian MedicineChifeng, ChinaRecruiting
- Xianyang Hospital of Yan'an UniversityXianyang, ChinaNot yet recruiting
- Liaocheng People's HospitalLiaocheng, ChinaNot yet recruiting
- Linyi People's HospitalLinyi, ChinaNot yet recruiting
- Tengzhou Central People's HospitalTengzhou, ChinaNot yet recruiting
- Sinopharm Tongmei General HospitalDatong, ChinaNot yet recruiting
- Linfen Central HospitalLinfen, ChinaRecruiting
- Linfen People's HospitalLinfen, ChinaNot yet recruiting
- Beijing Tiantan Hospital , Capital Medical UniversityBeijing, ChinaNot yet recruiting
Related records
Drugs (2)
Lead sponsors (1)
Conditions (2)
- Ischemic stroke
- Transient ischemic attack Primary condition