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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
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.
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.
Time frame: Day 90
Proportion of subjects with mRS score 0-1 on 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.
Time frame: Day 90
Day 90 mRS Displacement Analysis
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.
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Yuebei People's Hospital
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Nanyang, Henan, China
NOT_YET_RECRUITINGNanyang Second General Hospital
Nanyang, Henan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Nanyang Medicinal College
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NOT_YET_RECRUITINGMeiHekou Central Hospital
Meihekou, Jilin, China
NOT_YET_RECRUITINGBeipiao Central Hospital
Chaoyang, Liaoning, China
RECRUITING...and 14 more locations
Time frame: Day 90
Proportion of subjects with NIHSS scores ≤1 on day 10 (or at discharge)
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).
Time frame: Day 10
Proportion of subjects with a ≥4-point reduction in NIHSS score from baseline at day 10 (or at discharge)
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).
Time frame: D10
Proportion of subjects with ≥4 point increase in NIHSS score during hospitalisation
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).
Time frame: D1~ Day 10
Proportion of subjects with Barthel Index Scale (BI) scores ≥95 on 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.
Time frame: Day 90
Day 90 European Five Dimensional Health Scale (EQ-5D) Score
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) .
Time frame: Day 90
Mortality due to stroke within 90 days
Mortality due to stroke within 90 days
Time frame: Day 90
Change in infarct volume from baseline after 24 hours of dosing
Change in infarct volume from baseline after 24 hours of dosing
Time frame: 24 hours after treatment