A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Phase â…¢ Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset.
China1,112 participantsStarted 2026-01-19
Plain-language summary
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
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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);
✓. 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 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).
✕. 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;
What they're measuring
1
Proportion of subjects with mRS score 0-2 on day 90