A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset.

ConditionAIS
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBiocells (Beijing) Biotech Co.,Ltd

About this trial

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

Eligibility criteria

Qualifiers

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);

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • BXOS110
  • placebo

Treatment groups

1,112 Participants
are divided into 2 treatment groups