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Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction
The primary objective is to determine if BIIB093 improves functional outcome at Day 90 as measured by the modified Rankin Scale (mRS) when compared with placebo in participants with Large Hemispheric Infarction (LHI).
- A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory
- A large hemispheric infarction defined as; lesion volume of 80 to 300 centimeters cubed (cm^3) on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP), or an Alberta Stroke Program Early CT Score (ASPECTS) of 1 to 5 with involvement of at least 2 defined cortical regions
- Screening National Institutes of Health Stroke Scale (NIHSS) >=10
- Study treatment infusion within 10 hours after time of symptom onset, if known, or the time last known normal
- For participants who receive thrombectomy, inclusion into the study must be based on post-thrombectomy MRI-DWI