Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction "CHARM"

Not yet recruiting

Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

1. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory
2. 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
3. Screening National Institutes of Health Stroke Scale (NIHSS) >=10
4. Study treatment infusion within 10 hours after time of symptom onset, if known, or the time last known normal
5. For participants who receive thrombectomy, inclusion into the study must be based on post-thrombectomy MRI-DWI

Exclusion Criteria

1. Participant is likely to have supportive care withdrawn on the first day
2. Commitment to decompressive craniectomy (DC) prior to enrollment
3. Evidence of concurrent infarction in the contralateral hemisphere sufficiently serious so as to affect functional outcome
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply