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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Brain Edema, Stroke, Acute

In brief

The primary objective of Part 1 of the study 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). The secondary objectives of Part 1 of the study are to determine if BIIB093 improves overall survival at Day 90 when compared with placebo, if BIIB093 improves functional outcome at Day 90 on the mRS dichotomized 0-4 vs. 5-6 when compared with placebo, if BIIB093 reduces midline shift at 72 hours (or at time of decompressive craniectomy \[DC\] or comfort measures only \[CMO\], if earlier) when compared with placebo, and to evaluate the safety and tolerability of BIIB093 in participants with LHI. The objectives of Part 2 of the study are to evaluate long-term disability following LHI, to evaluate long-term outcome measures of clinical function, quality of life, and healthcare utilization, and to assess the safety of BIIB093 in subjects with LHI during the follow-up period.

Key facts

Study ID

NCT02864953

Run by

Remedy Pharmaceuticals, Inc.

People needed

535

Starts

2018-08-29

Expected to finish

2023-08-18

Last updated by the study team

2024-11-25

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• At the time of randomization, and in the Investigator's judgement, it must be feasible for study drug treatment infusion to be initiated no later than 10 hours after time of symptom onset, if known, or the time last known normal.
• Participants who wake with stroke may be included if neurological and other exclusion criteria are satisfied. The time of stroke onset is to be taken as the midpoint between sleep onset (or last known to be normal) and time of waking.
• For participants who receive thrombectomy, inclusion into the study must be based on post-thrombectomy MRI-DWI.

You may not qualify if…

• Participant is likely to have supportive care withdrawn on the first day.
• Commitment to decompressive craniectomy (DC) prior to enrollment.
• 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

Where it is running

• Arizona Board of Regents, University of Arizona — Tucson, Arizona, United States
• Stanford Stroke Center — Palo Alto, California, United States
• University of California Davis Health System — Sacramento, California, United States
• UCSD Health-La Jolla — San Diego, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• University of Florida-Gainsville — Gainesville, Florida, United States
• Lyerly Neurosurgery Baptist Health — Jacksonville, Florida, United States
• University of Florida, Jacksonville — Jacksonville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• The Queens Medical Center — Honolulu, Hawaii, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• University of Maryland — Baltimore, Maryland, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Woman's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center, Inc. — Jamaica Plain, Massachusetts, United States
• UMASS Memorial Medical Center — Worcester, Massachusetts, United States
• Barrow Neurological Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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