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

  • STATUS
    Recruiting
  • End date
    Sep 29, 2024
  • participants needed
    768
  • sponsor
    Biogen
Updated on 31 July 2021
Investigator
Biogen
Primary Contact
Research Site (9.4 mi away) Contact
+221 other location
stroke
infarct
MRI
ischemic stroke
thrombectomy
glibenclamide
glyburide

Summary

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.

Description

This study, previously posted by Remedy Pharmaceuticals, Inc., has transitioned to Biogen.

Details
Condition Cerebrovascular accident, Cerebral Edema, Stroke, acute stroke, brain edema, brain swelling
Treatment Placebo, BIIB093
Clinical Study IdentifierNCT02864953
SponsorBiogen
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
For participants who receive thrombectomy, inclusion into the study must be based on post-thrombectomy MRI-DWI
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

Exclusion Criteria

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
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