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Phase III

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

  • Study HIC#:2000023235
  • Last Updated:07/15/2021

Brief Summary:

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). The secondary objectives 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.

  • Age18 years - 85 years
  • GenderBoth
  • Start Date11/28/2018
  • End Date02/28/2022

Trial Purpose and Description

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction (CHARM Study: Glibenclamide for large hemispheric infarction analyzing mRS and mortality)

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 Participant is likely to have supportive care withdrawn on the first day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