Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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

Keywords

Brain Edema Stroke, Acute Infarction Cerebrovascular Disorders Brain Diseases Pathological Processes Necrosis Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases Glyburide Hypoglycemic Agents Physiological Effects of Drugs Stroke Edema BIIB093

Eligibility

You can join if…

Open to people ages 18-85

  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 (cm3) 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

You CAN'T join if...

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 Participant is likely to have supportive care withdrawn on the first day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

Locations

  • Research Site not yet accepting patients
    Sacramento California 95817 United States
  • Research Site accepting new patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Biogen
Links
Sign up for this study
ID
NCT02864953
Phase
Phase 3
Study Type
Interventional
Last Updated