Effectiveness and Safety of Experimental BIIB093 (Glibenclamide) for Severe Cerebral Edema (fluid around brain) After Stroke

a study on Brain Edema Stroke

Summary

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

Description

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.

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

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. 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

You CAN'T join if...

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.

  1. 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

Locations

  • University of California Davis Health System
    Sacramento California 95817 United States
  • Stanford Stroke Center
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
Remedy Pharmaceuticals, Inc.
ID
NCT02864953
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 535 people participating
Last Updated
Contact us about this trial