Protocol Summary

Protocol No.: OCR20240

Sponsor Protocol No.: 252LH301

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

Principal Investigator: Yuzefovich Khanna, Anna

Objective: 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.

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

Phase: Phase III

Age Group: Adult

Age: 18 Years - 85 Years

Gender: All

Scope: National

Treatment:

Experimental: BIIB093
BIIB093 administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.

Placebo Comparator: Placebo
Placebo administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.

Detailed Eligibility:

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 Participant is likely to have supportive care withdrawn on the first day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

Applicable Conditions:

  • Supratentorial Intracerebral Hemorrhage
  • Participation Institution:

  • No UF Health MRN : Teresa Lyles
  • UF Gainesville : Teresa Lyles
  • UF Jacksonville : Teresa Lyles
  • Contact:
    Teresa Lyles
    Email: talyles@ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02864953