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
    Nov 30, 2022
  • participants needed
    768
  • sponsor
    Biogen
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Updated on 17 January 2021
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Investigator
Biogen
Primary Contact
Research Site (7.7 mi away) Contact
+210 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
Treatment Placebo, BIIB093
Clinical Study IdentifierNCT02864953
SponsorBiogen
Last Modified on17 January 2021

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 85 yrs?
Gender: Male or Female
Do you have any of these conditions: Cerebrovascular accident or Stroke or Cerebral Edema?
Do you have any of these conditions: brain swelling or brain edema or Cerebrovascular accident or acute stroke or Stroke or Cerebral Edema?
Do you have any of these conditions: brain swelling or acute stroke or brain edema or Cerebral Edema or Stroke or Cerebrovascular accident?
Do you have any of these conditions: Cerebrovascular accident or Stroke or Cerebral Edema or brain swelling or acute stroke or brain edema?
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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