Last updated on March 2019

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


Brief description of study

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.

Detailed Study Description

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

Clinical Study Identifier: NCT02864953

Find a site near you

Start Over

Research Site

Phoenix, AZ United States
  Connect »

Research Site

Palo Alto, CA United States
  Connect »

Research Site

New Haven, CT United States
  Connect »

Research Site

Atlantis, FL United States
  Connect »

Research Site

Gainesville, FL United States
  Connect »

Research Site

Jacksonville, FL United States
  Connect »

Research Site

Tampa, FL United States
  Connect »

Research Site

Atlanta, GA United States
  Connect »

Research Site

Augusta, GA United States
  Connect »

Research Site

Honolulu, HI United States
  Connect »

Research Site

Chicago, IL United States
  Connect »

Research Site

Kansas City, KS United States
  Connect »

Research Site

Louisville, KY United States
  Connect »

Research Site

New Orleans, LA United States
  Connect »

Research Site

Scarborough, ME United States
  Connect »

Research Site

College Park, MD United States
  Connect »

Research Site

Boston, MA United States
  Connect »

Research Site 1

Boston, MA United States
  Connect »

Research Site 2

Boston, MA United States
  Connect »

Research Site

Worcester, MA United States
  Connect »

Research Site

Detroit, MI United States
  Connect »

Research Site

Minneapolis, MN United States
  Connect »

Research Site

Brick, NJ United States
  Connect »

Research Site

Ridgewood, NJ United States
  Connect »

Research Site

New York, NY United States
  Connect »

Research Site 1

New York, NY United States
  Connect »

Research Site 2

New York, NY United States
  Connect »

Research Site

Rochester, NY United States
  Connect »

Research Site

Syracuse, NY United States
  Connect »

Research Site

Chapel Hill, NC United States
  Connect »

Research Site

Durham, NC United States
  Connect »

Research Site

Cincinnati, OH United States
  Connect »

Research Site

Cleveland, OH United States
  Connect »

Research Site

Columbus, OH United States
  Connect »

Research Site

Toledo, OH United States
  Connect »

Research Site

Portland, OR United States
  Connect »

Research Site

Allentown, PA United States
  Connect »

Research Site

Hershey, PA United States
  Connect »

Research Site

Philadelphia, PA United States
  Connect »

Research Site

Pittsburgh, PA United States
  Connect »

Research Site

Providence, RI United States
  Connect »

Research Site

Columbia, SC United States
  Connect »

Research Site

Chattanooga, TN United States
  Connect »

Research Site

Nashville, TN United States
  Connect »

Research Site

Harlingen, TX United States
  Connect »

Research Site

Salt Lake City, UT United States
  Connect »

Research Site

North Melbourne, Australia
  Connect »

Research Site

Porto Alegre, Brazil
  Connect »

Research Site

Ribeirao Preto, Brazil
  Connect »

Research Site

Sao Paulo, Brazil
  Connect »

Research Site

Hradec Kralove, Czechia
  Connect »

Research Site

Ostrava-Poruba, Czechia
  Connect »

Research Site

Copenhagen, Denmark
  Connect »

Research Site

Helsinki, Finland
  Connect »

Research Site

Besancon, France
  Connect »

Research Site

Lille Cedex, France
  Connect »

Research Site

Maumusson, France
  Connect »

Research Site

Altenburg, Germany
  Connect »

Research Site

Augsburg, Germany
  Connect »

Research Site

Darmstadt, Germany
  Connect »

Research Site

Dresden, Germany
  Connect »

Research Site

Frankfurt, Germany
  Connect »

Research Site

Freiburg, Germany
  Connect »

Research Site

Muenster, Germany
  Connect »

Research Site

Budapest, Hungary
  Connect »

Research Site

Kistarcsa, Hungary
  Connect »

Research Site

Nyiregyhaza, Hungary
  Connect »

Research Site

Be'er Sheva, Israel
  Connect »

Research Site

Jerusalem, Israel
  Connect »

Research Site

Tel Aviv, Israel
  Connect »

Research Site

Busan, Korea, Republic of
  Connect »

Research Site

Seoul, Korea, Republic of
  Connect »

Research Site

Coimbra, Portugal
  Connect »

Research Site

Barcelona, Spain
  Connect »

Research Site

Santiago de Compostela, Spain
  Connect »

Research Site

Aarau, Switzerland
  Connect »

Research Site

Lugano, Switzerland
  Connect »

Research Site

Bern, Switzerland
  Connect »

Research Site

Kaohsiung, Taiwan
  Connect »

Research Site

Cambridge, United Kingdom
  Connect »

Research Site

London, United Kingdom
  Connect »

Research Site

Glasgow, United Kingdom
  Connect »

Research Site

Nottingham, United Kingdom
  Connect »

Research Site

Newcastle upon Tyne, United Kingdom
  Connect »

Research Site

Matsumoto, Japan
  Connect »

Research Site

Kurashiki, Japan
  Connect »

Research Site

Kazan, Russian Federation
  Connect »