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

January 18, 2024 updated by: Biogen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

535

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
      • New Lambton Heights, New South Wales, Australia, 2305
        • John Hunter Hospital
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • St Albans, Victoria, Australia, 3021
        • Sunshine Hospital
  • Belgium
      • Liege, Belgium, 4000
        • Clinique CHC MontLégia
    • East Flanders
      • Gent, East Flanders, Belgium, 9000
        • Universitair Ziekenhuis Gent
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • UZ Leuven
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • CHU UCL Namur
  • Brazil
    • Ceará
      • Fortaleza, Ceará, Brazil, 60155-290
        • HGF - Hospital Geral de Fortaleza
    • Paraná
      • Campo Largo, Paraná, Brazil, 83606-177
        • Hospital do Rocio
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89202-190
        • Clinica Neurologica e Neurocirurgica de Joinville
    • Sao Paulo
      • Ribeirao Preto, Sao Paulo, Brazil, 14048-900
        • Hospital Das Clínicas Fmrp-Usp
      • São Paulo, Sao Paulo, Brazil, 04037-002
        • Hospital Sao Paulo
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital
      • Beijing, Beijing, China, 100053
        • Xuanwu Hospital Capital Medical University
      • Beijing, Beijing, China, 100070
        • Beijing Tiantan Hospital, Capital Medical University
    • Bejing
      • Beijing, Bejing, China, 100070
        • Beijing Tiantan Hospital, Capital Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital of Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510260
        • the Second Affiliated Hospital of Guangzhou Medical University
    • Hainan
      • Haikou, Hainan, China, 570311
        • Hainan General Hospital
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital, Wuhan University
    • Jiangsu
      • Huai'an, Jiangsu, China, 223300
        • Huai'an First People's Hospital
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital Southeast University
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Nantong, Jiangsu, China, 226001
        • Affiliated Hospital of Nantong University
      • Xuzhou, Jiangsu, China, 221006
        • The Affiliated Hospital of Xuzhou Medical College
    • Jiangsushe
      • Suzhou, Jiangsushe, China, 215004
        • The Second Affiliated Hospital of Soochow University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The first affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial People's Hospital
      • Pingxiang, Jiangxi, China, 337055
        • Jiangxi Pingxiang People's Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital, Fudan University
    • Shanxi
      • Xi'an, Shanxi, China, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital）
    • Sichuan
      • Chongqing, Sichuan, China, 400042
        • Army Specialty Medical Center of The Chinese People's Liberation Army
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine
  • Croatia
    • Croatia Proper
      • Varazdin, Croatia Proper, Croatia, 42000
        • General Hospital Varazdin
      • Zagreb, Croatia Proper, Croatia, 10000
        • Clinical Hospital 'Sestre Milosrdnice'
      • Zagreb, Croatia Proper, Croatia, 10000
        • Clinical Hospital Centar Zagreb
  • Czechia
      • Hradec Kralove, Czechia, 50005
        • Fakultni nemocnice Hradec Kralove
    • Moravia
      • Brno, Moravia, Czechia, 625 00
        • Fakultní Nemocnice Brno
      • Brno, Moravia, Czechia, 656 91
        • Fakultni Nemocnice u sv. Anny v Brne
    • Moravian-Silesian
      • Ostrava, Moravian-Silesian, Czechia, 70852
        • Fakultni Nemocnice Ostrava
    • Prague
      • Praha 10, Prague, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Praha 5, Prague, Czechia, 150 06
        • Fakultni Nemocnice V Motole
  • Denmark
    • Copenhagen City
      • Copenhagen, Copenhagen City, Denmark, 2100
        • Copenhagen University Hospital and Glostrup Hospital
      • Copenhagen NV, Copenhagen City, Denmark, 2400
        • Bispebjerg og Frederiksberg Hospital
    • Østsjælland
      • Roskilde, Østsjælland, Denmark, 4000
        • Sjællands Universitetshospital
  • Finland
    • Southern
      • Helsinki, Southern, Finland, 00290 HUS
        • Helsinki University Hospital
    • Western
      • Turku, Western, Finland, 20521
        • Turun yliopistollinen keskussairaala
  • France
    • Calvados
      • Caen cedex 9, Calvados, France, 14033
        • CHU CAEN - Hôpital de la Côte de Nacre
    • Doubs
      • Besancon Cedex, Doubs, France, 25000
        • CHU Besançon - Hôpital Jean Minjoz
    • Finistere
      • Brest cedex 2, Finistere, France, 29609
        • CHU de Brest - Hôpital de la Cavale Blanche
    • Gironde
      • Bordeaux, Gironde, France, 33076
        • Groupe Hospitalier Pellegrin - Hôpital Pellegrin
    • Ille-et-Vilaine
      • Rennes cedex 09, Ille-et-Vilaine, France, 35033
        • CHU Rennes - Hôpital Pontchaillou
    • Loire Atlantique
      • Saint-Herblain, Loire Atlantique, France, 44800
        • CHU Nantes - Hopital Nord Laënnec
    • Meurthe Et Moselle
      • Nancy, Meurthe Et Moselle, France, 54035
        • CHU Nancy - Hôpital Central
    • Nord
      • Lille Cedex, Nord, France, 59037
        • Hopital Roger Salengro - CHU Lille
    • Val De Marne
      • Le Kremlin Bicêtre cedex, Val De Marne, France, 94275
        • Hôpital Bicêtre
  • Germany
      • Dresden, Germany, 1307
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
    • Baden Wuerttemberg
      • Freiburg, Baden Wuerttemberg, Germany, 79106
        • Universitaetsklinikum Freiburg
    • Bayern
      • Augsburg, Bayern, Germany, 86156
        • Klinikum Augsburg
      • Bad Neustadt Saale, Bayern, Germany, 97616
        • Rhon-Klnikum Campus Bad Neustadt
      • Erlangen, Bayern, Germany, 91054
        • Universitaetsklinikum Erlangen
    • Hessen
      • Frankfurt, Hessen, Germany, 60528
        • Klinikum der Johann Wolfgang Goethe-Universitaet
      • Frankfurt, Hessen, Germany, 65929
        • Klinikum Frankfurt Hoechst GmbH
      • Kassel, Hessen, Germany, 34125
        • Klinikum Kassel Gmbh
    • Nordrhein Westfalen
      • Essen, Nordrhein Westfalen, Germany, 45147
        • Universitaetsklinikum Essen
      • Muenster, Nordrhein Westfalen, Germany, 48149
        • Universitaetsklinikum Muenster
    • Thueringen
      • Altenburg, Thueringen, Germany, 04600
        • Klinikum Altenburger Land GmbH
      • Jena, Thueringen, Germany, 07749
        • Universitaetsklinikum Jena
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
    • Budapest
      • Kistarcsa, Budapest, Hungary, 2143
        • Pest Megyei Flor Ferenc Korhaz
    • Csongrád-Csanád
      • Szeged, Csongrád-Csanád, Hungary, 6725
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
    • Győr-Moson-Sopron
      • Gyor, Győr-Moson-Sopron, Hungary, 9023
        • Petz Aladar Egyetemi Oktato Korhaz
    • Somogy
      • Kaposvar, Somogy, Hungary, 7400
        • Somogy Megyei Kaposi Mór Oktató Kórház
    • Szabolcs-Szatmár-Bereg
      • Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Center
      • Jerusalem, Israel, 9112001
        • Hadassah University Hospital - Ein Kerem
      • Jerusalem, Israel, 9103102
        • Shaare Zedek
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
    • Central
      • Petah Tikva, Central, Israel, 49100
        • Rabin MC
    • Southern
      • Beer-Sheva, Southern, Israel, 84001
        • Soroka University Medical Center
  • Italy
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Firenze, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Genova, Italy, 16132
        • IRCCS Ospedale Policlinico San Martino
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Milano, Italy, 20122
        • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
      • Milano, Italy, 20162
        • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
      • Siena, Italy, 53100
        • A.O.U. Senese Policlinico Santa Maria alle Scotte
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas
    • Roma
      • Rome, Roma, Italy, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
      • Rome, Roma, Italy, 00161
        • Policlinico Umberto I
      • Rome, Roma, Italy, 00189
        • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
  • Japan
    • Aichi-Ken
      • Toyota-shi, Aichi-Ken, Japan, 471-8513
        • Toyota Memorial Hospital
    • Aomori-Ken
      • Hachinohe-shi, Aomori-Ken, Japan, 039-1104
        • Hachinohe Red Cross Hospital
    • Chiba-Ken
      • Kisarazu-shi, Chiba-Ken, Japan, 292-8535
        • Kimitsu Chuo Hospital
    • Fukuoka-Ken
      • Fukuoka-shi, Fukuoka-Ken, Japan, 810-8563
        • NHO Kyushu Medical Center
      • Fukuoka-shi, Fukuoka-Ken, Japan, 811-0213
        • Chiyukai Fukuoka Wajiro Hospital
      • Onga-gun, Fukuoka-Ken, Japan, 807-0051
        • Chiyukai Fukuoka Shinmizumaki Hospital
      • Yukuhashi-shi, Fukuoka-Ken, Japan, 824-0026
        • Chiyukai Shin Yukuhashi Hospital
    • Fukushima-Ken
      • Koriyama-shi, Fukushima-Ken, Japan, 963-8052
        • Southern Tohoku General Hospital
    • Gifu-Ken
      • Gifu-shi, Gifu-Ken, Japan, 500-8717
        • Gifu Prefectural General Medical Center
    • Hiroshima-Ken
      • Fukuyama-shi, Hiroshima-Ken, Japan, 720-0825
        • Showakai Brain Attack Center Ota Memorial Hospital
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 070 8530
        • Asahikawa Red Cross Hospital
    • Hyogo-Ken
      • Akashi-shi, Hyogo-Ken, Japan, 674-0064
        • Ohnishi Neurological Center
      • Kobe-shi, Hyogo-Ken, Japan, 650-0047
        • Kobe City Hospital Organization Kobe City Medical Center General Hospital
    • Ibaraki-Ken
      • Tsuchiura-shi, Ibaraki-Ken, Japan, 300-0028
        • Tsuchiura Kyodo General Hospital
    • Iwate-Ken
      • Morioka-shi, Iwate-Ken, Japan, 020-0066
        • Iwate Prefectural Central Hospital
    • Kanagawa-Ken
      • Kawasaki-shi, Kanagawa-Ken, Japan, 216-8511
        • St. Marianna University Hospital
    • Miyagi-Ken
      • Sendai-shi, Miyagi-Ken, Japan, 983-8520
        • NHO Sendai Medical Center
    • Okayama-Ken
      • Kurashiki-shi, Okayama-Ken, Japan, 710-8602
        • Kurashiki Central Hospital
      • Okayama-shi, Okayama-Ken, Japan, 700-8557
        • Okayama City General Medical Center Okayama City Hospital
    • Osaka Prefecture
      • Suita, Osaka Prefecture, Japan, 564-8565
        • National Cerebral and Cardiovascular Center
    • Osaka-Fu
      • Izumisano-shi, Osaka-Fu, Japan, 598-8577
        • Rinku General Medical Center
    • Saitama-Ken
      • Hidaka-shi, Saitama-Ken, Japan, 350 1298
        • Saitama Medical University International Medical Center
    • Tokyo-To
      • Bunkyo-ku, Tokyo-To, Japan, 113-8603
        • Nippon Medical School Hospital
      • Fuchu-shi, Tokyo-To, Japan, 183-8524
        • Tokyo Metropolitan Tama Medical Center
      • Mitaka-shi, Tokyo-To, Japan, 181-8611
        • Kyorin University Hospital
    • Wakayama-Ken
      • Tanabe-shi, Wakayama-Ken, Japan, 646 8558
        • NHO Minami Wakayama Medical Center
    • Yamaguchi-Ken
      • Ube-shi, Yamaguchi-Ken, Japan, 755-8505
        • Yamaguchi University Hospital
    • Yamanashi-Ken
      • Kofu-shi, Yamanashi-Ken, Japan, 400-8506
        • Yamanashi Prefectural Central Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Seoul, Korea, Republic of, 5505
        • Asan Medical Center
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Gyeongsangnam-do
      • Daegu, Gyeongsangnam-do, Korea, Republic of, 41944
        • Kyungpook National University Hospital
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santariskiu Clinic, Public Institution
      • Vilnius, Lithuania, 04130
        • Republican Vilnius University Hospital, Public Institution
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospitais da Universidade de Coimbra
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
      • Lisboa, Portugal, 1349-019
        • Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz
      • Porto, Portugal, 4200-319
        • Centro Hospitalar de São João, E.P.E
    • Aveiro
      • Santa Maria da Feira, Aveiro, Portugal, 4520-211
        • Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
    • Porto
      • Matosinhos, Porto, Portugal, 4454-509
        • Unidade Local de Saúde de Matosinhos, E.P.E. - Hospital Pedro Hispano
    • Setubal
      • Almada, Setubal, Portugal, 2801-915
        • Hospital Garcia de Orta, EPE
  • Russian Federation
      • Krasnodar, Russian Federation, 350086
        • SHI "Territorial Clinical Hospital #1 n.a. S.V. Ochapovsky"
      • Moscow, Russian Federation, 119049
        • SBIH of Moscow 'City Clinical Hospital # 1 n. a. N. I. Pirogov'
    • Leningrad
      • Saint Petersburg, Leningrad, Russian Federation, 196247
        • SPb SBIH 'City Hospital # 26'
      • St. Petersburg, Leningrad, Russian Federation, 192242
        • Saint-Petersburg Scientific-Research Institute of Emergency Care
    • Respublka Tatarstan
      • Kazan, Respublka Tatarstan, Russian Federation, 420061
        • SBEI HPE 'Kazan State Medical University' of the MoH of the RF
  • Spain
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Girona, Spain, 17007
        • Hospital Universitari de Girona Dr Josep Trueta
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen Del Rocio
      • Sevilla, Spain, 41071
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valladolid, Spain, 47005
        • Hospital Clínico Universitario de Valladolid
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
    • Córdoba
      • Cordoba, Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago
    • Málaga
      • Malaga, Málaga, Spain, 29010
        • Hospital Regional Universitario de Malaga
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital - Universitaetsspital Bern
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
        • Ospedale Regionale di Lugano
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital,Linkou
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
    • Greater London
      • London, Greater London, United Kingdom, WC1N 3BG
        • The National Hospital for Neurology & Neurosurgery
      • London, Greater London, United Kingdom, SE5 8EF
        • King's College Hospital
      • London, Greater London, United Kingdom, W6 8RF
        • Imp Coll Health Nhst 1
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham University Hospitals City Campus
    • Strathclyde
      • Glasgow, Strathclyde, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital Campus
    • Tyne & Wear
      • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE4 5PL
        • Newcastle University- Clinical Ageing Research Unit
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
      • Tucson, Arizona, United States, 85724
        • Arizona Board of Regents, University of Arizona
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Stroke Center
      • Sacramento, California, United States, 95817
        • University of California Davis Health System
      • San Diego, California, United States, 92121
        • UCSD Health-La Jolla
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale New Haven Hospital
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida-Gainsville
      • Jacksonville, Florida, United States, 32209
        • University of Florida, Jacksonville
      • Jacksonville, Florida, United States, 32207
        • Lyerly Neurosurgery Baptist Health
      • Tampa, Florida, United States, 33612
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital
      • Augusta, Georgia, United States, 30912
        • Augusta University
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queens Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center Research Institute, Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Brigham and Woman's Hospital
      • Jamaica Plain, Massachusetts, United States, 02130-2075
        • Beth Israel Deaconess Medical Center, Inc.
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48236
        • St. John's Hospital
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke'S Hospital of Kansas City
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University
      • Saint Louis, Missouri, United States, 63110
        • Washington University Physicians
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • JFK Medical Center
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers - Robert Wood Johnson Medical School
      • Ridgewood, New Jersey, United States, 07450
        • Valley Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico
    • New York
      • Buffalo, New York, United States, 14215
        • University of Buffalo
      • Manhasset, New York, United States, 11030
        • Northwell Health
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • New York, New York, United States, 10032
        • Columbia University Hervert Irving Comprehensive Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Hospitals
      • Charlotte, North Carolina, United States, 28204
        • Atrium Health Carolinas Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greensboro, North Carolina, United States, 27405
        • Guilford Neurologic Research, PA
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Forsyth Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health Sciences
    • Ohio
      • Akron, Ohio, United States, 44304
        • SUMMA Health System
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State Univ College Of Medicine
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital South
      • Toledo, Ohio, United States, 43606
        • ProMedica Toledo Hospital
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Ascension St. John
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
      • Portland, Oregon, United States, 97225
        • Providence Brain and Spine Institute
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital - Cedar Crest
      • Hershey, Pennsylvania, United States, 17033
        • Penn State University Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh School of Medicine
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Rhode Island Hospital Warren Alpert Medical School Brown University
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Health System
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Sciences Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Medical Center
      • Nashville, Tennessee, United States, 37207
        • TriStar Skyline Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • St.David's HealthCare Office of Research
      • Harlingen, Texas, United States, 78550
        • Valley Baptist Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Neurology
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington School of Medicine
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University Hospital and UW Health Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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. 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 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.
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIIB093
BIIB093 administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
Drug: BIIB093
Administered as specified in the treatment arm.
Other Names:
  • glibenclamide
  • glibenclamide intravenous (IV)
  • glyburide
  • CIRARA
Placebo Comparator: Placebo
Placebo administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
Drug: Placebo
Administered as specified in the treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS)
Time Frame: Day 90
The mRS measures the degree of functional independence following stroke. In this study, 7-category ordinal mRS scale was condensed to the following 5-categories: 0/1, 2, 3, 4, 5/6 where 0 and 1 reflect no disability and near-normal functioning while 5 and 6 represent severe disability and death, respectively.
Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Time to All-Cause Death Through Day 90
Time Frame: Randomization up to Day 90
Time to all-cause death is defined as the time from randomization to the time of death.
Randomization up to Day 90
Part 1: Percentage of Participants Who Achieved mRS 0-4 at Day 90
Time Frame: Day 90
The mRS measures the degree of functional independence following stroke. In this study, the 7-category ordinal mRS scale was condensed to the following 5-categories: 0/1, 2, 3, 4, 5/6 where 0 and 1 reflect no disability and near-normal functioning while 5 and 6 represent severe disability and death, respectively.
Day 90
Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From the signing of informed consent up to the last follow-up visit (up to 4 years 11 months)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly.
From the signing of informed consent up to the last follow-up visit (up to 4 years 11 months)
Part 1: Midline Shift at 72 Hours as Assessed by Non-contrast Computed Tomography (NCCT) or Magnetic Resonance Imaging (MRI)
Time Frame: At 72 hours
Midline shift is the perpendicular distance between the septum pellucidum and the line drawn between the anterior and posterior attachments of the falx to the inner table of the skull.
At 72 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 2: mRS Score
Time Frame: Month 6 and 12
mRS is a standardized interview that measures the degree of disability or dependence in the daily activities of participants who have suffered causes of neurological disability. The score will be calculated as a 5-category ordinal scale. The 5-category mRS combines mRS categories 0 and 1 and mRS categories 5 and 6 (0/1, 2, 3, 4, 5/6). The mRS ranges from 0 to 6, with higher scores indicating worse outcome.
Month 6 and 12
Part 2: EuroQol 5-Level Assessment of Health Outcomes (EQ-5D-5L) Score
Time Frame: Month 6 and 12
The questionnaire of EQ-5D-5L contains 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and uses a 5-point Likert scale scored from 1 (no problem) to 5 (unable to/extreme problems). The numerical description of 5 dimensions represents the health state and is defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).
Month 6 and 12
Part 2: Barthel Index (BI) Score
Time Frame: Month 6 and 12
BI measures the extent to which somebody can function independently and has mobility in their activities of daily living. It is a 10-item ordinal scale that cover mobility and self-care domains (feeding [0-10], bathing [0-5], grooming [0-5], dressing [0-10], bowel control [0-10], bladder control [0-10], toileting [0-10], chair transfer [0-15], ambulation [0-15], and stair climbing [0-10]). Total score is the sum of individual scores of each item, ranging from 0 (total dependence) to 100 (complete independence).
Month 6 and 12
Part 2: Stroke Impact Scale 16 Questions (SIS-16) Score
Time Frame: Month 6 and 12
The SIS-16 is developed to assess physical function in participants with stroke at approximately 1 to 3 months poststroke. It is a subjective questionnaire asked to the participant pertaining of 16 questions. Each question is rated 1-5 and then the scores are totalled. Total scores can range from 16-80 (16 means that none of the functional tasks asked can be performed, a score of 80 means the participant has no issues at all performing any of the tasks asked).
Month 6 and 12
Part 2: Zarit Burden Interview Score
Time Frame: Month 12
The interview is developed to measure subjective burden among caregivers of adults with dementia. The 22-item self-report inventory examines burden associated with functional/behavioral impairments and the home care situation. The items are worded subjectively, focusing on the affective response of the caregiver. Scores range from 0 to 88 where lower scores indicate little to no burden. Higher scores indicate greater burden.
Month 12
Part 2: HealthCare Resource Utilization (HCRU) Questionnaire: Number of Participants With Visits to Healthcare Professionals for Treatment
Time Frame: Month 12
HCRU questionnaire will collect data on the healthcare resources used over the course of the study. They are developed to address the need for valid costing estimates of a particular disease state. They are developed to capture the quantity of resources used to extrapolate the overall cost of a disease or impact of an intervention.
Month 12
Part 2: Number of Participants With SAEs
Time Frame: Up to Month 12
A SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly.
Up to Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2018

Primary Completion (Actual)

August 18, 2023

Study Completion (Actual)

August 18, 2023

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimated)

August 12, 2016

Study Record Updates

Last Update Posted (Actual)

February 13, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 252LH301
  • RPI 301 (Other Identifier: Remedy Pharmaceuticals)
  • 2017-004854-41 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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