AzTrials
AzTrials

Brain EdemaPhase 3CHARMNCT02864953

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

A Phase 3 study testing BIIB093 in people with Brain Edema and Stroke, Acute, run by Remedy Pharmaceuticals, Inc. at 250 sites in 24 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Brain Edema, Stroke, Acute
What is being tested?
BIIB093
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
535 participants
Where
250 sitesin 24 countries
Study dates
29 Aug 2018to 18 Aug 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • For participants who receive thrombectomy, inclusion into the study must be based on post-thrombectomy MRI-DWI.

Who cannot join

  • 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

Trial locations and contacts

250 sites in 24 countries.

250 sites in 24 countries

United States74 sites

  • Summa Health System

    Akron, Ohio, 44304

  • University of New Mexico

    Albuquerque, New Mexico, 87106

  • Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18103

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Augusta University

    Augusta, Georgia, 30912

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • St.David's HealthCare Office of Research

    Austin, Texas, 78705

  • University of Maryland

    Baltimore, Maryland, 21201

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Woman's Hospital

    Boston, Massachusetts, 02115

  • University of Buffalo

    Buffalo, New York, 14215

  • UNC Hospitals

    Chapel Hill, North Carolina, 27514

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina, 28204

  • Erlanger Health System

    Chattanooga, Tennessee, 37403

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State Univ College Of Medicine

    Columbus, Ohio, 43210

  • Miami Valley Hospital South

    Dayton, Ohio, 45409

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • St. John's Hospital

    Detroit, Michigan, 48236

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • JFK Medical Center

    Edison, New Jersey, 08820

  • University of Florida-Gainsville

    Gainesville, Florida, 32610

  • Guilford Neurologic Research, PA

    Greensboro, North Carolina, 27405

  • Valley Baptist Medical Center

    Harlingen, Texas, 78550

  • Penn State University Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • The Queens Medical Center

    Honolulu, Hawaii, 96813

  • Lyerly Neurosurgery Baptist Health

    Jacksonville, Florida, 32207

  • University of Florida, Jacksonville

    Jacksonville, Florida, 32209

  • Beth Israel Deaconess Medical Center, Inc.

    Jamaica Plain, Massachusetts, 02130-2075

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • University of Louisville

    Louisville, Kentucky, 40202

  • University Hospital and UW Health Clinics

    Madison, Wisconsin, 53705

  • Northwell Health

    Manhasset, New York, 11030

  • University of Tennessee Health Sciences Center

    Memphis, Tennessee, 38163

  • TriStar Skyline Medical Center

    Nashville, Tennessee, 37207

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Rutgers - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Yale New Haven Hospital

    New Haven, Connecticut, 06519

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • NYU Langone Medical Center

    New York, New York, 10016

  • Mount Sinai Hospital

    New York, New York, 10029

  • Columbia University Hervert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Stanford Stroke Center

    Palo Alto, California, 94304

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania, 15261

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence Brain and Spine Institute

    Portland, Oregon, 97225

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital Warren Alpert Medical School Brown University

    Providence, Rhode Island, 02905

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California Davis Health System

    Sacramento, California, 95817

  • University of Utah Neurology

    Salt Lake City, Utah, 84108

  • UCSD Health-La Jolla

    San Diego, California, 92121

  • University of Washington School of Medicine

    Seattle, Washington, 98195

  • Saint Louis University

    St Louis, Missouri, 63110

  • Washington University Physicians

    St Louis, Missouri, 63110

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210

  • University of South Florida

    Tampa, Florida, 33612

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606

  • Arizona Board of Regents, University of Arizona

    Tucson, Arizona, 85724

  • Ascension St. John

    Tulsa, Oklahoma, 74104

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest Baptist Health Sciences

    Winston-Salem, North Carolina, 27157

  • UMASS Memorial Medical Center

    Worcester, Massachusetts, 01605

Other trials in United States

Japan28 sites

  • Ohnishi Neurological Center

    Akashi-shi, Hyōgo, 674-0064

  • Asahikawa Red Cross Hospital

    Asahikawa-shi, Hokkaido, 070 8530

  • Nippon Medical School Hospital

    Bunkyō City, Tokyo-To, 113-8603

  • Tokyo Metropolitan Tama Medical Center

    Fuchu-shi, Tokyo-To, 183-8524

  • NHO Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563

  • Chiyukai Fukuoka Wajiro Hospital

    Fukuoka, Fukuoka, 811-0213

  • Showakai Brain Attack Center Ota Memorial Hospital

    Fukuyama-shi, Hiroshima, 720-0825

  • Gifu Prefectural General Medical Center

    Gifu, Gifu, 500-8717

  • Hachinohe Red Cross Hospital

    Hachinohe-shi, Aomori, 039-1104

  • Saitama Medical University International Medical Center

    Hidaka-shi, Saitama, 350 1298

  • Rinku General Medical Center

    Izumisano, Osaka, 598-8577

  • St. Marianna University Hospital

    Kawasaki-shi, Kanagawa, 216-8511

  • Kimitsu Chuo Hospital

    Kisarazu-shi, Chiba, 292-8535

  • Kobe City Hospital Organization Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi, 400-8506

  • Southern Tohoku General Hospital

    Koriyama-shi, Fukushima, 963-8052

  • Kurashiki Central Hospital

    Kurashiki-shi, Okayama-ken, 710-8602

  • Kyorin University Hospital

    Mitaka-shi, Tokyo-To, 181-8611

  • Iwate Prefectural Central Hospital

    Morioka, Iwate, 020-0066

  • Okayama City General Medical Center Okayama City Hospital

    Okayama, Okayama-ken, 700-8557

  • Chiyukai Fukuoka Shinmizumaki Hospital

    Onga-gun, Fukuoka, 807-0051

  • NHO Sendai Medical Center

    Sendai, Miyagi, 983-8520

  • National Cerebral and Cardiovascular Center

    Suita, Osaka, 564-8565

  • NHO Minami Wakayama Medical Center

    Tanabe-shi, Wakayama, 646 8558

  • Toyota Memorial Hospital

    Toyota-shi, Aichi-ken, 471-8513

  • Tsuchiura Kyodo General Hospital

    Tsuchiura-shi, Ibaraki, 300-0028

  • Yamaguchi University Hospital

    Ube-shi, Yamaguchi, 755-8505

  • Chiyukai Shin Yukuhashi Hospital

    Yukuhashi-shi, Fukuoka, 824-0026

Other trials in Japan

China25 sites

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Bejing, 100070

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Army Specialty Medical Center of The Chinese People's Liberation Army

    Chongqing, Sichuan, 400042

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • Huai'an First People's Hospital

    Huai'an, Jiangsu, 223300

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337055

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsushe, 215004

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

  • Renmin Hospital, Wuhan University

    Wuhan, Hubei, 430060

  • The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)

    Xi’an, Shanxi, 710004

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu, 221006

Other trials in China

Germany12 sites

  • Klinikum Altenburger Land GmbH

    Altenburg, Thuringia, 04600

  • Klinikum Augsburg

    Augsburg, Bavaria, 86156

  • Rhon-Klnikum Campus Bad Neustadt

    Bad Neustadt Saale, Bavaria, 97616

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 1307

  • Universitaetsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt am Main, Hesse, 60528

  • Klinikum Frankfurt Hoechst GmbH

    Frankfurt am Main, Hesse, 65929

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitaetsklinikum Jena

    Jena, Thuringia, 07749

  • Klinikum Kassel GmbH

    Kassel, Hesse, 34125

  • Universitaetsklinikum Muenster

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Spain12 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Reina Sofia

    Córdoba, Córdoba, 14004

  • Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Regional Universitario de Malaga

    Málaga, Málaga, 29010

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, La Coruña, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Virgen Macarena

    Seville, 41071

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47005

Other trials in Spain

Italy11 sites

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia, 25123

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

    Milan, 20162

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome, Roma, 00133

  • Policlinico Umberto I

    Rome, Roma, 00161

  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

    Rome, Roma, 00189

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    Siena, 53100

Other trials in Italy

Australia9 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

France9 sites

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, Doubs, 25000

  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin

    Bordeaux, Gironde, 33076

  • CHU de Brest - Hôpital de la Cavale Blanche

    Brest, Finistere, 29609

  • CHU CAEN - Hôpital de la Côte de Nacre

    Caen, Calvados, 14033

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, Val De Marne, 94275

  • Hopital Roger Salengro - CHU Lille

    Lille, Nord, 59037

  • CHU Nancy - Hôpital Central

    Nancy, Meurthe Et Moselle, 54035

  • CHU Rennes - Hopital Pontchaillou

    Rennes, Ille-et-Vilaine, 35033

  • CHU Nantes - Hopital Nord Laënnec

    Saint-Herblain, Loire Atlantique, 44800

Other trials in France

Portugal7 sites

  • Hospital Garcia de Orta, EPE

    Almada, Setúbal District, 2801-915

  • Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospitais da Universidade de Coimbra

    Coimbra, 3000-075

  • Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz

    Lisbon, 1349-019

  • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

    Lisbon, 1649-035

  • Unidade Local de Saúde de Matosinhos, E.P.E. - Hospital Pedro Hispano

    Matosinhos Municipality, Porto District, 4454-509

  • Centro Hospitalar de São João, E.P.E

    Porto, 4200-319

  • Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião

    Santa Maria da Feira, Aveiro District, 4520-211

Other trials in Portugal

United Kingdom7 sites

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

  • Queen Elizabeth University Hospital Campus

    Glasgow, Strathclyde, G51 4TF

  • King's College Hospital

    London, Greater London, SE5 8EF

  • Imp Coll Health Nhst 1

    London, Greater London, W6 8RF

  • The National Hospital for Neurology & Neurosurgery

    London, Greater London, WC1N 3BG

  • Newcastle University- Clinical Ageing Research Unit

    Newcastle upon Tyne, Tyne & Wear, NE4 5PL

  • Nottingham University Hospitals City Campus

    Nottingham, Nottinghamshire, NG5 1PB

Other trials in United Kingdom

Brazil6 sites

  • Hospital do Rocio

    Campo Largo, Paraná, 83606-177

  • HGF - Hospital Geral de Fortaleza

    Fortaleza, Ceará, 60155-290

  • Clinica Neurológica e Neurocirúrgica de Joinville

    Joinville, Santa Catarina, 89202-190

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clínicas FMRP-USP

    Ribeirão Preto, São Paulo, 14048-900

  • Hospital Sao Paulo

    São Paulo, São Paulo, 04037-002

Other trials in Brazil

Czechia6 sites

  • Fakultni nemocnice Brno

    Brno, Moravia, 625 00

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, Moravia, 656 91

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50005

  • Fakultni nemocnice Ostrava

    Ostrava, Moravian-Silesian, 70852

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Prague, 100 34

  • Fakultni nemocnice v Motole

    Prague, Prague, 150 06

Other trials in Czechia

Hungary6 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Petz Aladar Egyetemi Oktato Korhaz

    Győr, Győr-Moson-Sopron, 9023

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvár, Somogy County, 7400

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, Budapest, 2143

  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, Csongrád-Csanád, 6725

Other trials in Hungary

Israel6 sites

  • Soroka University Medical Center

    Beersheba, Southern District, 84001

  • Rambam Health Care Center

    Haifa, 3109601

  • Shaare Zedek

    Jerusalem, 9103102

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

  • Rabin MC

    Petah Tikva, Central District, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Russia5 sites

  • SBEI HPE 'Kazan State Medical University' of the MoH of the RF

    Kazan', Respublka Tatarstan, 420061

  • SHI "Territorial Clinical Hospital #1 n.a. S.V. Ochapovsky"

    Krasnodar, 350086

  • SBIH of Moscow 'City Clinical Hospital # 1 n. a. N. I. Pirogov'

    Moscow, 119049

  • Saint-Petersburg Scientific-Research Institute of Emergency Care

    Saint Petersburg, Sankt-Peterburg, 192242

  • SPb SBIH 'City Hospital # 26'

    Saint Petersburg, Sankt-Peterburg, 196247

Other trials in Russia

Belgium4 sites

  • Universitair Ziekenhuis Gent

    Ghent, East Flanders, 9000

  • UZ Leuven

    Leuven, Flemish Brabant, 3000

  • Clinique CHC MontLégia

    Liège, 4000

  • CHU UCL Namur

    Yvoir, Namur, 5530

Other trials in Belgium

South Korea4 sites

  • Dong-A University Hospital

    Busan, 49201

  • Kyungpook National University Hospital

    Daegu, Gyeongsangnam-do, 41944

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Asan Medical Center

    Seoul, 5505

Other trials in South Korea

Taiwan4 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10002

  • Chang Gung Memorial Hospital,Linkou

    Taoyuan, 333

Other trials in Taiwan

Croatia3 sites

  • General Hospital Varazdin

    Varaždin, Croatia Proper, 42000

  • Clinical Hospital 'Sestre Milosrdnice'

    Zagreb, Croatia Proper, 10000

  • Clinical Hospital Centar Zagreb

    Zagreb, Croatia Proper, 10000

Other trials in Croatia

Denmark3 sites

  • Copenhagen University Hospital and Glostrup Hospital

    Copenhagen, Copenhagen City, 2100

  • Bispebjerg og Frederiksberg Hospital

    Copenhagen NV, Copenhagen City, 2400

  • Sjællands Universitetshospital

    Roskilde, Østsjælland, 4000

Other trials in Denmark

Lithuania3 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, 50161

  • Republican Vilnius University Hospital, Public Institution

    Vilnius, 04130

  • Vilnius University Hospital Santariskiu Clinic, Public Institution

    Vilnius, 08661

Other trials in Lithuania

Canada2 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

Other trials in Canada

Finland2 sites

  • Helsinki University Hospital

    Helsinki, Southern, 00290 HUS

  • Turun yliopistollinen keskussairaala

    Turku, Western, 20521

Other trials in Finland

Switzerland2 sites

  • Inselspital - Universitaetsspital Bern

    Bern, 3010

  • Ospedale Regionale di Lugano

    Lugano, Canton Ticino, 6900

Other trials in Switzerland

About this study

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

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.

Being tested
BIIB093, Placebo
Keywords
Infarction, Cerebrovascular Disorders, Brain Diseases, Pathological Processes Necrosis, Central Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Glyburide, Hypoglycemic Agents, Physiological Effects of Drugs
Medical subject headings
Brain Edema, Stroke, Infarction, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIIB093Drug

    Also called glibenclamide, glibenclamide intravenous (IV), glyburide, CIRARA

    Administered as specified in the treatment arm.

  • PlaceboDrug

    Administered as specified in the treatment arm.

Study groups in NCT02864953
Study groupRoleWhat they receive
BIIB093ExperimentalBIIB093 administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
Receives: Drug: BIIB093
PlaceboPlacebo comparatorPlacebo administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS)

    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.

    Measured: Day 90

Secondary outcomes (4)

  1. Part 1: Time to All-Cause Death Through Day 90

    Time to all-cause death is defined as the time from randomization to the time of death.

    Measured: Randomization up to Day 90

  2. Part 1: Percentage of Participants Who Achieved mRS 0-4 at 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.

    Measured: Day 90

  3. Part 1: Midline Shift at 72 Hours as Assessed by Non-contrast Computed Tomography (NCCT) or Magnetic Resonance Imaging (MRI)

    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.

    Measured: At 72 hours

  4. Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    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.

    Measured: From the signing of informed consent up to the last follow-up visit (up to 4 years 11 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2016 (estimated)
  2. Study start29 Aug 2018
  3. Primary completion18 Aug 2023
  4. Study completion18 Aug 2023

Why it stopped: Early completed to operational challenges and other strategic considerations, not for efficacy or safety reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
535 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02864953
Sponsor's protocol ID
252LH301
Other IDs
RPI 301, 2017-004854-41, 2017
Acronym
CHARM
Status last verified
Nov 2024
First submitted
12 Jul 2016
Last updated
25 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sheth KN, Albers GW, Saver JL, Campbell BCV, Molyneaux BJ, Hinson HE, Cordonnier C, Steiner T, Toyoda K, Wintermark M, Littauer R, Collins J, Lucas N, Nogueira RG, Simard JM, Wald M, Dawson K, Kimberly WT; CHARM Trial investigators. Intravenous glibenclamide for cerebral oedema after large hemispheric stroke (CHARM): a phase 3, double-blind, placebo-controlled, randomised trial. Lancet Neurol. 2024 Dec;23(12):1205-1213. doi: 10.1016/S1474-4422(24)00425-3.

    PubMed 39577921

  • Shu L, Zhang W, Yaghi S, Grilli A, de Havenon A, Barrett KM, Johnston KC, Goldstein ED. Prestroke and Poststroke Sulfonylurea Exposure and Functional Outcomes: A Post Hoc Analysis of the SHINE Trial. Stroke. 2023 Sep;54(9):e415-e416. doi: 10.1161/STROKEAHA.123.043496. Epub 2023 Jul 14. No abstract available.

    PubMed 37449423

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BIIB093 in people with Brain Edema and Stroke, Acute, run by Remedy Pharmaceuticals, Inc. at 250 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 250 sites in United States, Japan, China, Germany, Spain and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS) (time frame: Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02864953, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.

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