Clinical trial NCT02864953: Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Brain Edema
Stroke, Acute
Keywords: Infarction
Cerebrovascular Disorders
Brain Diseases
Pathological Processes Necrosis
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Lead sponsor: Remedy Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-12
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS)
timeFrame: Day 90
Secondary outcomes:
measure: Part 1: Time to All-Cause Death Through Day 90
timeFrame: Randomization up to Day 90
measure: Part 1: Percentage of Participants Who Achieved mRS 0-4 at Day 90
timeFrame: Day 90
measure: Part 1: Midline Shift at 72 Hours as Assessed by Non-contrast Computed Tomography (NCCT) or Magnetic Resonance Imaging (MRI)
timeFrame: At 72 hours
measure: Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From the signing of informed consent up to the last follow-up visit (up to 4 years 11 months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Tucson
country: United States
facility: Arizona Board of Regents, University of Arizona
state: Arizona
city: Palo Alto
country: United States
facility: Stanford Stroke Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Health System
state: California
city: San Diego
country: United States
facility: UCSD Health-La Jolla
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida-Gainsville
state: Florida
city: Jacksonville
country: United States
facility: Lyerly Neurosurgery Baptist Health
state: Florida
city: Jacksonville
country: United States
facility: University of Florida, Jacksonville
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Honolulu
country: United States
facility: The Queens Medical Center
state: Hawaii
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute, Inc.
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Woman's Hospital
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Beth Israel Deaconess Medical Center, Inc.
state: Massachusetts
city: Worcester
country: United States
facility: UMASS Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: St. John's Hospital
state: Michigan
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Physicians
state: Missouri
city: Edison
country: United States
facility: JFK Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers - Robert Wood Johnson Medical School
state: New Jersey
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University Hervert Irving Comprehensive Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Guilford Neurologic Research, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Sciences
state: North Carolina
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State Univ College Of Medicine
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital South
state: Ohio
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Tulsa
country: United States
facility: Ascension St. John
state: Oklahoma
city: Portland
country: United States
facility: Providence Brain and Spine Institute
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital - Cedar Crest
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State University Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital Warren Alpert Medical School Brown University
state: Rhode Island
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Health Sciences Center
state: Tennessee
city: Nashville
country: United States
facility: TriStar Skyline Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Austin
country: United States
facility: St.David's HealthCare Office of Research
state: Texas
city: Harlingen
country: United States
facility: Valley Baptist Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Neurology
state: Utah
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
city: Madison
country: United States
facility: University Hospital and UW Health Clinics
state: Wisconsin
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: East Flanders
city: Leuven
country: Belgium
facility: UZ Leuven
state: Flemish Brabant
city: Yvoir
country: Belgium
facility: CHU UCL Namur
state: Namur
city: Liege
country: Belgium
facility: Clinique CHC MontLégia
city: Fortaleza
country: Brazil
facility: HGF - Hospital Geral de Fortaleza
state: Ceará
city: Campo Largo
country: Brazil
facility: Hospital do Rocio
state: Paraná
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Clinica Neurológica e Neurocirúrgica de Joinville
state: Santa Catarina
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clínicas FMRP-USP
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital Sao Paulo
state: Sao Paulo
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Bejing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital, Wuhan University
state: Hubei
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsushe
city: Huai'an
country: China
facility: Huai'an First People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)
state: Shanxi
city: Chongqing
country: China
facility: Army Specialty Medical Center of The Chinese People's Liberation Army
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Varazdin
country: Croatia
facility: General Hospital Varazdin
state: Croatia Proper
city: Zagreb
country: Croatia
facility: Clinical Hospital 'Sestre Milosrdnice'
state: Croatia Proper
city: Zagreb
country: Croatia
facility: Clinical Hospital Centar Zagreb
state: Croatia Proper
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
state: Moravian-Silesian
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
state: Moravia
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
state: Moravia
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
state: Prague
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
state: Prague
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Copenhagen NV
country: Denmark
facility: Bispebjerg og Frederiksberg Hospital
state: Copenhagen City
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital and Glostrup Hospital
state: Copenhagen City
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital
state: Østsjælland
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Southern
city: Turku
country: Finland
facility: Turun yliopistollinen keskussairaala
state: Western
city: Caen cedex 9
country: France
facility: CHU CAEN - Hôpital de la Côte de Nacre
state: Calvados
city: Besancon Cedex
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
state: Doubs
city: Brest cedex 2
country: France
facility: CHU de Brest - Hôpital de la Cavale Blanche
state: Finistere
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin
state: Gironde
city: Rennes cedex 09
country: France
facility: CHU Rennes - Hopital Pontchaillou
state: Ille-et-Vilaine
city: Saint-Herblain
country: France
facility: CHU Nantes - Hopital Nord Laënnec
state: Loire Atlantique
city: Nancy
country: France
facility: CHU Nancy - Hôpital Central
state: Meurthe Et Moselle
city: Lille Cedex
country: France
facility: Hopital Roger Salengro - CHU Lille
state: Nord
city: Le Kremlin Bicêtre cedex
country: France
facility: Hôpital Bicêtre
state: Val De Marne
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
state: Baden Wuerttemberg
city: Augsburg
country: Germany
facility: Klinikum Augsburg
state: Bayern
city: Bad Neustadt Saale
country: Germany
facility: Rhon-Klnikum Campus Bad Neustadt
state: Bayern
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
state: Bayern
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
state: Hessen
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt Hoechst GmbH
state: Hessen
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH
state: Hessen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
state: Nordrhein Westfalen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
state: Nordrhein Westfalen
city: Altenburg
country: Germany
facility: Klinikum Altenburger Land GmbH
state: Thueringen
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
state: Thueringen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
state: Budapest
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
state: Csongrád-Csanád
city: Gyor
country: Hungary
facility: Petz Aladar Egyetemi Oktato Korhaz
state: Győr-Moson-Sopron
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz
state: Somogy
city: Nyiregyhaza
country: Hungary
facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
state: Szabolcs-Szatmár-Bereg
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Petah Tikva
country: Israel
facility: Rabin MC
state: Central
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
state: Southern
city: Haifa
country: Israel
facility: Rambam Health Care Center
city: Jerusalem
country: Israel
facility: Shaare Zedek
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
state: Roma
city: Rome
country: Italy
facility: Policlinico Umberto I
state: Roma
city: Rome
country: Italy
facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
state: Roma
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Milano
country: Italy
facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria alle Scotte
city: Toyota-shi
country: Japan
facility: Toyota Memorial Hospital
state: Aichi-Ken
city: Hachinohe-shi
country: Japan
facility: Hachinohe Red Cross Hospital
state: Aomori-Ken
city: Kisarazu-shi
country: Japan
facility: Kimitsu Chuo Hospital
state: Chiba-Ken
city: Fukuoka-shi
country: Japan
facility: NHO Kyushu Medical Center
state: Fukuoka-Ken
city: Fukuoka-shi
country: Japan
facility: Chiyukai Fukuoka Wajiro Hospital
state: Fukuoka-Ken
city: Onga-gun
country: Japan
facility: Chiyukai Fukuoka Shinmizumaki Hospital
state: Fukuoka-Ken
city: Yukuhashi-shi
country: Japan
facility: Chiyukai Shin Yukuhashi Hospital
state: Fukuoka-Ken
city: Koriyama-shi
country: Japan
facility: Southern Tohoku General Hospital
state: Fukushima-Ken
city: Gifu-shi
country: Japan
facility: Gifu Prefectural General Medical Center
state: Gifu-Ken
city: Fukuyama-shi
country: Japan
facility: Showakai Brain Attack Center Ota Memorial Hospital
state: Hiroshima-Ken
city: Asahikawa-shi
country: Japan
facility: Asahikawa Red Cross Hospital
state: Hokkaido
city: Akashi-shi
country: Japan
facility: Ohnishi Neurological Center
state: Hyogo-Ken
city: Kobe-shi
country: Japan
facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital
state: Hyogo-Ken
city: Tsuchiura-shi
country: Japan
facility: Tsuchiura Kyodo General Hospital
state: Ibaraki-Ken
city: Morioka-shi
country: Japan
facility: Iwate Prefectural Central Hospital
state: Iwate-Ken
city: Kawasaki-shi
country: Japan
facility: St. Marianna University Hospital
state: Kanagawa-Ken
city: Sendai-shi
country: Japan
facility: NHO Sendai Medical Center
state: Miyagi-Ken
city: Kurashiki-shi
country: Japan
facility: Kurashiki Central Hospital
state: Okayama-Ken
city: Okayama-shi
country: Japan
facility: Okayama City General Medical Center Okayama City Hospital
state: Okayama-Ken
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka Prefecture
city: Izumisano-shi
country: Japan
facility: Rinku General Medical Center
state: Osaka-Fu
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama-Ken
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo-To
city: Fuchu-shi
country: Japan
facility: Tokyo Metropolitan Tama Medical Center
state: Tokyo-To
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital
state: Tokyo-To
city: Tanabe-shi
country: Japan
facility: NHO Minami Wakayama Medical Center
state: Wakayama-Ken
city: Ube-shi
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi-Ken
city: Kofu-shi
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi-Ken
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Gyeongsangnam-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
city: Vilnius
country: Lithuania
facility: Republican Vilnius University Hospital, Public Institution
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinic, Public Institution
city: Santa Maria da Feira
country: Portugal
facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
state: Aveiro
city: Matosinhos
country: Portugal
facility: Unidade Local de Saúde de Matosinhos, E.P.E. - Hospital Pedro Hispano
state: Porto
city: Almada
country: Portugal
facility: Hospital Garcia de Orta, EPE
state: Setubal
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospitais da Universidade de Coimbra
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar de São João, E.P.E
city: Saint Petersburg
country: Russian Federation
facility: SPb SBIH 'City Hospital # 26'
state: Leningrad
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg Scientific-Research Institute of Emergency Care
state: Leningrad
city: Kazan
country: Russian Federation
facility: SBEI HPE 'Kazan State Medical University' of the MoH of the RF
state: Respublka Tatarstan
city: Krasnodar
country: Russian Federation
facility: SHI "Territorial Clinical Hospital #1 n.a. S.V. Ochapovsky"
city: Moscow
country: Russian Federation
facility: SBIH of Moscow 'City Clinical Hospital # 1 n. a. N. I. Pirogov'
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Córdoba
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: La Coruña
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
state: Málaga
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr Josep Trueta
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
state: Ticino
city: Bern
country: Switzerland
facility: Inselspital - Universitaetsspital Bern
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital,Linkou
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
city: London
country: United Kingdom
facility: King's College Hospital
state: Greater London
city: London
country: United Kingdom
facility: Imp Coll Health Nhst 1
state: Greater London
city: London
country: United Kingdom
facility: The National Hospital for Neurology & Neurosurgery
state: Greater London
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals City Campus
state: Nottinghamshire
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital Campus
state: Strathclyde
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle University- Clinical Ageing Research Unit
state: Tyne & Wear
Study officials:
affiliation: Remedy Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References: