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

Primary Purpose

Brain Edema, Stroke, Acute

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BIIB093
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Edema focused on measuring Infarction, Cerebrovascular Disorders, Brain Diseases, Pathological Processes Necrosis, Central Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Glyburide, Hypoglycemic Agents, Physiological Effects of Drugs

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Participant is likely to have supportive care withdrawn on the first day.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

Sites / Locations

  • Barrow Neurological Institute
  • Arizona Board of Regents, University of Arizona
  • Stanford Stroke Center
  • University of California Davis Health System
  • UCSD Health-La Jolla
  • University of Colorado Hospital
  • Yale New Haven Hospital
  • University of Florida-Gainsville
  • Lyerly Neurosurgery Baptist Health
  • University of Florida, Jacksonville
  • University of South Florida
  • Grady Memorial Hospital
  • Augusta University
  • The Queens Medical Center
  • Rush University Medical Center
  • University of Kansas Medical Center Research Institute, Inc.
  • University of Louisville
  • Ochsner Clinic Foundation
  • Maine Medical Center
  • University of Maryland
  • Sinai Hospital of Baltimore
  • Massachusetts General Hospital
  • Brigham and Woman's Hospital
  • Beth Israel Deaconess Medical Center, Inc.
  • UMASS Memorial Medical Center
  • Henry Ford Hospital
  • St. John's Hospital
  • Fairview Southdale Hospital
  • Saint Luke's Hospital of Kansas City
  • Saint Louis University
  • Washington University Physicians
  • JFK Medical Center
  • Jersey Shore University Medical Center
  • Rutgers - Robert Wood Johnson Medical School
  • Valley Hospital
  • University of New Mexico
  • University of Buffalo
  • Northwell Health
  • NYU Langone Medical Center
  • Mount Sinai Hospital
  • Columbia University Hervert Irving Comprehensive Cancer Center
  • University of Rochester Medical Center
  • SUNY Upstate Medical Center
  • UNC Hospitals
  • Atrium Health Carolinas Medical Center
  • Duke University Medical Center
  • Guilford Neurologic Research, PA
  • Novant Health Forsyth Medical Center
  • Wake Forest Baptist Health Sciences
  • Summa Health System
  • University of Cincinnati
  • University Hospitals Cleveland Medical Center
  • The Cleveland Clinic Foundation
  • Ohio State Univ College Of Medicine
  • Miami Valley Hospital South
  • ProMedica Toledo Hospital
  • Ascension St. John
  • Providence Brain and Spine Institute
  • Oregon Health & Science University
  • Lehigh Valley Hospital - Cedar Crest
  • Penn State University Milton S. Hershey Medical Center
  • University of Pennsylvania Health System
  • Allegheny General Hospital
  • University of Pittsburgh School of Medicine
  • Rhode Island Hospital Warren Alpert Medical School Brown University
  • Erlanger Health System
  • University of Tennessee Health Sciences Center
  • TriStar Skyline Medical Center
  • Vanderbilt Medical Center
  • St.David's HealthCare Office of Research
  • Valley Baptist Medical Center
  • University of Utah Neurology
  • University of Washington School of Medicine
  • University Hospital and UW Health Clinics
  • Liverpool Hospital
  • John Hunter Hospital
  • Royal North Shore Hospital
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Monash Medical Centre
  • The Alfred Hospital
  • Royal Melbourne Hospital
  • Sunshine Hospital
  • Universitair Ziekenhuis Gent
  • UZ Leuven
  • CHU UCL Namur
  • Clinique CHC MontLégia
  • HGF - Hospital Geral de Fortaleza
  • Hospital do Rocio
  • Hospital de Clínicas de Porto Alegre
  • Clinica Neurológica e Neurocirúrgica de Joinville
  • Hospital das Clínicas FMRP-USP
  • Hospital Sao Paulo
  • Foothills Medical Centre
  • University of Alberta Hospital
  • Anhui Provincial Hospital
  • Xuanwu Hospital Capital Medical University
  • Beijing Tiantan Hospital, Capital Medical University
  • Peking University Third Hospital
  • Beijing Tiantan Hospital, Capital Medical University
  • The First Affiliated Hospital of Sun Yat-sen University
  • The Second Affiliated Hospital of Guangzhou Medical University
  • Hainan General Hospital
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
  • Renmin Hospital, Wuhan University
  • The Second Affiliated Hospital of Soochow University
  • Huai'an First People's Hospital
  • Zhongda Hospital Southeast University
  • The Second Affiliated Hospital of Nanjing Medical University
  • Affiliated Hospital of Nantong University
  • The Affiliated Hospital of Xuzhou Medical College
  • Jiangxi Provincial People's Hospital
  • The First Affiliated Hospital of Nanchang University
  • Jiangxi Pingxiang People's Hospital
  • The First Hospital of Jilin University
  • Huashan Hospital, Fudan University
  • The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)
  • Army Specialty Medical Center of The Chinese People's Liberation Army
  • Tianjin Medical University General Hospital
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • General Hospital Varazdin
  • Clinical Hospital 'Sestre Milosrdnice'
  • Clinical Hospital Centar Zagreb
  • Fakultni nemocnice Ostrava
  • Fakultni nemocnice Brno
  • Fakultni nemocnice u sv. Anny v Brne
  • Fakultni nemocnice Kralovske Vinohrady
  • Fakultni nemocnice v Motole
  • Fakultni nemocnice Hradec Kralove
  • Bispebjerg og Frederiksberg Hospital
  • Copenhagen University Hospital and Glostrup Hospital
  • Sjællands Universitetshospital
  • Helsinki University Hospital
  • Turun yliopistollinen keskussairaala
  • CHU CAEN - Hôpital de la Côte de Nacre
  • CHU Besançon - Hôpital Jean Minjoz
  • CHU de Brest - Hôpital de la Cavale Blanche
  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin
  • CHU Rennes - Hopital Pontchaillou
  • CHU Nantes - Hopital Nord Laënnec
  • CHU Nancy - Hôpital Central
  • Hopital Roger Salengro - CHU Lille
  • Hôpital Bicêtre
  • Universitaetsklinikum Freiburg
  • Klinikum Augsburg
  • Rhon-Klnikum Campus Bad Neustadt
  • Universitaetsklinikum Erlangen
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Klinikum Frankfurt Hoechst GmbH
  • Klinikum Kassel GmbH
  • Universitaetsklinikum Essen
  • Universitaetsklinikum Muenster
  • Klinikum Altenburger Land GmbH
  • Universitaetsklinikum Jena
  • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Pest Megyei Flor Ferenc Korhaz
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Petz Aladar Egyetemi Oktato Korhaz
  • Somogy Megyei Kaposi Mor Oktato Korhaz
  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  • Semmelweis Egyetem
  • Rabin MC
  • Soroka University Medical Center
  • Rambam Health Care Center
  • Shaare Zedek
  • Hadassah University Hospital - Ein Kerem
  • Tel Aviv Sourasky Medical Center
  • Istituto Clinico Humanitas
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Policlinico Umberto I
  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  • Azienda Ospedaliera Universitaria Careggi
  • IRCCS Ospedale Policlinico San Martino
  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
  • Ospedale San Raffaele
  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
  • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • Toyota Memorial Hospital
  • Hachinohe Red Cross Hospital
  • Kimitsu Chuo Hospital
  • NHO Kyushu Medical Center
  • Chiyukai Fukuoka Wajiro Hospital
  • Chiyukai Fukuoka Shinmizumaki Hospital
  • Chiyukai Shin Yukuhashi Hospital
  • Southern Tohoku General Hospital
  • Gifu Prefectural General Medical Center
  • Showakai Brain Attack Center Ota Memorial Hospital
  • Asahikawa Red Cross Hospital
  • Ohnishi Neurological Center
  • Kobe City Hospital Organization Kobe City Medical Center General Hospital
  • Tsuchiura Kyodo General Hospital
  • Iwate Prefectural Central Hospital
  • St. Marianna University Hospital
  • NHO Sendai Medical Center
  • Kurashiki Central Hospital
  • Okayama City General Medical Center Okayama City Hospital
  • National Cerebral and Cardiovascular Center
  • Rinku General Medical Center
  • Saitama Medical University International Medical Center
  • Nippon Medical School Hospital
  • Tokyo Metropolitan Tama Medical Center
  • Kyorin University Hospital
  • NHO Minami Wakayama Medical Center
  • Yamaguchi University Hospital
  • Yamanashi Prefectural Central Hospital
  • Seoul National University Bundang Hospital
  • Kyungpook National University Hospital
  • Dong-A University Hospital
  • Asan Medical Center
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Republican Vilnius University Hospital, Public Institution
  • Vilnius University Hospital Santariskiu Clinic, Public Institution
  • Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
  • Unidade Local de Saúde de Matosinhos, E.P.E. - Hospital Pedro Hispano
  • Hospital Garcia de Orta, EPE
  • Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospitais da Universidade de Coimbra
  • Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz
  • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
  • Centro Hospitalar de São João, E.P.E
  • SPb SBIH 'City Hospital # 26'
  • Saint-Petersburg Scientific-Research Institute of Emergency Care
  • SBEI HPE 'Kazan State Medical University' of the MoH of the RF
  • SHI "Territorial Clinical Hospital #1 n.a. S.V. Ochapovsky"
  • SBIH of Moscow 'City Clinical Hospital # 1 n. a. N. I. Pirogov'
  • Hospital Universitari de Bellvitge
  • Hospital Universitario Reina Sofia
  • Complejo Hospitalario Universitario de Santiago
  • Hospital Regional Universitario de Malaga
  • Hospital del Mar
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitari de Girona Dr Josep Trueta
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario Virgen del Rocio
  • Hospital Universitario Virgen Macarena
  • Hospital Universitari i Politecnic La Fe
  • Hospital Clinico Universitario de Valladolid
  • Ospedale Regionale di Lugano
  • Inselspital - Universitaetsspital Bern
  • Kaohsiung Chang Gung Memorial Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital,Linkou
  • Addenbrooke's Hospital
  • King's College Hospital
  • Imp Coll Health Nhst 1
  • The National Hospital for Neurology & Neurosurgery
  • Nottingham University Hospitals City Campus
  • Queen Elizabeth University Hospital Campus
  • Newcastle University- Clinical Ageing Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BIIB093

Placebo

Arm Description

BIIB093 administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.

Placebo administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.

Outcomes

Primary Outcome Measures

Part 1: Percentage of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS)
mRS is a standardized interview that measures the degree of disability or dependence in the daily activities of people 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.

Secondary Outcome Measures

Part 1: Time to All-Cause Death
Part 1: Number of Participants Who Achieved mRS 0-4 at Day 90
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.
Part 1: Reduction in Midline Shift at 72 Hours
Midline shift will be assessed by non-contrast computed tomography (NCCT) or MRI.
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.

Full Information

First Posted
July 12, 2016
Last Updated
August 23, 2023
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT02864953
Brief Title
Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction
Acronym
CHARM
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Early completed to operational challenges and other strategic considerations, not for efficacy or safety reasons
Study Start Date
August 29, 2018 (Actual)
Primary Completion Date
August 18, 2023 (Actual)
Study Completion Date
August 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
537 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIIB093
Arm Type
Experimental
Arm Description
BIIB093 administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
Intervention Type
Drug
Intervention Name(s)
BIIB093
Other Intervention Name(s)
glibenclamide, glibenclamide intravenous (IV), glyburide, CIRARA
Intervention Description
Administered as specified in the treatment arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as specified in the treatment arm.
Primary Outcome Measure Information:
Title
Part 1: Percentage of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS)
Description
mRS is a standardized interview that measures the degree of disability or dependence in the daily activities of people 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.
Time Frame
Baseline up to Day 90
Secondary Outcome Measure Information:
Title
Part 1: Time to All-Cause Death
Time Frame
Baseline up to Day 90
Title
Part 1: Number of Participants Who Achieved mRS 0-4 at Day 90
Description
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.
Time Frame
Baseline up to Day 90
Title
Part 1: Reduction in Midline Shift at 72 Hours
Description
Midline shift will be assessed by non-contrast computed tomography (NCCT) or MRI.
Time Frame
Baseline up to 72 hours
Title
Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to Day 90
Other Pre-specified Outcome Measures:
Title
Part 2: mRS Score
Description
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.
Time Frame
Month 6 and 12
Title
Part 2: EuroQol 5-Level Assessment of Health Outcomes (EQ-5D-5L) Score
Description
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).
Time Frame
Month 6 and 12
Title
Part 2: Barthel Index (BI) Score
Description
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).
Time Frame
Month 6 and 12
Title
Part 2: Stroke Impact Scale 16 Questions (SIS-16) Score
Description
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).
Time Frame
Month 6 and 12
Title
Part 2: Zarit Burden Interview Score
Description
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.
Time Frame
Month 12
Title
Part 2: HealthCare Resource Utilization (HCRU) Questionnaire: Number of Participants With Visits to Healthcare Professionals for Treatment
Description
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.
Time Frame
Month 12
Title
Part 2: Number of Participants With SAEs
Description
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.
Time Frame
Up to Month 12

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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