Clinical trial NCT03444870: Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-02-23
Enrollment: 1053
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.


Eligibility criteria: Key Inclusion criteria:

* Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment)
* Evidence of the AD pathological process, as confirmed by CSF tau/A-beta42or amyloid PET scan
* Demonstrated abnormal memory function
* MMSE score greater than or equal to 22 (≥ 22)
* Clinical dementia rating-global score (CDR-GS) of 0.5 or 1.0
* Availability of a reliable study partner who accepts to participate in study procedures throughout the 2 years duration of study
* If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening and until randomization
* For enrollment in the China extension, patients must have residence in mainland China, Hong Kong, or Taiwan and be of Chinese ancestry
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods

Key Exclusion criteria:

* Any evidence of a condition other than AD that may affect cognition
* History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
* History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function
* History or presence of clinically evident cerebrovascular disease
* History or presence of posterior reversible encephalopathy syndrome
* History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 6 months of an acute event that is consistent with a transient ischemic attack
* History of severe, clinically significant CNS trauma
* History or presence of intracranial mass (e.g., glioma, meningioma) that could potentially impair cognition
* Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae
* History or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits
* At risk for suicide in the opinion of the investigator
* Alcohol and/or substance abuse or dependants in past 2 years
* Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
* Any contraindications to brain MRI
* Unstable or clinically significant cardiovascular, kidney or liver disease
* Uncontrolled hypertension
* Unstable or clinically significant cardiovascular disease
* Abnormal thyroid function
* Patients with evidence of folic acid deficiency

Exclusion for Open-Label Extension (OLE):

* Discontinued from study treatment during the double-blind treatment period
* Received any other investigational medication during the double-blind treatment period or after the end of double-blind treatment
* Participation in the OLE deemed inappropriate by the investigator
* Presence of ARIA-E findings at the Week 116 MRI scan

Primary outcomes:
measure: DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB
timeFrame: Baseline, Week 116
measure: China Extension: DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB
timeFrame: Baseline, Week 116
Secondary outcomes:
measure: DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score
timeFrame: Baseline, Week 116
measure: DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) Total Score
timeFrame: Baseline, Week 116
measure: DBT Period: Change From Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score
timeFrame: Baseline, Week 116
measure: DBT Period: Change From Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score
timeFrame: Baseline, Week 116
measure: DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 11 (ADAS-Cog11) Score
timeFrame: Baseline, Week 116
measure: DBT Period: Change From Baseline to Week 116 in Verbal Fluency Task (VFT) Score
timeFrame: Baseline, Week 116
measure: DBT Period: Change From Baseline to Week 116 in the Coding (Digit Symbol Substitution Test [DSST]) Subtest
timeFrame: Baseline, Week 116
measure: DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) Instrumental Score
timeFrame: Baseline, Week 116
measure: DBT Period: Number of Participants With at Least One Adverse Event (AE)
timeFrame: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
measure: DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
measure: DBT Period: Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Magnetic Resonance Imaging (MRI) Finding
timeFrame: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
measure: DBT Period: Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) MRI Finding
timeFrame: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
measure: DBT Period: Number of Participants With Injection-Site Reactions
timeFrame: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
measure: DBT Period: Number of Participants With Anti-Drug Antibodies (ADA) to Gantenerumab
timeFrame: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
measure: DBT Period: Change From Baseline to Week 116 in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan in a Subset of Participants
timeFrame: Baseline, Week 116
measure: DBT Period: Change From Baseline to Week 116 in Brain Tau Load, as Measured by Tau PET Scan in a Subset of Participants
timeFrame: Baseline, Week 116
measure: DBT Period: Percent Change From Baseline to Week 116 in Cerebrospinal Fluid (CSF) Marker of Disease in a Subset of Participants - Total Tau (tTau)
timeFrame: Baseline, Week 116
measure: DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Phosphorylated Tau (pTau-181)
timeFrame: Baseline, Week 116
measure: DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Neurofilament Light Chain (NFL)
timeFrame: Baseline, Week 116
measure: DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Neurogranin
timeFrame: Baseline, Week 116
measure: China - DBT Period: Change From Baseline to Week 116 in ADAS-Cog13 Score
timeFrame: Baseline, Week 116
measure: China - DBT Period: Change From Baseline to Week 116 in ADCS-ADL Total Score
timeFrame: Baseline, Week 116
measure: China - DBT Period: Change From Baseline to Week 116 in FAQ Score
timeFrame: Baseline, Week 116
measure: China - DBT Period: DBT Period: Change From Baseline to Week 116 in MMSE Total Score
timeFrame: Baseline, Week 116
measure: China - DBT Period: Change From Baseline to Week 116 in ADAS-Cog11 Score
timeFrame: Baseline, Week 116
measure: China - DBT Period: Change From Baseline to Week 116 in VFT Score
timeFrame: Baseline, Week 116
measure: China - DBT Period: Change From Baseline to Week 116 in the Coding (DSST) Subtest
timeFrame: Baseline, Week 116
measure: China - DBT Period: Number of Participants With at Least One AE
timeFrame: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
measure: China - DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
timeFrame: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
measure: China - DBT Period: Number of Participants With at Least One ARIA-E MRI Finding
timeFrame: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
measure: China - DBT Period: Number of Participants With at Least One ARIA-H MRI Finding
timeFrame: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
measure: China - DBT Period: Number of Participants With Injection-Site Reactions
timeFrame: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
measure: OLE Period: Number of Participants With at Least One AEs
timeFrame: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)
measure: OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
timeFrame: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)
measure: OLE Period: Number of Participants With at Least One ARIA-H MRI Finding
timeFrame: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)
measure: OLE Period: Number of Participants With at Least One ARIA-E MRI Finding
timeFrame: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Irvine
country: United States
facility: Global Clinical Trials; Irvine, CA
state: California
city: Sacramento
country: United States
facility: Sutter Medical Group, Neurology
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc
state: California
city: Norwalk
country: United States
facility: Research Center for Clinical Studies, Inc.
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research LLC
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research, Inc.
state: Florida
city: Wellington
country: United States
facility: Alzheimer?s Research and Treatment Center
state: Florida
city: Columbus
country: United States
facility: Columbus Memory Center
state: Georgia
city: Gainesville
country: United States
facility: Center for Advanced Research & Education
state: Georgia
city: Springfield
country: United States
facility: Southern Illinois University, School of Medicine
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Wichita
country: United States
facility: Via Christi Research
state: Kansas
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Toms River
country: United States
facility: Advanced Memory Research Institute of NJ
state: New Jersey
city: Lake Success
country: United States
facility: Neurological Associates of Long Island, PC
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Columbus
country: United States
facility: Ohio State University; College of Medicine
state: Ohio
city: Abington
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University; College of Medicine
state: Pennsylvania
city: Port Royal
country: United States
facility: Coastal Neurology
state: South Carolina
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Dallas
country: United States
facility: Neurology Consultants of Dallas; Research Department
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Neurology Specialists
state: Virginia
city: Richmond
country: United States
facility: Neurological Associates, Inc.
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research Inc.-Richmond
state: Virginia
city: Madison
country: United States
facility: UW Wisconsin-Madison
state: Wisconsin
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney; Neurology
state: New South Wales
city: Erina
country: Australia
facility: Central Coast Neurosciences Research
state: New South Wales
city: Kogarah
country: Australia
facility: Southern Neurology
state: New South Wales
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital; Neurology
state: South Australia
city: Heidelberg West
country: Australia
facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
state: Victoria
city: Noble Park
country: Australia
facility: Neuro Trials Victoria
state: Victoria
city: Nedlands
country: Australia
facility: Australian Alzheimer's Research Foundation
state: Western Australia
city: Curitiba
country: Brazil
facility: Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia
state: PR
city: Curitiba
country: Brazil
facility: Instituto de Neurologia de Curitiba
state: PR
city: Maringa
country: Brazil
facility: Clinica Clinilive ltda
state: PR
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Sao Paulo
country: Brazil
facility: Clínica Dr. Norton Sayeg LTDA - EPP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP_X; Neurologia
state: SP
city: Penticton
country: Canada
facility: Medical Arts Health Research Group
state: British Columbia
city: Vancouver
country: Canada
facility: The Medical Arts Health Research Group - West Vancouver
state: British Columbia
city: London
country: Canada
facility: Parkwood Hospital; Geriatric Medicine
state: Ontario
city: Toronto
country: Canada
facility: Centre for Memory and Aging
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael'S Hospital
state: Ontario
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
city: Woodstock
country: Canada
facility: Devonshire Clinical Research
state: Ontario
city: Greenfield Park
country: Canada
facility: Center for Diagnosis and Research on Alzheimer's disease
state: Quebec
city: Sherbrooke
country: Canada
facility: Q & T Research Sherbrooke
state: Quebec
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Beijing City
country: China
facility: China-Japan Friendship Hospital
city: Beijing City
country: China
facility: Beijing Anding Hospital, Capital Medical University
city: Beijing City
country: China
facility: Beijing Tian Tan Hospital,Capital Medical University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: The First Affiliated Hospital, Chongqing Medical University
city: Fuzhou City
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou City
country: China
facility: Guangdong Provincial People's Hospital; Breast
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital; Neurology
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
city: Hangzhou City
country: China
facility: Sir Run Run Shaw Hospital
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Nanchang
country: China
facility: The Second Affiliated Hospital to Nanchang University
city: Nanjing City
country: China
facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
city: Nanjing City
country: China
facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
city: Nanjing
country: China
facility: Zhongda Hospital Affiliated to Southeast University
city: Shanghai City
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
city: Shanghai City
country: China
facility: Huashan Hospital Affiliated to Fudan University
city: Shanghai
country: China
facility: Shanghai Mental Health Center
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Shenzhen City
country: China
facility: The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical College
city: Yangzhou City
country: China
facility: Northern Jangsu People's Hospital
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Amiens Cedex1
country: France
facility: CHU Amiens Hopital Sud; Neurologie
city: Bobigny Cedex
country: France
facility: Hôpital Avicenne; Centre de Recherche Clinique
city: Bron cedex
country: France
facility: Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)
city: Marseille
country: France
facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie
city: Paris
country: France
facility: Hôpital Lariboisière
city: Poitiers
country: France
facility: CHU Poitiers - Hopital La Miletrie
city: Strasbourg
country: France
facility: CHU Strasbourg Hôpital Hautepierre
city: Toulouse
country: France
facility: Gerontopole; Centre de Recherche clinique
city: Villeurbanne
country: France
facility: Hopital des Charpennes
city: Berlin
country: Germany
facility: Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin
city: Berlin
country: Germany
facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
city: Bochum
country: Germany
facility: St. Josef-Hospital, Klinik für Neurologie
city: Köln
country: Germany
facility: Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie
city: Leipzig
country: Germany
facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH
city: Mainz
country: Germany
facility: Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
city: Münster
country: Germany
facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock Zentrum für Nervenheilkunde
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm; Klinik für Neurologie
city: Westerstede
country: Germany
facility: Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
city: Witten
country: Germany
facility: Forschungszentrum Ruhr
city: Budapest
country: Hungary
facility: Semmelweis University; Department of Neurology
city: Modena
country: Italy
facility: Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica
state: Lazio
city: Roma
country: Italy
facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza
state: Lazio
city: Roma
country: Italy
facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
state: Lazio
city: Brescia
country: Italy
facility: IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer
state: Lombardia
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria
state: Lombardia
city: Monza
country: Italy
facility: ASST DI MONZA; Neurologia
state: Lombardia
city: Pozzilli
country: Italy
facility: IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
state: Molise
city: Torino
country: Italy
facility: AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria
state: Piemonte
city: Palermo
country: Italy
facility: Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
state: Sicilia
city: Chiba
country: Japan
facility: Medical Corporation Hakuyokai Kashiwado Hospital
city: Chiba
country: Japan
facility: Inage Neurology and Memory Clinic
city: Chiba
country: Japan
facility: Juntendo University Urayasu Hospital
city: Fukushima
country: Japan
facility: Southern Tohoku Medical Clinic
city: Kanagawa
country: Japan
facility: Yuai Clinic
city: Kanagawa
country: Japan
facility: Shonan Kamakura General Hospital
city: Niigata
country: Japan
facility: Mishima Hospital
city: Shizuoka
country: Japan
facility: NHO Shizuoka Institute of Epilepsy and Neurological Disorders
city: Shizuoka
country: Japan
facility: Shizuoka City Shimizu Hospital
city: Tochigi
country: Japan
facility: Jichiidai Station Brain Clinic
city: Tokyo
country: Japan
facility: Yotsuya Medical Cube
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Geriatric Hospital
city: Tokyo
country: Japan
facility: Nozomi Memory Clinic
city: Tokyo
country: Japan
facility: National Center of Neurology and Psychiatry
city: Tokyo
country: Japan
facility: P-One Clinic
city: Yamagata
country: Japan
facility: Yamagata Tokusyukai Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinics; Neurology
city: Bellavista
country: Peru
facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
city: Lima
country: Peru
facility: Clinica Internacional; Unidad De Investigacion
city: Lima
country: Peru
facility: Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
city: San Martin de Porres
country: Peru
facility: Hospital Nacional Cayetano Heredia; Servicio de Neurologia
city: Krasnoyarsk
country: Russian Federation
facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
state: Krasnojarsk
city: Moscow
country: Russian Federation
facility: University ?linic of headaches
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: City Clin Hosp n.a. S.P.Botkin
state: Moskovskaja Oblast
city: Moskva
country: Russian Federation
facility: Central Clinical Hospital #2 N.A. Semashko OAO RJHD
state: Moskovskaja Oblast
city: St Petersburg
country: Russian Federation
facility: Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department
state: Sankt Petersburg
city: Kazan
country: Russian Federation
facility: Vertebronevrologiya LLC
state: Tatarstan
city: Kazan
country: Russian Federation
facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center
state: Tatarstan
city: Saratov
country: Russian Federation
facility: City Clinical Hospital # 2 n.a. V.I. Razumovsky
city: Tomsk
country: Russian Federation
facility: Nebbiolo Center for Clinical Trials
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge; Servicio de Neurologia
state: Barcelona
city: Sant Cugat del Valles
country: Spain
facility: Hospital General De Catalunya; Servicio de Neurologia
state: Barcelona
city: SANtander
country: Spain
facility: Hospital Universitario Marques de Valdecilla; Servicio de Neurología
state: Cantabria
city: Logroño
country: Spain
facility: Hospital San Pedro; Servicio de Neurología
state: LA Rioja
city: Móstoles
country: Spain
facility: HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría
state: Madrid
city: Albacete
country: Spain
facility: Hospital General Universitario de Albacete; Servicio de Neurología
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron; Servicio de Neurología
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial; Servicio de Neurologia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Neurologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Neurologia
city: Madrid
country: Spain
facility: Hospital Ruber Internacional; Servicio de Neurología
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío; Servicio de Neurología
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset; Servicio de Neurologia
city: Zaragoza
country: Spain
facility: Servicio de Neurología Hospital Viamed Montecanal.
city: Changhua County
country: Taiwan
facility: Changhua Christian Hospital; Neurology
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital; Neurology
city: Niaosong Dist.
country: Taiwan
facility: Chang Gung Memorial Foundation - Kaohsiung - Neurology
city: North Dist.
country: Taiwan
facility: China Medical University Hospital; Neurology
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital; Neurology
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Foundation - Linkou - Neurology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: