Clinical trial NCT06585787: A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease
AD
ADEPT4
ADEPT-4
KarXT
Psychosis
Lead sponsor: Karuna Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 406
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.


Eligibility criteria: Inclusion Criteria

* Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
* Patients who are diagnosed with AD based on the 2024 National Institute on Aging - Alzheimer's Association criteria with AD biomarker confirmation.
* Patient must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma.
* Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).

Exclusion Criteria

- Patients will not be able to participate if they have:.

i) Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.

ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.

iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.

* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
timeFrame: Up to Week 14
Secondary outcomes:
measure: Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale
timeFrame: Up to Week 14
measure: Change from baseline in Neuropsychiatric Inventory-Clinician (NPI-C) Core score: Hallucination Domain
timeFrame: Up to Week 14
measure: Change from baseline in NPI-C Core score: Delusion Domain
timeFrame: Up to Week 14
measure: Change from baseline in NPI-C Core score: Agitation Domain
timeFrame: Up to Week 14
measure: Change from baseline in NPI-C Core score: Aggression Domain
timeFrame: Up to Week 14
measure: Change from baseline in NPI-C Agitation score
timeFrame: Up to Week 14
measure: Change from baseline in NPI-C Core score: Caregiver Distress Scale
timeFrame: Up to Week 14
measure: Number of participants with a ≥ 40% improvement from Baseline in NPI-C: H+D score
timeFrame: Up to Week 14
measure: Change from baseline in Cohen- Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score
timeFrame: Up to Week 14
measure: Change from baseline in Cohen- Mansfield Agitation Inventory (CMAI) total score
timeFrame: Up to Week 14
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to Week 14
measure: Number of participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 14
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to Week 14
measure: Number of participants with TEAEs leading to study withdrawal
timeFrame: Up to Week 14
measure: Number of participants with procholinergic symptoms
timeFrame: Up to Week 14
measure: Number of participants with anticholinergic symptoms
timeFrame: Up to Week 14
measure: Number of participants with AEs of Special Interest (AESIs)
timeFrame: Up to Week 14
measure: Barnes Akathisia Rating Scale (BARS) Score
timeFrame: Up to Week 14
measure: Abnormal Involuntary Movement Scale (AIMS) Score
timeFrame: Up to Week 14
measure: Body Weight
timeFrame: Up to Week 14
measure: Body Mass Index (BMI)
timeFrame: Up to Week 14
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Week 14
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Week 14
measure: Number of participants with 12-lead electrocardiogram (ECG) abnormalities
timeFrame: Up to Week 14
measure: Number of participants with suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to Week 14
measure: Cognition as assessed by the Mini-Mental State Examination (MMSE)
timeFrame: Up to Week 14
measure: Cognition as assessed by the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13)
timeFrame: Up to Week 14
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Chandler Clinical Trials, LLC
state: Arizona
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Long Beach
country: United States
facility: Long Beach Research Institute, LLC
state: California
city: Los Angeles
country: United States
facility: Local Institution - 1226
state: California
city: Los Angeles
country: United States
facility: Local Institution - 1219
state: California
city: Orange
country: United States
facility: ATP Clinical Research-302 W La Veta Ave
state: California
city: Orange
country: United States
facility: NRC Research Institute - Orange - PPDS
state: California
city: Pasadena
country: United States
facility: SC3 Research - Pasadena - 960 E. Green St
state: California
city: Rancho Cucamonga
country: United States
facility: Prospective Research Innovations 8577 Haven Ave
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Atlantis
country: United States
facility: Genesis Trust Research Group
state: Florida
city: Bonita Springs
country: United States
facility: Envision Trials LLC
state: Florida
city: Cutler Bay
country: United States
facility: JY Research Institute Inc
state: Florida
city: Daytona Beach
country: United States
facility: Arrow Clinical Trials
state: Florida
city: Deerfield Beach
country: United States
facility: Quantum Laboratories, Inc - West Palm Beach Office
state: Florida
city: Doral
country: United States
facility: Integrity Clinical Research, LLC - 8000 NW 21st St
state: Florida
city: Hialeah
country: United States
facility: New Life Medical Research Center -3750 W 16th Ave
state: Florida
city: Hialeah
country: United States
facility: Research in Miami, Inc
state: Florida
city: Homestead
country: United States
facility: Nexus Clinical Research Center- NRC
state: Florida
city: Lady Lake
country: United States
facility: K2 Medical Research - Lady Lake
state: Florida
city: Miami Gardens
country: United States
facility: New Med Research
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Angels Clinical Research Institute - Miami Lakes
state: Florida
city: Miami
country: United States
facility: Homestead Associates in Research Inc
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute - Miami - ClinEdge - PPDS
state: Florida
city: Miami
country: United States
facility: Dade Research Center
state: Florida
city: Miami
country: United States
facility: Wellness Research Center Inc - Miami
state: Florida
city: Miami
country: United States
facility: A & D Doctor Center
state: Florida
city: Miami
country: United States
facility: Floridian Neuroscience Institute-1901 SW 1 St
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health Systems
state: Florida
city: Miami
country: United States
facility: MedOne Clinical Research LLC
state: Florida
city: Miami
country: United States
facility: My Community Research Center, Inc - 7480 Bird Rd
state: Florida
city: Miami
country: United States
facility: Future Care Solution LLC
state: Florida
city: Miami
country: United States
facility: Reliant Medical Research
state: Florida
city: Miami
country: United States
facility: Novel Clinical Research Center, LLC.
state: Florida
city: Miami
country: United States
facility: US Associates in Research Inc
state: Florida
city: Miami
country: United States
facility: Serenity Research Center
state: Florida
city: Miami
country: United States
facility: IMIC LLC- 9380 SW 150th Str
state: Florida
city: Miami
country: United States
facility: New Gen Health
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute-1021 Ives Dairy Rd
state: Florida
city: Miami
country: United States
facility: High Quality Research
state: Florida
city: Ocoee
country: United States
facility: Sensible HealthCare, LLC - ClinEdge - PPDS
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando Phase I-IV
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research (Duplicate)
state: Florida
city: Sweetwater
country: United States
facility: Cordova Research Institute- Sweetwater
state: Florida
city: Tampa
country: United States
facility: Angels Clinical Research Institute Tampa
state: Florida
city: Tampa
country: United States
facility: Interventional Psychiatry of Tampa Bay
state: Florida
city: Wellington
country: United States
facility: Local Institution - 1233
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute at Palm Beach Neurology, PA
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Local Institution - 1239
state: Massachusetts
city: Flowood
country: United States
facility: Precise Research Centers - ClinEdge - PPDS
state: Mississippi
city: Toms River
country: United States
facility: Advanced Memory Research Institute - CenExel - PPDS
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Syracuse
country: United States
facility: Local Institution - 1231
state: New York
city: Syracuse
country: United States
facility: Local Institution - 1240
state: New York
city: Woodmere
country: United States
facility: Five Towns Neurology, PC
state: New York
city: Greensboro
country: United States
facility: Triad Clinical Trials
state: North Carolina
city: Matthews
country: United States
facility: AMC Research, LLC - Flourish - PPDS
state: North Carolina
city: Morehead City
country: United States
facility: Local Institution - 5005
state: North Carolina
city: Morehead City
country: United States
facility: West Clinical Research
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution - 1242
state: Oklahoma
city: Providence
country: United States
facility: Alzheimer's Disease and Memory Disorders Center at Rhode Island Hospital
state: Rhode Island
city: Nashville
country: United States
facility: Local Institution - 1211
state: Tennessee
city: DeSoto
country: United States
facility: Epic Medical Research LLC - DeSoto
state: Texas
city: El Paso
country: United States
facility: Advanced Neuro Research Center - El Paso
state: Texas
city: Plano
country: United States
facility: Local Institution - 1238
state: Texas
city: San Antonio
country: United States
facility: Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
state: Texas
city: Stafford
country: United States
facility: R & H Clinical Research-3727 Greenbriar Dr
state: Texas
city: Arlington
country: United States
facility: Local Institution - 1241
state: Virginia
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 5004
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 5005
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 5001
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution - 5006
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution - 5002
city: Cordoba
country: Argentina
facility: Local Institution - 5003
city: San Rafael
country: Argentina
facility: Local Institution - 5007
city: Jette
country: Belgium
facility: UZ Brussel - PPDS
state: Brussels
city: Roeselare
country: Belgium
facility: AZ Delta- Campus Rumbeke
state: West-Vlaanderen
city: Alken
country: Belgium
facility: ANIMA Research Center - PPDS
city: Brugge
country: Belgium
facility: Local Institution - 2807
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Brasília
country: Brazil
facility: Local Institution - 6201
state: Distrito Federal
city: São Paulo
country: Brazil
facility: Local Institution - 6202
state: SAO Paulo
city: São Paulo
country: Brazil
facility: Local Institution - 6206
state: SAO Paulo
city: São Paulo
country: Brazil
facility: Local Institution - 6205
state: SAO Paulo
city: São Paulo
country: Brazil
facility: Local Institution - 6203
state: SAO Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 6204
city: Sofia
country: Bulgaria
facility: Local Institution - 4506
state: Sofia-Grad
city: Plovdiv
country: Bulgaria
facility: Local Institution - 4508
city: Ruse
country: Bulgaria
facility: Local Institution - 4507
city: Sofia
country: Bulgaria
facility: Local Institution - 4509
city: Zagreb
country: Croatia
facility: Polyclinic Neuron
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
state: GRAD Zagreb
city: Zagreb
country: Croatia
facility: Klinika za psihijatriju Vrapce
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Psychiatric Clinic Sveti Ivan
state: Grad Zagreb
city: Nice
country: France
facility: Institut Claude Pompidou
state: Alpes-Maritimes
city: Tours
country: France
facility: Local Institution - 2511
state: Indre-et-Loire
city: Toulouse
country: France
facility: Local Institution - 2512
city: Toulouse
country: France
facility: CHU de Toulouse- Gerontopole
city: Böblingen
country: Germany
facility: Local Institution - 2407
state: Baden-Württemberg
city: Erbach
country: Germany
facility: NeuroCentrum Odenwald
state: Hessen
city: Homburg
country: Germany
facility: Universitatsklinikum des Saarlandes
state: Saarland
city: Berlin
country: Germany
facility: Local Institution - 2406
city: Frankfurt am Main
country: Germany
facility: Local Institution - 2405
city: Athina
country: Greece
facility: Henry Dunant Hospital Center
state: Attiki
city: Chaidari, Athens
country: Greece
facility: Local Institution - 4802
state: Attiki
city: Kalyftaki-N. Kifissia
country: Greece
facility: Local Institution - 4810
state: Attiki
city: Heraklion
country: Greece
facility: PAGNI-University General Hospital of Heraklion
state: Irakleio
city: Thessaloniki
country: Greece
facility: 424 General Military Training Hospital-Outpatient Psychiatric Department
city: Pécs
country: Hungary
facility: Psychotech Kft.
state: Baranya
city: Szeged
country: Hungary
facility: Local Institution - 4610
state: Csongrád
city: Gyöngyös
country: Hungary
facility: Clinexpert Gyöngyös Kft.
state: Heves
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Pszichiátriai és Pszichoterápiás Klinika
city: Budapest
country: Hungary
facility: Eszak-budai Szent Janos Centrumkorhaz
city: Hyderabad
country: India
facility: Local Institution - 7403
state: Andhra Pradesh
city: Nagpur
country: India
facility: Local Institution - 7401
state: Maharashtra
city: Kolkata
country: India
facility: Local Institution - 7404
state: West Bengal
city: Varanasi
country: India
facility: Local Institution - 7402
city: Ashkelon
country: Israel
facility: The Barzilai University Medical Center
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center- Ein Kerem - PPDS
state: Yerushalayim
city: Petah Tikva
country: Israel
facility: Rabin Medical Center - PPDS
city: Ramat -Gan
country: Israel
facility: The Chaim Sheba Medical Center - PPDS
city: Roma
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I - Viale del Policlinico 155
state: Lazio
city: Roma
country: Italy
facility: IRCCS San Raffaele- Via di Val Cannuta 250
state: Lazio
city: Brescia
country: Italy
facility: IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
state: Lombardia
city: Milano
country: Italy
facility: Auxologico IRCCS - Auxologico San Luca
state: Lombardia
city: Ponderano (Biella)
country: Italy
facility: ASL Biella - Ospedale degli Infermi
state: Piemonte
city: Rome
country: Italy
facility: Local Institution - 2321
state: Roma
city: Roma
country: Italy
facility: Azienda Ospedaliero-Universitaria Sant'Andrea
city: Iizuka
country: Japan
facility: Iizuka Memorial Hospital
state: Fukuoka
city: Koriyama
country: Japan
facility: Local Institution - 7525
state: Fukushima
city: Sapporo
country: Japan
facility: Teine Keijinkai Hospital
state: Hokkaido
city: Himeji-Shi
country: Japan
facility: Hyogo Prefectural Harima-Himeji General Medical Center
state: Hyogo
city: Toride-shi
country: Japan
facility: Memory Clinic Toride
state: Ibaraki
city: Takamatsu-Shi
country: Japan
facility: Kagawa Prefectural Central Hospital
state: Kagawa
city: Hadano
country: Japan
facility: Hatano Kousei Hospital
state: Kanagawa
city: Kawasaki-Shi
country: Japan
facility: Koukan Clinic
state: Kanagawa
city: Yokohama-Shi
country: Japan
facility: Yokohama City Minato Red Cross Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Tsurumi Nishii Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Kyoto-Shi
country: Japan
facility: National Hospital Organization Utano National Hospital
state: Kyoto
city: Tsu-Shi
country: Japan
facility: National Hospital Organization Miechuo Medical Center
state: MIE
city: Sakai
country: Japan
facility: Asakayama General Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Shin-Abuyama Hospital
state: Osaka
city: Kanzaki-Gun Yoshinogari-Cho
country: Japan
facility: Local Institution - 7510
state: Saga
city: Wako-Shi
country: Japan
facility: Local Institution - 7504
state: Saitama
city: Yoshinogawa
country: Japan
facility: NHO Tokushima Medical Center West
state: Tokushima
city: Hachioji
country: Japan
facility: Tokyo Angel Hospital
state: Tokyo
city: Setagaya-Ku
country: Japan
facility: Sangenjaya Nakamura Mental Clinic
state: Tokyo
city: Setagaya-Ku
country: Japan
facility: Kurumi Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Local Institution - 7515
city: Hiroshima
country: Japan
facility: Funairi nou clinic
city: Kumamoto
country: Japan
facility: Yuge Neuropsychiatric Hospital
city: Tatebayashi
country: Japan
facility: Tsutsujimental Hospital
city: Ansan-si
country: Korea, Republic of
facility: Local Institution - 7214
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Local Institution - 7217
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Local Institution - 7215
state: Seoul Teugbyeolsi
city: Yeongdeungpo-Gu
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
state: Seoul Teugbyeolsi
city: Gangwon-do
country: Korea, Republic of
facility: Local Institution - 7218
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Yongin-si
country: Korea, Republic of
facility: Local Institution - 7216
city: Wroclaw
country: Poland
facility: 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
state: Dolnoslaskie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17
state: Pomorskie
city: Ilawa
country: Poland
facility: Local Institution - 4207
state: Warminsko-mazurskie
city: Kielce
country: Poland
facility: Local Institution - 4213
city: Lodz
country: Poland
facility: Pro Salus Sp. z o.o.sp. k
city: Lublin
country: Poland
facility: NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska -Lublin
city: Poznan
country: Poland
facility: Centrum Medyczne HCP Szpital im. Jana Pawla II
city: Guimarães
country: Portugal
facility: ULS do Alto Ave, EPE - Hospital da Senhora da Oliveira Guimarães
state: Braga
city: Lisbon
country: Portugal
facility: ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
state: Lisboa
city: Torres Vedras
country: Portugal
facility: Campus Neurológico Sénior
state: Lisboa
city: Matosinhos
country: Portugal
facility: ULS de Matosinhos, EPE - Hospital Pedro Hispano
state: Porto
city: Lisboa
country: Portugal
facility: ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
city: Lisboa
country: Portugal
facility: Local Institution - 2706
city: Bayamon
country: Puerto Rico
facility: Santa Cruz Behavioral PSC
city: Bayamon
country: Puerto Rico
facility: CDT Grupo Medico San Pablo Inc.
city: San Juan
country: Puerto Rico
facility: Instituto De Neurologia Dra. Ivonne Fraga,Psc
city: San Juan
country: Puerto Rico
facility: Barbara Diaz Hernandez MD Research Inc
city: San Juan
country: Puerto Rico
facility: Local Institution - 1305
city: Oradea
country: Romania
facility: CMI Dr. Buhas Ramocea Elena Daniela - Cabinet Medical de Psihiarie
state: Bihor
city: Bucuresti
country: Romania
facility: Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- Centrul de Sanatate Mintala
city: Constanta
country: Romania
facility: Cai Ferate Clinical Hospital Constanta
city: Craiova
country: Romania
facility: Institutul Privat de Cercetări Melchisedec pentru Boli Autoimune, Ereditare și Rare -I.P.C.M
city: Iasi
country: Romania
facility: Local Institution - 4905
city: Sibiu
country: Romania
facility: S.C. Carpe Diem SRL
city: Beograd
country: Serbia
facility: University Clinical Center of Serbia - Dr Subotica 6 - PPDS
state: Belgrade
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Dragisa Misovic Dedinje
city: Belgrade
country: Serbia
facility: Local Institution - 4308
city: Belgrade
country: Serbia
facility: Local Institution - 4314
city: Gornja Toponica
country: Serbia
facility: Special Hospital for Psychiatric Diseases Gornja Toponica
city: Kovin
country: Serbia
facility: Special Hospital for Psychiatric Diseases Kovin
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina
city: Kosice
country: Slovakia
facility: Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43
state: Košický Kraj
city: Banska Bystrica
country: Slovakia
facility: MUDr. Beata Dupejova - Neurologicka Ambulancia s.r.o
city: Dubnica nad Váhom
country: Slovakia
facility: KONZILIUM s.r.o
city: Košice
country: Slovakia
facility: EPAMED s.r.o
city: Pezinok
country: Slovakia
facility: Psychiatrická nemocnica Philippa Pinela Pezinok
city: Vranov nad Topľou
country: Slovakia
facility: Crystal Comfort, s.r.o.
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
state: Madrid
city: Lleida
country: Spain
facility: Hospital Universitari Santa Maria
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Salamanca
country: Spain
facility: Hospital Universitario De Salamanca
city: Sevilla
country: Spain
facility: Hospital Victoria Eugenia
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
city: Atakum
country: Turkey
facility: Local Institution - 4702
state: Samsun
city: Ankara
country: Turkey
facility: Local Institution - 4706
city: Eskisehir
country: Turkey
facility: Local Institution - 4701
city: Istanbul
country: Turkey
facility: Local Institution - 4704
city: Izmir
country: Turkey
facility: Local Institution - 4705
city: Izmir
country: Turkey
facility: Local Institution - 4703
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: