Clinical trial NCT02446132: Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Official title: A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Agitation in Patients With Dementia of the Alzheimer's Type
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-18
Enrollment: 1197
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.

Detailed description: Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305.

Participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks).

Approximately 1200 participants will be enrolled at approximately 250 centers globally.

All participants enrolled will receive AVP-786; the treatment dose assigned will be masked to the participant, investigator, study staff, and the sponsor.

Eligibility criteria: Inclusion Criteria:

* Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.)
* Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria
* Either out-patients or residents of an assisted-living facility or a skilled nursing home
* Participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline
* Participants who delay enrollment must have a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
* Participants who delay enrollment must have a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline
* Participants who delay enrollment must have a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline

Exclusion Criteria:

* Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
* Participants determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator
* Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline

Primary outcomes:
measure: Number of Participants with any Treatment-Emergent Adverse Event
timeFrame: up to 64 weeks
measure: Number of Participants with any Treatment-Emergent Serious Adverse Event
timeFrame: up to 64 weeks
measure: Number of Participants with any abnormal, clinically significant Clinical Laboratory Value
timeFrame: up to 52 weeks
measure: Number of Participants with any abnormal, clinically significant 12-lead Electrocardiogram (ECG) value
timeFrame: up to 52 weeks
measure: Number of Participants with any abnormal, clinically significant Physical and Neurological Examination finding
timeFrame: up to 52 weeks
measure: Number of participants with any abnormal, clinically significant vital sign value
timeFrame: up to 52 weeks
measure: Change from Baseline to Week 64 in the Sheehan Suicidality Tracking Scale (S-STS) Score
timeFrame: Baseline; Week 64
measure: Change from Baseline to Week 52 in the Mini-Mental State Examination (MMSE) Score
timeFrame: Baseline; Week 52
measure: Change from Baseline to Week 52 in the Epworth Sleepiness Scale (ESS) Score
timeFrame: Baseline; Week 52
Secondary outcomes:
measure: Change from Baseline to Week 64 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score
timeFrame: Baseline; Week 64
measure: Change from Baseline to Week 52 in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI)
timeFrame: Baseline; Week 52
measure: Change from Baseline to Week 64 in the modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score
timeFrame: Baseline; Week 64
measure: Change from Baseline to Week 52 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score
timeFrame: Baseline; Week 52
measure: Change from Baseline to Week 52 in the Patient Global Impression of Change (PGIC) Score
timeFrame: Baseline; Week 52
measure: Change from Baseline to Week 52 in the Dementia Quality of Life (DEMQOL) Score
timeFrame: Baseline; Week 52
measure: Change from Baseline to Week 52 in the Resource Utilization in Dementia (RUD) Score
timeFrame: Baseline; Week 52
measure: Change from Baseline to Week 52 in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) for Participants from Study 17-AVP-786-305
timeFrame: Baseline; Week 52
Other outcomes:
measure: Number of participants using concomitant medications
timeFrame: up to 64 weeks
Locations:
city: Chandler
country: United States
facility: MD First Research, LLC Site #767
state: Arizona
city: Phoenix
country: United States
facility: NoesisPharma, LLC
state: Arizona
city: Scottsdale
country: United States
facility: Perseverance Research Center, LLC
state: Arizona
city: Fayetteville
country: United States
facility: Health Initiatives Research
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center, Inc. Site #835
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc. Site #763
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Irvine
country: United States
facility: Irvine Center for Clinical Research
state: California
city: Lakewood
country: United States
facility: Sheenath Clinical Service Site #770
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute, Inc. Site #826
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC.
state: California
city: Long Beach
country: United States
facility: Alliance for Wellness, Inc dba Alliance for Research Site #789
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Panorama City
country: United States
facility: California Neurological Services
state: California
city: Pasadena
country: United States
facility: Havana Research Institute Site 787
state: California
city: Pasadena
country: United States
facility: Havana Research Institute
state: California
city: San Diego
country: United States
facility: Pacific Research Network, Inc. #1
state: California
city: San Diego
country: United States
facility: Pacific Research Network, Inc. #2
state: California
city: Santa Ana
country: United States
facility: HB Clinical Trials Inc.
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Temecula
country: United States
facility: Viking Clinical Research
state: California
city: Denver
country: United States
facility: Lytle and Weiss, PLLC dba Clinical Trials of the Rockies
state: Colorado
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: Norwalk
country: United States
facility: Research Center for Clinical Studies, Inc.
state: Connecticut
city: Altamonte Springs
country: United States
facility: Neurology of Central Florida Rsch Ctr Site #803
state: Florida
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Aventura
country: United States
facility: Negron Research Services / Humanity Clinical Research Site# 766
state: Florida
city: Boca Raton
country: United States
facility: SFM Clinical Research, LLC Site #563
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center Site #834
state: Florida
city: Brandon
country: United States
facility: Clinical Research Of Brandon, LLC Site #838
state: Florida
city: Brandon
country: United States
facility: Clinical Research of Brandon
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Deerfield Beach
country: United States
facility: Quantum Laboratories, Inc.
state: Florida
city: Doral
country: United States
facility: Moonshine Research Center, Inc
state: Florida
city: Doral
country: United States
facility: Science Connections, LLC Site #814
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research Corp
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center #801
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc.
state: Florida
city: Hialeah
country: United States
facility: New Life Medical Research Center, Inc.
state: Florida
city: Hialeah
country: United States
facility: Reliable Clinical Research,LLC
state: Florida
city: Hialeah
country: United States
facility: Research in Miami, Inc
state: Florida
city: Hialeah
country: United States
facility: The Research Center, Inc
state: Florida
city: Hialeah
country: United States
facility: Berma Research Group
state: Florida
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Hialeah
country: United States
facility: Maxblue Institute
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Jupiter
country: United States
facility: Alphab Global Research #793
state: Florida
city: Kissimmee
country: United States
facility: SIH Research, LLC
state: Florida
city: Lake Worth
country: United States
facility: Alzheimer's Research and Treatment Center #1
state: Florida
city: Lake Worth
country: United States
facility: Alzheimer's Research and Treatment Center #2
state: Florida
city: Lake Worth
country: United States
facility: Alzheimer's Research and Treatment Center #3
state: Florida
city: Lakeland
country: United States
facility: Meridien Research Site #558
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc. Site #819
state: Florida
city: Miami Gardens
country: United States
facility: New Med Research, Inc Site #812
state: Florida
city: Miami
country: United States
facility: Homestead Associates in Research Site# 797
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute, Inc. #1
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute, Inc. #2
state: Florida
city: Miami
country: United States
facility: Central Miami Medical Institute Site #798
state: Florida
city: Miami
country: United States
facility: Global Medical Institutes, LLC
state: Florida
city: Miami
country: United States
facility: Optimus U Corp
state: Florida
city: Miami
country: United States
facility: Project 4 Research #1
state: Florida
city: Miami
country: United States
facility: Project 4 Research #2
state: Florida
city: Miami
country: United States
facility: BioMed Research Institute
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research Corp Site #552
state: Florida
city: Miami
country: United States
facility: First Class Medical Services Site #807
state: Florida
city: Miami
country: United States
facility: CCM Clinical Research Group
state: Florida
city: Miami
country: United States
facility: Innova Clinical Trials
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Center #1
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Center #2
state: Florida
city: Miami
country: United States
facility: Dade Research Center Llc
state: Florida
city: Miami
country: United States
facility: Vitae Researrch Center LLC
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health Systems, Inc.
state: Florida
city: Miami
country: United States
facility: United Health Research Corp. #1
state: Florida
city: Miami
country: United States
facility: United Health Research Corp. #2
state: Florida
city: Miami
country: United States
facility: Advanced Medical Center Group
state: Florida
city: Miami
country: United States
facility: Future Care Solution, LLC
state: Florida
city: Miami
country: United States
facility: Reliant Medical Research LLC Site #811
state: Florida
city: Miami
country: United States
facility: Hope Research Network LLC Site #773
state: Florida
city: Miami
country: United States
facility: Clinical Research Associates of South Florida #1
state: Florida
city: Miami
country: United States
facility: Clinical Research Associates of South Florida #2
state: Florida
city: Miami
country: United States
facility: Coral Research Clinic Corp
state: Florida
city: Miami
country: United States
facility: P&S RESEARCH, LLC. Site #805
state: Florida
city: Miami
country: United States
facility: Pharmax Research of South Florida
state: Florida
city: Miami
country: United States
facility: Kendall Research Institute
state: Florida
city: Miami
country: United States
facility: Nuovida Research Center Corp.
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists, LLC
state: Florida
city: Naples
country: United States
facility: Naples Research, Inc
state: Florida
city: New Port Richey
country: United States
facility: Bayside Clinical Research Site #556
state: Florida
city: Oakland Park
country: United States
facility: Research Centers of America, LLC
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando Site #799
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC Inc.
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center Site #802
state: Florida
city: Pensacola
country: United States
facility: University of West Florida
state: Florida
city: Port Charlotte
country: United States
facility: Neurostudies Inc. Site#796
state: Florida
city: Sarasota
country: United States
facility: Roskamp Institute
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Tampa
country: United States
facility: VICIS Clinical Research Inc. Site #777
state: Florida
city: The Villages
country: United States
facility: Compass Research North, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Neurology Research Institute Palm Beach, LLC #1
state: Florida
city: West Palm Beach
country: United States
facility: Neurology Research Institute Palm Beach, LLC #2
state: Florida
city: Winter Park
country: United States
facility: Florida Premier Research Institute
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research Inc
state: Georgia
city: Columbus
country: United States
facility: Columbus Research & Wellness Institute, INC
state: Georgia
city: Columbus
country: United States
facility: Medical Research & Health Education Foundation, Inc.
state: Georgia
city: Decatur
country: United States
facility: NeuroStudies. Net, LLC
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology, PC
state: Indiana
city: Lenexa
country: United States
facility: MidAmerica Neuroscience Research Foundation
state: Kansas
city: Paducah
country: United States
facility: Four Rivers Clinical Research Inc.
state: Kentucky
city: Easton
country: United States
facility: The Samuel & Alexia Bratton Memory Clinic
state: Maryland
city: Hagerstown
country: United States
facility: Mir Neurology
state: Maryland
city: Braintree
country: United States
facility: Alzheimer Disease Center Site #804
state: Massachusetts
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Quincy
country: United States
facility: Alzheimer's Disease Center
state: Massachusetts
city: Caro
country: United States
facility: Onyx Clinical Research, LLC
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University Department of Neurology
state: Michigan
city: Troy
country: United States
facility: Oakland Medical Research Site #762
state: Michigan
city: Chesterfield
country: United States
facility: Galen Research
state: Missouri
city: Creve Coeur
country: United States
facility: Millennium Psychiatric Associates, LLC
state: Missouri
city: Mount Arlington
country: United States
facility: The NeuroCognitive Institute
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Brooklyn
country: United States
facility: Integrative Clinical Trials LLC #1
state: New York
city: Brooklyn
country: United States
facility: Integrative Clinical Trials LLC #2
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine, PLLC
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical Center, LLC
state: New York
city: Orangeburg
country: United States
facility: Nathan S. Kline Institute for Psychiatric Research #1
state: New York
city: Orangeburg
country: United States
facility: Nathan S. Kline Institute for Psychiatric Research #571
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: White Plains
country: United States
facility: Burke Rehabilitation Hospital
state: New York
city: Chapel Hill
country: United States
facility: Herbert Harris, Md, Phd, Pa
state: North Carolina
city: Charlotte
country: United States
facility: ANI Neurology PLLC dba Alzheimer's Memory Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Akron
country: United States
facility: Neurology and Neuroscience Associates, Inc.
state: Ohio
city: Beachwood
country: United States
facility: Insight Clinical Trials, LLC Site #570
state: Ohio
city: Centerville
country: United States
facility: Valley Medical Research Site #788
state: Ohio
city: Centerville
country: United States
facility: Valley Medical Research
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Lakewood
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health at Lakewood Hospital
state: Ohio
city: Middleburg Heights
country: United States
facility: NorthStar Medical Research Site #778
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Clinical Research Center
state: Oklahoma
city: Beaver
country: United States
facility: Heritage Valley Medical Group, Inc.
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Neurological Associates, LTD
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Charleston
country: United States
facility: RH Johnson VA Medical Center
state: South Carolina
city: Charleston
country: United States
facility: Roper St. Francis Healthcare
state: South Carolina
city: Spartanburg
country: United States
facility: BG Neurology
state: South Carolina
city: Dallas
country: United States
facility: Texas Neurology, P.A.
state: Texas
city: Dallas
country: United States
facility: Neurology Consultants of Dallas, PA
state: Texas
city: Dallas
country: United States
facility: University Texas Southwestern Medical Center
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research Site #576
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist Neurological Institute
state: Texas
city: Mesquite
country: United States
facility: PRX Research Site #825
state: Texas
city: San Antonio
country: United States
facility: Texas Medical Research Associates, L.L.C.
state: Texas
city: Clinton
country: United States
facility: Ericksen Research and Development
state: Utah
city: Salt Lake City
country: United States
facility: Pharmaceuticals Research Associates, Inc.
state: Utah
city: Bennington
country: United States
facility: Clinical Neuroscience Research Associates, Inc. dba The Memory Clinic
state: Vermont
city: Woodstock
country: United States
facility: Neuropsychiatric Associates
state: Vermont
city: Salem
country: United States
facility: Veteran Affairs Medical Center, Salem Virginia
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Everett
country: United States
facility: Core Clinical Research Site #772
state: Washington
city: Waukesha
country: United States
facility: IPC Research
state: Wisconsin
city: Ruse
country: Bulgaria
facility: Center for Mental Health - Ruse
city: Sofia
country: Bulgaria
facility: Mental Health Centre Prof. Nikola Shipkovenski Site #713
city: Sofia
country: Bulgaria
facility: Medical Center Sveti Naum Site #707
city: Sofia
country: Bulgaria
facility: Vrach and Sv. Sv. Kuzma and Damian Site #710
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Alexandrovska Site #704
city: Varna
country: Bulgaria
facility: Medical Center Mladost-M
city: Veliko Tarnovo
country: Bulgaria
facility: Medica Plus Medical Center
city: Penticton
country: Canada
facility: Dr. Alexander McIntyre Inc.
city: Brno
country: Czechia
facility: Fakultni Nemocnice u sv. Anny v Brne Site #722
city: Hradec Kralové
country: Czechia
facility: Fakultní Nemocnice Hradec Králové Site #724
city: Hradec Kralové
country: Czechia
facility: NeuropsychiatrieHK Site #729
city: Kladno
country: Czechia
facility: Brain-Soultherapy
city: Kutna Hora
country: Czechia
facility: Námestí národního odboje 692 Site #723
city: Plzen
country: Czechia
facility: A-Shine s.r.o. Site #731
city: Praha
country: Czechia
facility: AD71
city: Praha
country: Czechia
facility: Clintrial
city: Praha
country: Czechia
facility: Neurologicka Ambulance - Forbeli
city: Praha
country: Czechia
facility: Neuropsychiatrie Site #726
city: Rychnov nad Kněžnou
country: Czechia
facility: Vestra Clinics
city: Saint-Etienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord Site #535
state: Auvergne-Rhone-Alpes
city: Dijon Cedex
country: France
facility: Centre Hospitalier Universitaire Dijon Bourgogn Site #536
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire Toulouse - Casselardit Ancely Site #533
city: Balassagyarmat
country: Hungary
facility: Dr. Kenessey Albert Kórház-Rendelőintézet
city: Budapest
country: Hungary
facility: Pszichiatriai es Pszichiatriai Rehabilitacios Osztaly Site #586
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
city: Kalocsa
country: Hungary
facility: Dr. Mathe es Tarsa Beteti Tarsasag Site #593
city: Pécs
country: Hungary
facility: PsychoTech Clinical Research Site# 580
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea Site #606
city: Roma
country: Italy
facility: Fondazione Policlinico Tor Vergata Site #609
city: Roma
country: Italy
facility: Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico
city: Nowa Sól
country: Poland
facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol Site #757
state: Lubuskie
city: Sochaczew
country: Poland
facility: RCMed Oddział Sochaczew Site #510
state: Mazowieckie
city: Bydgoszcz
country: Poland
facility: Ksiedza Hugona Kollataja 9
city: Katowice
country: Poland
facility: Care Clinic Clinical Research Site #750
city: Katowice
country: Poland
facility: Wielospecjalistyczna Poradnia Lekarska Synapsis Site #741
city: Kraków
country: Poland
facility: Krakowska Akademia Neurologii Site #740
city: Kraków
country: Poland
facility: Malopolskie Centrum Medyczne Site #747
city: Lodz
country: Poland
facility: Medycyna Milorzab Site #743
city: Poznań
country: Poland
facility: Solumed Centrum Medyczne Site #753
city: Szczecin
country: Poland
facility: Centrum Medyczne Euromedis
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect Site #742
city: Zabrze
country: Poland
facility: ClinHouse Centrum Medyczne
city: Cape Town
country: South Africa
facility: ACF Neurological Services
city: Cape Town
country: South Africa
facility: Cape Trial Centre
city: Cape Town
country: South Africa
facility: Flexivest Fourteen Research Centre
city: Johannesburg
country: South Africa
facility: Apollo Clinical Research Site #623
city: Rosebank
country: South Africa
facility: Medical and Dental Centre
city: Alcobendas
country: Spain
facility: Accellacare Alcobendas
city: Barcelona
country: Spain
facility: Fundació ACE
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena Site #649
city: Zamora
country: Spain
facility: Complejo Asistencial de Zamora Hospital Virgen de la Concha
city: Zaragoza
country: Spain
facility: Hospital Viamed Montecanal Site #643
Study officials:
References: