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Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Primary Purpose

Agitation in Patients With Dementia of the Alzheimer's Type

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
AVP-786
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agitation in Patients With Dementia of the Alzheimer's Type focused on measuring Agitation, Dementia of the Alzheimer's type, Alzheimer's disease, AVP-786, Deudextromethorphan hydrobromide, Quinidine sulfate

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
  • Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to baseline that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator
  • The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.
  • A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of ≥ 4 (moderately ill) at screening and baseline
  • Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.
  • Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

Exclusion Criteria:

  • Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
  • Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)
  • 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 with myasthenia gravis

Sites / Locations

  • MD First Research #767
  • Liv Generations of Agritopia / CCT
  • Liv Generations of Ahwatukee / CCT
  • Perseverance Research Center
  • Medical Advancement Center of Arizona
  • Clinical Trials Inc.
  • Advanced Research Center, Inc
  • ATP Clinical Research, Inc
  • Paradigm Clinical Research Centers, Inc.
  • Sunwise Clinical Research
  • Torrance Clinical Research Institute, Inc.
  • Rohun Medical Corporation Site #770
  • Alliance for Wellness, Inc dba Alliance for Research
  • Havana Research Institute
  • Neurology of Central Florida Rsch Ctr # 803
  • Negron Research Services / Humanity Clinical Research
  • SFM Clinical Research, LLC
  • Helix Biomedics LLC
  • Bradenton Research Center
  • Clinical Research of Brandon
  • ASCLEPES Research Center #806
  • Beautiful Minds Clinical Research Center #808
  • Science Connections, LLC
  • ConSalud Medical Research
  • Direct Helpers Research Center # 801
  • New Med Research Inc #812
  • Alphab Global Research
  • Alzheimer's Research and Treatment Center
  • Meridien Research - Lakeland Site Site #558
  • Zynak Clinical Services
  • Adaptive Clinical Research, Inc. Site# 815
  • Innovative Clinical Research, Inc Site #819
  • Crystal Biomedical Research, LLC
  • Agility Medical Research, Inc Site #816
  • Homestead Associates in Research #797
  • Premier Clinical Research Institute, Inc.
  • Central Miami Medical Institute # 798
  • Project4Research #774
  • City Medical Group RC
  • Finlay Medical Research Corp
  • First Class Medical Services #807
  • Miami Jewish Health Systems, Inc.
  • New Horizon Research Center Site #795
  • Reliant Medical Research, LLC #811
  • Clinical Research Associates of South Florida
  • P&S Research, LLC #805
  • Pharmax Research of South Florida
  • Research Institute of West Kendall
  • Bayside Clinical Research
  • Combined Research Orlando #799
  • Innovation Medical Research Center #801
  • Quantum Laboratories Site #768
  • Neurostudies Inc. Site# 796
  • VICIS Clinical Research Inc.
  • Academic Alliance in Dermatology
  • JSV Clinical Research Study, Inc.
  • NeuroStudies. Net, LLC
  • Hawaii Pacific Neuroscience
  • DelRicht Research #776
  • Alzheimer Disease Center #804
  • Neurobehavioral Medicine Group
  • Onyx Clinical Research, LLC
  • Oakland Medical Research #762
  • Precise Research Centers Site #765
  • Galen Research Site #550
  • Psychiatric Care and Research Center
  • Bio Behavioral Health
  • Mid Hudson Medical Research, PLLC
  • Nathan S. Kline Institute for Psychiatric Research
  • Five Towns Neurology PC/Village Site #764
  • The Neurological Institute
  • New Hope Clinical Research
  • Insight Clinical Trials LLC
  • Valley Medical Research Site#788
  • OSUMC
  • NorthStar Medical Research
  • Onyx Clinical Research, LLC
  • Newton Clinical Research
  • Orenda Research & Consulting LLC
  • Keystone Clinical Studies, LLC
  • Trinity Universal Research Associates Site #821
  • Texas Neurology
  • InSite Clinical Research
  • Bio Pharma Informatic LLC Site#822
  • Bio Pharma Informatic Inc Site #769
  • Katy Neurology
  • Northpointe Psychiatry
  • Wellness Clinical Research
  • PRX Research Site#825
  • Wasatch Clinical Research, LLC Site #771
  • Northwest Clinical Research Center
  • Core Clinical Research # 772
  • IPC Research
  • Australian Alzheimer's Research Foundation
  • Neuro Trials Victoria Pty Ltd
  • The Alfred Hospital
  • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski
  • Medical Center Hipokrat-N EOOD
  • Center for Mental Health - Ruse
  • Mental Health Centre Prof.Nikola Shipkovenski #713
  • DCC "Sv. Vrach and Sv. Sv. Kuzma and Damian" OOD
  • First Multiprofile Hospital for Active Treatment Sofia
  • Medical Center Stimul
  • Medical Center Sveti Naum
  • University Multiprofile Hospital for Active Treatment Alexandrovska
  • Diagnostic-consultative center Mladost-М Varna OOD #711
  • Medica Plus Medical Center
  • Mental Health Center Site #712
  • MUDr. Marta Holanová Site# 733
  • Fakultni Nemocnice u sv. Anny v Brne #722
  • Clinline Services s.r.0 Psychiatricka ambulance
  • Fakultní Nemocnice Hradec Králové #724
  • NeuropsychiatrieHK #729
  • Brain-Soultherapy #728
  • Supervize #723
  • A-Shine s.r.o.
  • Ad71 #727
  • Clintrial #720
  • INEP Medical s.r.o. Institut Neuropsychiatricke Pece
  • Neurologicka Ambulance - Forbeli #721
  • Neuropsychiatrie #726
  • Vestra Clinics #725
  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
  • Centre Hospitalier de Calais
  • Centre Hospitalier Universitaire Dijon Bourgogn
  • Centre Hospitalier Universitaire de Nantes - Hôpital Nord Laennec
  • Centre Hospitalier Universitaire de Poitiers
  • Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord
  • Centre Hospitalier Universitaire Toulouse - Casselardit Ancely
  • Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
  • Dr. Kenessey Albert Kórház-Rendelőintézet
  • Semmelweis Egyetem Site#595
  • Semmelweis Egyetem
  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
  • Valeomed Egeszsegugyi es Szolgaltato Kft
  • Petz Aladár Egyetemi Oktató Kórház Site# 594
  • Dr. Mathe es Tarsa Beteti Tarsasa Site #593
  • CRU Hungary Egészségügyi és Szolgáltató Korlátolt Felelősségű Társaság
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
  • PsychoTech
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Fejér Megyei Szent György Egyetemi Oktató Kórház
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  • Centro San Giovanni di Dio - Fatebenefratelli
  • Università degli studi G.D'Annunzio Chieti Pescara
  • Azienda Ospedaliero - Universitaria Careggi
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Azienda Ospedaliera San Gerardo di Monza
  • Azienda Sanitaria Locale di Biella - Nuovo Ospedale degli Infermi
  • Azienda Ospedaliera Sant'Andrea
  • Fondazione Policlinico Tor Vergata
  • Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico
  • Śródmieście Przychodnia - Bydgoszcz
  • Centrum Medyczne Sensemed
  • Care Clinic
  • Wielospecjalistyczna Poradnia Lekarska Synapsis #741
  • Krakowska Akademia Neurologii
  • Pratia MCM Kraków
  • Medycyna Milorzab #743
  • Twoja Przychodnia - Centrum Medyczne Nowa Sol #757
  • Neurologiczny Niepubliczny Zakład Opieki Zdrowotnej
  • Centrum Medyczne HCP
  • Solumed Centrum Medyczne #753
  • RCMed Oddział Sochaczew #510
  • Amonaria Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda
  • Centrum Medyczne Euromedis
  • Przychodnia Specjalistyczna Prosen Site#758
  • Centrum Medyczne NeuroProtect
  • Centrum Medyczne Pratia Warszawa
  • ClinHouse Centrum Medyczne #755
  • Ośrodek Alzheimerowski #756
  • ACF Neurological Services
  • Cape Trial Centre
  • Flexivest Fourteen Research Centre
  • Apollo Clinical Research
  • Medical and Dental Centre
  • Dr. Chisto Carel Coetzee
  • Accellacare Alcobendas #659
  • Fundació ACE
  • Fundació Hospital de la Santa Creu i Sant Pau
  • Hospital Clinic de Barcelona
  • Hospital Universitari Vall d'Hebrón
  • Hospital Universitario Reina Sofia
  • Hospital General Universitario de Elche
  • Hospital Universitari de Santa Maria
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Universitario Puerta de Hierro - Majadahonda
  • Clínica Universidad de Navarra
  • Hospital Universitario de Salamanca
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario y Politécnico de La Fe
  • Complejo Asistencial de Zamora Hospital Virgen de la Concha
  • Hospital Viamed Montecanal
  • MAC Clinical Research - Barnsley Site #671
  • Research Institute for the Care of Older People
  • Belfast Health and Social Care Trust
  • MAC Clinical Research - Blackpool
  • MAC Clinical Research - Cannock
  • MAC Clinical Research - Leeds
  • Re:Cognition Health - London
  • South London and Maudsley NHS Foundation Trust
  • MAC Clinical Research - Manchester
  • Northamptonshire Healthcare NHS Foundation Trust
  • MAC Clinical Research - Liverpool
  • Southern Health NHS Foundation Trust
  • Avon and Wiltshire Mental Health Partnership NHS Trust
  • North West Boroughs Healthcare NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

AVP-786; Dose 1

AVP-786; Dose 2

Arm Description

Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.

Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.

Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.

Outcomes

Primary Outcome Measures

Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score

Secondary Outcome Measures

Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score

Full Information

First Posted
January 3, 2018
Last Updated
October 9, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03393520
Brief Title
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

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
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.
Detailed Description
Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD. This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment. Approximately 550 participants will be enrolled at approximately 90 centers worldwide. Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation in Patients With Dementia of the Alzheimer's Type
Keywords
Agitation, Dementia of the Alzheimer's type, Alzheimer's disease, AVP-786, Deudextromethorphan hydrobromide, Quinidine sulfate

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.
Arm Title
AVP-786; Dose 1
Arm Type
Experimental
Arm Description
Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.
Arm Title
AVP-786; Dose 2
Arm Type
Experimental
Arm Description
Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral capsules
Intervention Type
Drug
Intervention Name(s)
AVP-786
Intervention Description
oral capsules
Primary Outcome Measure Information:
Title
Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score
Time Frame
Baseline; Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score
Time Frame
Baseline; Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to baseline that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group. A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of ≥ 4 (moderately ill) at screening and baseline Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study. Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant. Exclusion Criteria: Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia) Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium) 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 with myasthenia gravis
Facility Information:
Facility Name
MD First Research #767
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85286
Country
United States
Facility Name
Liv Generations of Agritopia / CCT
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85296
Country
United States
Facility Name
Liv Generations of Ahwatukee / CCT
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85048
Country
United States
Facility Name
Perseverance Research Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Medical Advancement Center of Arizona
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Clinical Trials Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Advanced Research Center, Inc
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
ATP Clinical Research, Inc
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc.
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Sunwise Clinical Research
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Facility Name
Torrance Clinical Research Institute, Inc.
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Rohun Medical Corporation Site #770
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
Alliance for Wellness, Inc dba Alliance for Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Havana Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Neurology of Central Florida Rsch Ctr # 803
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32714
Country
United States
Facility Name
Negron Research Services / Humanity Clinical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
SFM Clinical Research, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Helix Biomedics LLC
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33436
Country
United States
Facility Name
Bradenton Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Clinical Research of Brandon
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
ASCLEPES Research Center #806
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Beautiful Minds Clinical Research Center #808
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Science Connections, LLC
City
Doral
State/Province
Florida
ZIP/Postal Code
33178
Country
United States
Facility Name
ConSalud Medical Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Direct Helpers Research Center # 801
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
New Med Research Inc #812
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33020
Country
United States
Facility Name
Alphab Global Research
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Alzheimer's Research and Treatment Center
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Meridien Research - Lakeland Site Site #558
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Zynak Clinical Services
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Facility Name
Adaptive Clinical Research, Inc. Site# 815
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Innovative Clinical Research, Inc Site #819
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Crystal Biomedical Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Agility Medical Research, Inc Site #816
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Homestead Associates in Research #797
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
Premier Clinical Research Institute, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Central Miami Medical Institute # 798
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Project4Research #774
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
City Medical Group RC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Finlay Medical Research Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
First Class Medical Services #807
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Miami Jewish Health Systems, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
New Horizon Research Center Site #795
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Reliant Medical Research, LLC #811
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Clinical Research Associates of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
P&S Research, LLC #805
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Pharmax Research of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Research Institute of West Kendall
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Bayside Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Combined Research Orlando #799
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Facility Name
Innovation Medical Research Center #801
City
Palmetto
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Quantum Laboratories Site #768
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Neurostudies Inc. Site# 796
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
VICIS Clinical Research Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Academic Alliance in Dermatology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
JSV Clinical Research Study, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
NeuroStudies. Net, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Hawaii Pacific Neuroscience
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
DelRicht Research #776
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70443
Country
United States
Facility Name
Alzheimer Disease Center #804
City
Braintree
State/Province
Massachusetts
ZIP/Postal Code
02184
Country
United States
Facility Name
Neurobehavioral Medicine Group
City
Bloomfield
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Facility Name
Onyx Clinical Research, LLC
City
Caro
State/Province
Michigan
ZIP/Postal Code
48723
Country
United States
Facility Name
Oakland Medical Research #762
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Precise Research Centers Site #765
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Galen Research Site #550
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Psychiatric Care and Research Center
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Mid Hudson Medical Research, PLLC
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Nathan S. Kline Institute for Psychiatric Research
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Facility Name
Five Towns Neurology PC/Village Site #764
City
Woodmere
State/Province
New York
ZIP/Postal Code
11598
Country
United States
Facility Name
The Neurological Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
New Hope Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Insight Clinical Trials LLC
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Valley Medical Research Site#788
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
OSUMC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
NorthStar Medical Research
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Onyx Clinical Research, LLC
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44505
Country
United States
Facility Name
Newton Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Orenda Research & Consulting LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73170
Country
United States
Facility Name
Keystone Clinical Studies, LLC
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
Facility Name
Trinity Universal Research Associates Site #821
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Texas Neurology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Bio Pharma Informatic LLC Site#822
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Bio Pharma Informatic Inc Site #769
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Katy Neurology
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Northpointe Psychiatry
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
Facility Name
Wellness Clinical Research
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
PRX Research Site#825
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Wasatch Clinical Research, LLC Site #771
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Core Clinical Research # 772
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
IPC Research
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Australian Alzheimer's Research Foundation
City
Nedlands
Country
Australia
Facility Name
Neuro Trials Victoria Pty Ltd
City
Noble Park
Country
Australia
Facility Name
The Alfred Hospital
City
Parkville
Country
Australia
Facility Name
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski
City
Pleven
Country
Bulgaria
Facility Name
Medical Center Hipokrat-N EOOD
City
Plovdiv
Country
Bulgaria
Facility Name
Center for Mental Health - Ruse
City
Ruse
Country
Bulgaria
Facility Name
Mental Health Centre Prof.Nikola Shipkovenski #713
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
DCC "Sv. Vrach and Sv. Sv. Kuzma and Damian" OOD
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
First Multiprofile Hospital for Active Treatment Sofia
City
Sofia
Country
Bulgaria
Facility Name
Medical Center Stimul
City
Sofia
Country
Bulgaria
Facility Name
Medical Center Sveti Naum
City
Sofia
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Alexandrovska
City
Sofia
Country
Bulgaria
Facility Name
Diagnostic-consultative center Mladost-М Varna OOD #711
City
Varna
ZIP/Postal Code
3020
Country
Bulgaria
Facility Name
Medica Plus Medical Center
City
Veliko Tarnovo
Country
Bulgaria
Facility Name
Mental Health Center Site #712
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
MUDr. Marta Holanová Site# 733
City
Brno
ZIP/Postal Code
61500
Country
Czechia
Facility Name
Fakultni Nemocnice u sv. Anny v Brne #722
City
Brno
Country
Czechia
Facility Name
Clinline Services s.r.0 Psychiatricka ambulance
City
Hostivice
Country
Czechia
Facility Name
Fakultní Nemocnice Hradec Králové #724
City
Hradec Kralové
Country
Czechia
Facility Name
NeuropsychiatrieHK #729
City
Hradec Králové
Country
Czechia
Facility Name
Brain-Soultherapy #728
City
Kladno
Country
Czechia
Facility Name
Supervize #723
City
Kutná Hora
Country
Czechia
Facility Name
A-Shine s.r.o.
City
Plzen
Country
Czechia
Facility Name
Ad71 #727
City
Praha
Country
Czechia
Facility Name
Clintrial #720
City
Praha
Country
Czechia
Facility Name
INEP Medical s.r.o. Institut Neuropsychiatricke Pece
City
Praha
Country
Czechia
Facility Name
Neurologicka Ambulance - Forbeli #721
City
Praha
Country
Czechia
Facility Name
Neuropsychiatrie #726
City
Praha
Country
Czechia
Facility Name
Vestra Clinics #725
City
Rychnov nad Kněžnou
Country
Czechia
Facility Name
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
City
Caen cedex 9
Country
France
Facility Name
Centre Hospitalier de Calais
City
Calais
Country
France
Facility Name
Centre Hospitalier Universitaire Dijon Bourgogn
City
Dijon Cedex
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes - Hôpital Nord Laennec
City
Nantes Cedex
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers
Country
France
Facility Name
Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord
City
Saint-Etienne
Country
France
Facility Name
Centre Hospitalier Universitaire Toulouse - Casselardit Ancely
City
Toulouse
Country
France
Facility Name
Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
City
Vandoeuvre les Nancy
Country
France
Facility Name
Dr. Kenessey Albert Kórház-Rendelőintézet
City
Balassagyarmat
Country
Hungary
Facility Name
Semmelweis Egyetem Site#595
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
Country
Hungary
Facility Name
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
City
Debrecen
Country
Hungary
Facility Name
Valeomed Egeszsegugyi es Szolgaltato Kft
City
Esztergom
Country
Hungary
Facility Name
Petz Aladár Egyetemi Oktató Kórház Site# 594
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Dr. Mathe es Tarsa Beteti Tarsasa Site #593
City
Kalocsa
ZIP/Postal Code
6300
Country
Hungary
Facility Name
CRU Hungary Egészségügyi és Szolgáltató Korlátolt Felelősségű Társaság
City
Miskolc
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyiregyhaza
Country
Hungary
Facility Name
PsychoTech
City
Pecs
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
Country
Hungary
Facility Name
Fejér Megyei Szent György Egyetemi Oktató Kórház
City
Székesfehérvár
Country
Hungary
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
Centro San Giovanni di Dio - Fatebenefratelli
City
Brescia
Country
Italy
Facility Name
Università degli studi G.D'Annunzio Chieti Pescara
City
Chieti
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Careggi
City
Firenze
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo di Monza
City
Monza
Country
Italy
Facility Name
Azienda Sanitaria Locale di Biella - Nuovo Ospedale degli Infermi
City
Ponderano
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea
City
Roma
Country
Italy
Facility Name
Fondazione Policlinico Tor Vergata
City
Roma
Country
Italy
Facility Name
Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico
City
Roma
Country
Italy
Facility Name
Śródmieście Przychodnia - Bydgoszcz
City
Bydgoszcz
Country
Poland
Facility Name
Centrum Medyczne Sensemed
City
Chorzów
Country
Poland
Facility Name
Care Clinic
City
Katowice
Country
Poland
Facility Name
Wielospecjalistyczna Poradnia Lekarska Synapsis #741
City
Katowice
Country
Poland
Facility Name
Krakowska Akademia Neurologii
City
Kraków
Country
Poland
Facility Name
Pratia MCM Kraków
City
Kraków
Country
Poland
Facility Name
Medycyna Milorzab #743
City
Lodz
Country
Poland
Facility Name
Twoja Przychodnia - Centrum Medyczne Nowa Sol #757
City
Nowa Sól
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Neurologiczny Niepubliczny Zakład Opieki Zdrowotnej
City
Plewiska
Country
Poland
Facility Name
Centrum Medyczne HCP
City
Poznań
Country
Poland
Facility Name
Solumed Centrum Medyczne #753
City
Poznań
Country
Poland
Facility Name
RCMed Oddział Sochaczew #510
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
Amonaria Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda
City
Suchy Las
ZIP/Postal Code
62-002
Country
Poland
Facility Name
Centrum Medyczne Euromedis
City
Szczecin
Country
Poland
Facility Name
Przychodnia Specjalistyczna Prosen Site#758
City
Warszawa
ZIP/Postal Code
01-231
Country
Poland
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
Country
Poland
Facility Name
Centrum Medyczne Pratia Warszawa
City
Warszawa
Country
Poland
Facility Name
ClinHouse Centrum Medyczne #755
City
Zabrze
ZIP/Postal Code
41-807
Country
Poland
Facility Name
Ośrodek Alzheimerowski #756
City
Ścinawa
ZIP/Postal Code
59-330
Country
Poland
Facility Name
ACF Neurological Services
City
Cape Town
Country
South Africa
Facility Name
Cape Trial Centre
City
Cape Town
Country
South Africa
Facility Name
Flexivest Fourteen Research Centre
City
Cape Town
Country
South Africa
Facility Name
Apollo Clinical Research
City
Johannesburg
Country
South Africa
Facility Name
Medical and Dental Centre
City
Rosebank
Country
South Africa
Facility Name
Dr. Chisto Carel Coetzee
City
Umhlanga
Country
South Africa
Facility Name
Accellacare Alcobendas #659
City
Alcobendas
State/Province
Aocobendas
ZIP/Postal Code
28100
Country
Spain
Facility Name
Fundació ACE
City
Barcelona
Country
Spain
Facility Name
Fundació Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
Country
Spain
Facility Name
Hospital General Universitario de Elche
City
Elche
Country
Spain
Facility Name
Hospital Universitari de Santa Maria
City
Lleida
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario y Politécnico de La Fe
City
Valencia
Country
Spain
Facility Name
Complejo Asistencial de Zamora Hospital Virgen de la Concha
City
Zamora
Country
Spain
Facility Name
Hospital Viamed Montecanal
City
Zaragoza
Country
Spain
Facility Name
MAC Clinical Research - Barnsley Site #671
City
Barnsley
Country
United Kingdom
Facility Name
Research Institute for the Care of Older People
City
Bath
Country
United Kingdom
Facility Name
Belfast Health and Social Care Trust
City
Belfast
Country
United Kingdom
Facility Name
MAC Clinical Research - Blackpool
City
Blackpool
Country
United Kingdom
Facility Name
MAC Clinical Research - Cannock
City
Cannock
Country
United Kingdom
Facility Name
MAC Clinical Research - Leeds
City
Leeds
Country
United Kingdom
Facility Name
Re:Cognition Health - London
City
London
Country
United Kingdom
Facility Name
South London and Maudsley NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
MAC Clinical Research - Manchester
City
Manchester
Country
United Kingdom
Facility Name
Northamptonshire Healthcare NHS Foundation Trust
City
Northampton
Country
United Kingdom
Facility Name
MAC Clinical Research - Liverpool
City
Prescot
Country
United Kingdom
Facility Name
Southern Health NHS Foundation Trust
City
Southampton
Country
United Kingdom
Facility Name
Avon and Wiltshire Mental Health Partnership NHS Trust
City
Swindon
Country
United Kingdom
Facility Name
North West Boroughs Healthcare NHS Foundation Trust
City
Warrington
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
IPD Sharing Time Frame
Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD Sharing Access Criteria
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
IPD Sharing URL
https://clinical-trials.otsuka.com

Learn more about this trial

Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

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