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

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

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.

Study Overview

• Status: Completed
• Conditions: Agitation in Patients With Dementia of the Alzheimer's Type
• Intervention / Treatment: Drug: Placebo; Drug: AVP-786

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.

• Study Type: Interventional
• Enrollment (Actual): 601
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Nedlands, Australia
    • Australian Alzheimer's Research Foundation
  • Noble Park, Australia
    • Neuro Trials Victoria Pty Ltd
  • Parkville, Australia
    • The Alfred Hospital
• Bulgaria
  • Pleven, Bulgaria
    • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski
  • Plovdiv, Bulgaria
    • Medical Center Hipokrat-N EOOD
  • Ruse, Bulgaria
    • Center for Mental Health - Ruse
  • Sofia, Bulgaria, 1000
    • Mental Health Centre Prof.Nikola Shipkovenski #713
  • Sofia, Bulgaria
    • First Multiprofile Hospital for Active Treatment Sofia
  • Sofia, Bulgaria
    • Medical Center Stimul
  • Sofia, Bulgaria
    • University Multiprofile Hospital for Active Treatment Alexandrovska
  • Sofia, Bulgaria, 1408
    • DCC "Sv. Vrach and Sv. Sv. Kuzma and Damian" OOD #710
  • Sofia, Bulgaria
    • Medical Center Sveti Naum #707
  • Varna, Bulgaria, 3020
    • Diagnostic-consultative center Mladost-М Varna OOD #711
  • Veliko Tarnovo, Bulgaria
    • Medica Plus Medical Center #705
  • Vratsa, Bulgaria, 3000
    • Mental Health Center Site #712
• Czechia
  • Brno, Czechia, 61500
    • MUDr. Marta Holanová Site# 733
  • Brno, Czechia
    • Fakultni Nemocnice u sv. Anny v Brne #722
  • Hostivice, Czechia
    • Clinline Services s.r.0 Psychiatricka ambulance #732
  • Hradec Kralové, Czechia
    • Fakultní Nemocnice Hradec Králové #724
  • Hradec Králové, Czechia
    • NeuropsychiatrieHK #729
  • Kladno, Czechia
    • Brain-Soultherapy #728
  • Kutná Hora, Czechia
    • Supervize #723
  • Plzen, Czechia
    • A-SHINE s.r.o.
  • Praha, Czechia
    • Ad71 #727
  • Praha, Czechia
    • Clintrial #720
  • Praha, Czechia
    • Neurologicka Ambulance - Forbeli #721
  • Praha, Czechia
    • Neuropsychiatrie #726
  • Praha, Czechia
    • INEP Medical s.r.o. Institut Neuropsychiatricke Pece #730
  • Rychnov nad Kněžnou, Czechia
    • Vestra Clinics #725
• France
  • Caen cedex 9, France
    • Centre Hospitalier Universitaire de Caen - Hopital Cote de Nacre
  • Calais, France
    • Centre hospitalier de Calais
  • Dijon Cedex, France
    • Centre Hospitalier Universitaire Dijon Bourgogn #536
  • Nantes Cedex, France, 44093
    • Centre Hospitalier Universitaire de Nantes - Hôpital Nord Laennec #537
  • Poitiers, France
    • Centre Hospitalier Universitaire de Poitiers
  • Saint-Etienne, France
    • Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord #535
  • Toulouse, France
    • Centre Hospitalier Universitaire Toulouse - Casselardit Ancely #533
  • Vandoeuvre les Nancy, France
    • Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
• Hungary
  • Balassagyarmat, Hungary
    • Dr. Kenessey Albert Korhaz-Rendelointezet
  • Budapest, Hungary
    • Semmelweis Egyetem
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem Site #595
  • Budapest, Hungary
    • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak #586
  • Debrecen, Hungary
    • Debreceni Egyetem Kenézy Gyula Egyetemi Kórház
  • Esztergom, Hungary
    • Valeomed Egeszsegugyi es Szolgaltato Kft
  • Győr, Hungary, 9024
    • Petz Aladár Egyetemi Oktató Kórház Site# 594
  • Kalocsa, Hungary, 6300
    • Dr. Mathe es Tarsa Beteti Tarsasa Site #593
  • Miskolc, Hungary
    • CRU Hungary Egészségügyi és Szolgáltató Korlátolt Felelősségű Társaság
  • Nyiregyhaza, Hungary
    • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
  • Pecs, Hungary
    • PsychoTech #580
  • Szeged, Hungary
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Székesfehérvár, Hungary
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
• Italy
  • Brescia, Italy
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  • Brescia, Italy
    • Centro San Giovanni di Dio - Fatebenefratelli
  • Chieti, Italy
    • Università degli studi G.D'Annunzio Chieti Pescara
  • Firenze, Italy
    • Azienda Ospedaliero - Universitaria Careggi #610
  • Milano, Italy
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Monza, Italy
    • Azienda Ospedaliera San Gerardo di Monza
  • Ponderano, Italy
    • Azienda Sanitaria Locale di Biella - Nuovo Ospedale degli Infermi
  • Roma, Italy
    • Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico
  • Roma, Italy
    • Azienda Ospedaliera Sant'Andrea #606
  • Roma, Italy
    • Fondazione Policlinico Tor Vergata #609
• Poland
  • Bydgoszcz, Poland
    • Śródmieście Przychodnia - Bydgoszcz
  • Chorzów, Poland
    • Centrum Medyczne Sensemed
  • Katowice, Poland
    • Wielospecjalistyczna Poradnia Lekarska Synapsis #741
  • Katowice, Poland
    • Care Clinic #750
  • Kraków, Poland
    • Krakowska Akademia Neurologii #740
  • Kraków, Poland
    • Pratia MCM Kraków #747
  • Lodz, Poland
    • Medycyna Milorzab #743
  • Nowa Sól, Poland, 67-100
    • Twoja Przychodnia - Centrum Medyczne Nowa Sol #757
  • Plewiska, Poland
    • Neurologiczny Niepubliczny Zakład Opieki Zdrowotnej
  • Poznań, Poland
    • Centrum Medyczne HCP
  • Poznań, Poland
    • Solumed Centrum Medyczne #753
  • Sochaczew, Poland, 96-500
    • RCMed Oddział Sochaczew #510
  • Suchy Las, Poland, 62-002
    • Amonaria Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda #508
  • Szczecin, Poland
    • Centrum Medyczne Euromedis
  • Warszawa, Poland
    • Centrum Medyczne NeuroProtect
  • Warszawa, Poland, 01-231
    • Przychodnia Specjalistyczna Prosen Site#758
  • Warszawa, Poland
    • Centrum Medyczne Pratia Warszawa
  • Zabrze, Poland, 41-807
    • ClinHouse Centrum Medyczne #755
  • Ścinawa, Poland, 59-330
    • Ośrodek Alzheimerowski #756
• South Africa
  • Cape Town, South Africa
    • ACF Neurological Services
  • Cape Town, South Africa
    • Cape Trial Centre #621
  • Cape Town, South Africa
    • Flexivest Fourteen Research Centre #620
  • Johannesburg, South Africa
    • Apollo Clinical Research #623
  • Rosebank, South Africa
    • Medical and Dental Centre #625
  • Umhlanga, South Africa
    • Dr. Chisto Carel Coetzee
• Spain
  • Barcelona, Spain
    • Hospital Clinic de Barcelona
  • Barcelona, Spain
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain
    • Fundació Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain
    • Fundacio ACE
  • Córdoba, Spain
    • Hospital Universitario Reina Sofia #647
  • Elche, Spain
    • Hospital General Universitario de Elche
  • Lleida, Spain
    • Hospital Universitari de Santa Maria
  • Madrid, Spain
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Majadahonda, Spain, 28222
    • Hospital Universitario Puerta de Hierro - Majadahonda #658
  • Pamplona, Spain
    • Clinica Universidad de Navarra
  • Salamanca, Spain
    • Hospital Universitario de Salamanca #656
  • Santander, Spain
    • Hospital Universitario Marqués de Valdecilla
  • Sevilla, Spain
    • Hospital Universitario Virgen Macarena #649
  • Valencia, Spain
    • Hospital Universitario y Politecnico de la Fe
  • Zamora, Spain
    • Complejo Asistencial de Zamora Hospital Virgen de la Concha #652
  • Zaragoza, Spain
    • Hospital Viamed Montecanal #643
  • Aocobendas
    • Alcobendas, Aocobendas, Spain, 28100
      • Accellacare Alcobendas #659
• United Kingdom
  • Barnsley, United Kingdom
    • MAC Clinical Research - Barnsley Site #671
  • Bath, United Kingdom
    • Research Institute for the Care of Older People
  • Belfast, United Kingdom
    • Belfast Health and Social Care Trust
  • Blackpool, United Kingdom
    • MAC Clinical Research - Blackpool
  • Cannock, United Kingdom
    • MAC Clinical Research - Cannock #672
  • Leeds, United Kingdom
    • MAC Clinical Research - Leeds
  • London, United Kingdom
    • South London and Maudsley NHS Foundation Trust
  • London, United Kingdom
    • Re:Cognition Health - London
  • Manchester, United Kingdom
    • MAC Clinical Research - Manchester
  • Northampton, United Kingdom
    • Northamptonshire Healthcare NHS Foundation Trust #682
  • Prescot, United Kingdom
    • MAC Clinical Research - Liverpool
  • Southampton, United Kingdom
    • Southern Health NHS Foundation Trust #679
  • Swindon, United Kingdom
    • Avon and Wiltshire Mental Health Partnership NHS Trust
  • Warrington, United Kingdom
    • North West Boroughs Healthcare NHS Foundation Trust #685
• United States
  • Arizona
    • Chandler, Arizona, United States, 85286
      • MD First Research #767
    • Gilbert, Arizona, United States, 85296
      • Liv Generations of Agritopia / CCT #573
    • Phoenix, Arizona, United States, 85048
      • Liv Generations of Ahwatukee / CCT #784
    • Scottsdale, Arizona, United States, 85254
      • Perseverance Research Center
    • Tempe, Arizona, United States, 85283
      • Medical Advancement Center of Arizona #820
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Clinical Trials Inc.
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center, Inc #835
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research, Inc #763
    • La Mesa, California, United States, 91942
      • Paradigm Clinical Research Centers, Inc.
    • Lafayette, California, United States, 94549
      • Sunwise Clinical Research #831
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute, Inc. #826
    • Long Beach, California, United States, 90805
      • Rohun Medical Corporation Site #770
    • Long Beach, California, United States, 90807
      • Alliance for Wellness, Inc dba Alliance for Research #789
    • Pasadena, California, United States, 91105
      • Havana Research Institute
  • Florida
    • Altamonte Springs, Florida, United States, 32714
      • Neurology of Central Florida Rsch Ctr # 803
    • Aventura, Florida, United States, 33180
      • Negron Research Services / Humanity Clinical Research #766
    • Boca Raton, Florida, United States, 33487
      • SFM Clinical Research, LLC #563
    • Boynton Beach, Florida, United States, 33436
      • Helix Biomedics LLC
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center #834
    • Brandon, Florida, United States, 33511
      • Clinical Research of Brandon #838
    • Brooksville, Florida, United States, 34613
      • ASCLEPES Research Center #806
    • Cutler Bay, Florida, United States, 33157
      • Beautiful Minds Clinical Research Center #808
    • Doral, Florida, United States, 33178
      • Science Connections, LLC #814
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center # 801
    • Hialeah, Florida, United States, 33012
      • ConSalud Medical Research #773
    • Hollywood, Florida, United States, 33020
      • New Med Research Inc #812
    • Jupiter, Florida, United States, 33458
      • Alphab Global Research #793
    • Lake Worth, Florida, United States, 33449
      • Alzheimer's Research and Treatment Center
    • Lakeland, Florida, United States, 33805
      • Meridien Research - Lakeland Site Site #558
    • Lauderdale Lakes, Florida, United States, 33313
      • Zynak Clinical Services
    • Lauderhill, Florida, United States, 33319
      • Adaptive Clinical Research, Inc. Site# 815
    • Lauderhill, Florida, United States, 33319
      • Innovative Clinical Research, Inc Site #819
    • Miami, Florida, United States, 33175
      • Pharmax Research of South Florida
    • Miami, Florida, United States, 33032
      • Homestead Associates in Research #797
    • Miami, Florida, United States, 33125
      • Central Miami Medical Institute # 798
    • Miami, Florida, United States, 33125
      • Project4Research #774
    • Miami, Florida, United States, 33126
      • City Medical Group RC
    • Miami, Florida, United States, 33126
      • First Class Medical Services #807
    • Miami, Florida, United States, 33165
      • New Horizon Research Center Site #795
    • Miami, Florida, United States, 33165
      • Reliant Medical Research, LLC #811
    • Miami, Florida, United States, 33172
      • Clinical Research Associates of South Florida
    • Miami, Florida, United States, 33175
      • P&S Research, LLC #805
    • Miami, Florida, United States, 33186
      • Research Institute of West Kendall
    • Miami, Florida, United States, 33122
      • Premier Clinical Research Institute, Inc. #817
    • Miami, Florida, United States, 33126
      • Finlay Medical Research Corp #552
    • Miami, Florida, United States, 33137
      • Miami Jewish Health Systems, Inc. #786
    • Miami Lakes, Florida, United States, 33014
      • Crystal Biomedical Research, LLC
    • Miami Lakes, Florida, United States, 33016
      • Agility Medical Research, Inc Site #816
    • New Port Richey, Florida, United States, 34655
      • Bayside Clinical Research
    • Orlando, Florida, United States, 32807
      • Combined Research Orlando #799
    • Palmetto, Florida, United States, 33157
      • Innovation Medical Research Center #802
    • Pompano Beach, Florida, United States, 33064
      • Quantum Laboratories Site #768
    • Port Charlotte, Florida, United States, 33952
      • Neurostudies Inc. Site# 796
    • Tampa, Florida, United States, 33617
      • Academic Alliance in Dermatology
    • Tampa, Florida, United States, 33615
      • VICIS Clinical Research Inc. #777
    • Tampa, Florida, United States, 33634
      • JSV Clinical Research Study, Inc. #829
  • Georgia
    • Decatur, Georgia, United States, 30033
      • NeuroStudies. Net, LLC
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Pacific Neuroscience #833
  • Louisiana
    • Covington, Louisiana, United States, 70443
      • DelRicht Research #776
  • Massachusetts
    • Braintree, Massachusetts, United States, 02184
      • Alzheimer Disease Center #804
  • Michigan
    • Bloomfield, Michigan, United States, 48302
      • Neurobehavioral Medicine Group #828
    • Caro, Michigan, United States, 48723
      • Onyx Clinical Research, LLC
    • Troy, Michigan, United States, 48085
      • Oakland Medical Research #762
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers Site #765
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Galen Research Site #550
    • O'Fallon, Missouri, United States, 63368
      • Psychiatric Care and Research Center #827
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • New York
    • New Windsor, New York, United States, 12553
      • Mid Hudson Medical Research, PLLC #836
    • Orangeburg, New York, United States, 10962
      • Nathan S. Kline Institute for Psychiatric Research
    • Woodmere, New York, United States, 11598
      • Five Towns Neurology PC/Village Site #764
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • New Hope Clinical Research
    • Charlotte, North Carolina, United States, 28204
      • The Neurological Institute #843
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Insight Clinical Trials LLC #570
    • Centerville, Ohio, United States, 45459
      • Valley Medical Research Site#788
    • Columbus, Ohio, United States, 43221
      • Osumc #837
    • Middleburg Heights, Ohio, United States, 44130
      • NorthStar Medical Research #778
    • Youngstown, Ohio, United States, 44505
      • Onyx Clinical Research, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Newton Clinical Research
    • Oklahoma City, Oklahoma, United States, 73170
      • Orenda Research & Consulting LLC #840
  • Pennsylvania
    • Norristown, Pennsylvania, United States, 19403
      • Keystone Clinical Studies, LLC
  • Texas
    • Carrollton, Texas, United States, 75007
      • Trinity Universal Research Associates Site #821
    • Dallas, Texas, United States, 75206
      • Texas Neurology #832
    • DeSoto, Texas, United States, 75115
      • InSite Clinical Research
    • Houston, Texas, United States, 77084
      • Bio Pharma Informatic Inc Site #769
    • Houston, Texas, United States, 77043
      • Bio Pharma Informatic LLC Site #822
    • Katy, Texas, United States, 77450
      • Katy Neurology #823
    • Lewisville, Texas, United States, 75057
      • Northpointe Psychiatry #761
    • McKinney, Texas, United States, 75071
      • Wellness Clinical Research #824
    • Mesquite, Texas, United States, 75149
      • PRX Research Site #825
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research, LLC Site #771
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Everett, Washington, United States, 98201
      • Core Clinical Research # 772
  • Wisconsin
    • Waukesha, Wisconsin, United States, 53188
      • IPC Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.	Drug: Placebo; oral capsules
Experimental: AVP-786; Dose 1; Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.	Drug: AVP-786; oral capsules
Experimental: AVP-786; Dose 2; Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.	Drug: AVP-786; oral capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score	Baseline; Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2017
• Primary Completion (Actual): November 17, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Agitation; Dementia of the Alzheimer's type; AVP-786; Deudextromethorphan hydrobromide; Quinidine sulfate
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurobehavioral Manifestations; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Dyskinesias; Psychomotor Disorders; Alzheimer Disease; Dementia; Psychomotor Agitation
• Other Study ID Numbers: 17-AVP-786-305; 2017-001339-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No