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NCT02446132TerminatedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 15 Oct 2025

Reason given: The AVP-786 program was discontinued, the recruitment was stopped and all participants are no longer being examined or receiving intervention.

Brief summary (registry, in English)

This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.

Status (registry)
Terminated
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1197 (actual)
First submitted
11 May 2015
Start date
13 Nov 2015
Primary completion date
6 Sept 2024
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
NCT number
NCT02446132
EudraCT number
2017-002455-29

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline

Other illness

  • 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)

Other

  • Participants determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator

Who the study is looking for

  • 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

Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (227)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Center for Mental Health - RuseRousseBulgariaUnknown status
University Multiprofile Hospital for Active Treatment Alexandrovska Site #704SofiaBulgariaUnknown status
Mental Health Centre Prof. Nikola Shipkovenski Site #713SofiaBulgariaUnknown status
Medical Center Sveti Naum Site #707SofiaBulgariaUnknown status
Vrach and Sv. Sv. Kuzma and Damian Site #710SofiaBulgariaUnknown status
Medical Center Mladost-MVarnaBulgariaUnknown status
Medica Plus Medical CenterVeliko TarnovoBulgariaUnknown status
Dr. Alexander McIntyre Inc.PentictonCanadaUnknown status
Fakultni Nemocnice u sv. Anny v Brne Site #722BrnoCzechiaUnknown status
Fakultní Nemocnice Hradec Králové Site #724Hradec KralovéCzechiaUnknown status
-Hradec KralovéCzechiaUnknown status
Brain-SoultherapyKladnoCzechiaUnknown status
Námestí národního odboje 692 Site #723Kutná HoraCzechiaUnknown status
-PilsenCzechiaUnknown status
ClintrialPragueCzechiaUnknown status
AD71PragueCzechiaUnknown status
-PragueCzechiaUnknown status
Neurologická Ambulance - ForbeliPragueCzechiaUnknown status
Vestra ClinicsRychnov nad KněžnouCzechiaUnknown status
Accellacare AlcobendasAlcobendasSpainUnknown status
Fundació ACEBarcelonaSpainUnknown status
Hospital Clinic de BarcelonaBarcelonaSpainUnknown status
Hospital General Universitario de ElcheElcheSpainUnknown status
Hospital Universitario De SalamancaSalamancaSpainUnknown status
Hospital Universitario Virgen Macarena Site #649SevilleSpainUnknown status
Complejo Asistencial de Zamora Hospital Virgen de la ConchaZamoraSpainUnknown status
Hospital Viamed Montecanal Site #643ZaragozaSpainUnknown status
Centre Hospitalier Universitaire Dijon Bourgogn Site #536DijonFranceUnknown status
Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord Site #535Saint-EtienneFranceUnknown status
Centre Hospitalier Universitaire Toulouse - Casselardit Ancely Site #533ToulouseFranceUnknown status
Dr. Kenessey Albert Kórház-RendelőintézetBalassagyarmatHungaryUnknown status
Semmelweis EgyetemBudapestHungaryUnknown status
Pszichiatriai es Pszichiatriai Rehabilitacios Osztaly Site #586BudapestHungaryUnknown status
Debreceni Egyetem Kenezy Gyula Egyetemi KorhazDebrecenHungaryUnknown status
Dr. Mathe es Tarsa Beteti Tarsasag Site #593KalocsaHungaryUnknown status
-PécsHungaryUnknown status
Azienda Ospedaliera Sant'Andrea Site #606RomaItalyUnknown status
Fondazione Policlinico Tor Vergata Site #609RomaItalyUnknown status
Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere ScientificoRomaItalyUnknown status
Ksiedza Hugona Kollataja 9BydgoszczPolandUnknown status
Wielospecjalistyczna Poradnia Lekarska Synapsis Site #741KatowicePolandUnknown status
Care Clinic Clinical Research Site #750KatowicePolandUnknown status
-KrakowPolandUnknown status
Malopolskie Centrum Medyczne Site #747KrakowPolandUnknown status
-LodzPolandUnknown status
Twoja Przychodnia - Centrum Medyczne Nowa Sol Site #757Nowa SólPolandUnknown status
Solumed Centrum Medyczne Site #753PoznanPolandUnknown status
-SochaczewPolandUnknown status
Centrum Medyczne EuromedisSzczecinPolandUnknown status
Centrum Medyczne NeuroProtect Site #742WarsawPolandUnknown status
ClinHouse Centrum MedyczneZabrzePolandUnknown status
Neurology and Neuroscience Associates, Inc.AkronUnited StatesUnknown status
Neurology of Central Florida Rsch Ctr Site #803Altamonte SpringsUnited StatesUnknown status
Dent Neurologic InstituteAmherstUnited StatesUnknown status
Advanced Research Center, Inc. Site #835AnaheimUnited StatesUnknown status
NeuroTrials Research IncAtlantaUnited StatesUnknown status
JEM Research InstituteAtlantisUnited StatesUnknown status
Negron Research Services / Humanity Clinical Research Site# 766AventuraUnited StatesUnknown status
Insight Clinical Trials, LLC Site #570BeachwoodUnited StatesUnknown status
Heritage Valley Medical Group, Inc.BeaverUnited StatesUnknown status
Northwest Clinical Research CenterBellevueUnited StatesUnknown status
Clinical Neuroscience Research Associates, Inc. dba The Memory ClinicBenningtonUnited StatesUnknown status
SFM Clinical Research, LLC Site #563Boca RatonUnited StatesUnknown status
Bradenton Research Center Site #834BradentonUnited StatesUnknown status
Alzheimer Disease Center Site #804BraintreeUnited StatesUnknown status
Clinical Research of BrandonBrandonUnited StatesUnknown status
Clinical Research Of Brandon, LLC Site #838BrandonUnited StatesUnknown status
Integrative Clinical Trials LLC #1BrooklynUnited StatesUnknown status
Integrative Clinical Trials LLC #2BrooklynUnited StatesUnknown status
Meridien ResearchBrooksvilleUnited StatesUnknown status
Onyx Clinical Research, LLCCaroUnited StatesUnknown status
Valley Medical Research Site#788CentervilleUnited StatesUnknown status
Valley Medical ResearchCentervilleUnited StatesUnknown status
MD First Research, LLC Site #767ChandlerUnited StatesUnknown status
Herbert Harris, Md, Phd, PaChapel HillUnited StatesUnknown status
Roper St. Francis HealthcareCharlestonUnited StatesUnknown status
RH Johnson VA Medical CenterCharlestonUnited StatesUnknown status
ANI Neurology PLLC dba Alzheimer's Memory CenterCharlotteUnited StatesUnknown status
Galen ResearchChesterfieldUnited StatesUnknown status
University of CincinnatiCincinnatiUnited StatesUnknown status
Ericksen Research and DevelopmentClintonUnited StatesUnknown status
Medical Research & Health Education Foundation, Inc.ColumbusUnited StatesUnknown status
Columbus Research & Wellness Institute, INCColumbusUnited StatesUnknown status
The Ohio State UniversityColumbusUnited StatesUnknown status
ATP Clinical Research, Inc. Site #763Costa MesaUnited StatesUnknown status
Millennium Psychiatric Associates, LLCCreve CoeurUnited StatesUnknown status
University Texas Southwestern Medical CenterDallasUnited StatesUnknown status
Texas Neurology, P.A.DallasUnited StatesUnknown status
Neurology Consultants of Dallas, PADallasUnited StatesUnknown status
NeuroStudies.net, LLCDecaturUnited StatesUnknown status
Quantum Laboratories, Inc.Deerfield BeachUnited StatesUnknown status
Lytle and Weiss, PLLC dba Clinical Trials of the RockiesDenverUnited StatesUnknown status
-DeSotoUnited StatesUnknown status
Science Connections, LLC Site #814DoralUnited StatesUnknown status
Moonshine Research Center, Inc.DoralUnited StatesUnknown status
Duke University Medical CenterDurhamUnited StatesUnknown status
Michigan State University Department of NeurologyEast LansingUnited StatesUnknown status
The Samuel & Alexia Bratton Memory ClinicEastonUnited StatesUnknown status
Rhode Island Mood & Memory Research InstituteEast ProvidenceUnited StatesUnknown status
-EverettUnited StatesUnknown status
Health Initiatives ResearchFayettevilleUnited StatesUnknown status
Behavioral Research Specialists, LLCGlendaleUnited StatesUnknown status
Finlay Medical Research CorpGreenacres CityUnited StatesUnknown status
Mir NeurologyHagerstownUnited StatesUnknown status
New Life Medical Research Center, IncHialeahUnited StatesUnknown status
The Research Center, IncHialeahUnited StatesUnknown status
Indago Research & Health Center, IncHialeahUnited StatesUnknown status
Reliable Clinical Research LLCHialeahUnited StatesUnknown status
Berma Research GroupHialeahUnited StatesUnknown status
Galiz ResearchHialeahUnited StatesUnknown status
Direct Helpers Research Center # 801HialeahUnited StatesUnknown status
Maxblue InstituteHialeahUnited StatesUnknown status
Research in Miami IncHialeahUnited StatesUnknown status
Baylor College of MedicineHoustonUnited StatesUnknown status
Houston Methodist Neurological InstituteHoustonUnited StatesUnknown status
Indiana University School of MedicineIndianapolisUnited StatesUnknown status
Josephson Wallack Munshower Neurology, PCIndianapolisUnited StatesUnknown status
Irvine Center for Clinical ResearchIrvineUnited StatesUnknown status
Clinical NeuroScience Solutions IncJacksonvilleUnited StatesUnknown status
Alphab Global Research #793JupiterUnited StatesUnknown status
SIH Research, LLCKissimmeeUnited StatesUnknown status
-LakelandUnited StatesUnknown status
-LakewoodUnited StatesUnknown status
Cleveland Clinic Lou Ruvo Center for Brain Health at Lakewood HospitalLakewoodUnited StatesUnknown status
Alzheimer's Research and Treatment Center #2Lake WorthUnited StatesUnknown status
Alzheimer's Research and Treatment Center #3Lake WorthUnited StatesUnknown status
Alzheimer's Research and Treatment Center #1Lake WorthUnited StatesUnknown status
Innovative Clinical Research, Inc Site #819LauderhillUnited StatesUnknown status
MidAmerica Neuroscience Research FoundationLenexaUnited StatesUnknown status
Torrance Clinical Research Institute, Inc. Site #826LomitaUnited StatesUnknown status
Alliance for Wellness, Inc dba Alliance for Research Site #789Long BeachUnited StatesUnknown status
Collaborative NeuroScience Network LLCLong BeachUnited StatesUnknown status
-MesquiteUnited StatesUnknown status
Dade Research Center LlcMiamiUnited StatesUnknown status
Kendall Research InstituteMiamiUnited StatesUnknown status
First Class Medical Services Site #807MiamiUnited StatesUnknown status
Pharmax Research of South FloridaMiamiUnited StatesUnknown status
Hope Research Network LLC Site #773MiamiUnited StatesUnknown status
Clinical Research Associates of South Florida #2MiamiUnited StatesUnknown status
Project 4 Research #1MiamiUnited StatesUnknown status
Miami Jewish Health Systems, Inc.MiamiUnited StatesUnknown status
Future Care Solution LLCMiamiUnited StatesUnknown status
United Health Research Corp. #1MiamiUnited StatesUnknown status
Advanced Medical Center GroupMiamiUnited StatesUnknown status
Advance Medical Research Center #2MiamiUnited StatesUnknown status
Clinical Research Associates of South Florida #1MiamiUnited StatesUnknown status
Global Medical Institutes, LLCMiamiUnited StatesUnknown status
United Health Research Corp. #2MiamiUnited StatesUnknown status
Finlay Medical Research Corp Site #552MiamiUnited StatesUnknown status
Project 4 Research #2MiamiUnited StatesUnknown status
Advance Medical Research Center #1MiamiUnited StatesUnknown status
-MiamiUnited StatesUnknown status
Coral Research Clinic Corp.MiamiUnited StatesUnknown status
Optimus U CorpMiamiUnited StatesUnknown status
Reliant Medical Research LLC Site #811MiamiUnited StatesUnknown status
Central Miami Medical Institute Site #798MiamiUnited StatesUnknown status
Vitae Researrch Center LLCMiamiUnited StatesUnknown status
Nuovida Research Center CorpMiamiUnited StatesUnknown status
BioMed Research InstituteMiamiUnited StatesUnknown status
Premier Clinical Research Institute, Inc. #1MiamiUnited StatesUnknown status
CCM Clinical Research GroupMiamiUnited StatesUnknown status
University of MiamiMiamiUnited StatesUnknown status
Innova Clinical TrialsMiamiUnited StatesUnknown status
Premier Clinical Research Institute, Inc. #2MiamiUnited StatesUnknown status
P&S RESEARCH, LLC. Site #805MiamiUnited StatesUnknown status
New Med Research, Inc Site #812Miami GardensUnited StatesUnknown status
NorthStar Medical Research Site #778Middleburg HeightsUnited StatesUnknown status
The NeuroCognitive InstituteMount ArlingtonUnited StatesUnknown status
Collier Neurologic Specialists, LLCNaplesUnited StatesUnknown status
Naples Research, IncNaplesUnited StatesUnknown status
Coastal Connecticut Research, LLCNew LondonUnited StatesUnknown status
-New Port RicheyUnited StatesUnknown status
Boston Center for MemoryNewtonUnited StatesUnknown status
Manhattan Behavioral Medicine PLLCNew YorkUnited StatesUnknown status
Eastside Comprehensive Medical Center, LLCNew YorkUnited StatesUnknown status
Columbia University Medical CenterNew YorkUnited StatesUnknown status
Research Center for Clinical Studies, Inc.NorwalkUnited StatesUnknown status
Research Centers of America LLCOakland ParkUnited StatesUnknown status
IPS Research CompanyOklahoma CityUnited StatesUnknown status
Oklahoma Clinical Research CenterOklahoma CityUnited StatesUnknown status
NRC Research InstituteOrangeUnited StatesUnknown status
Nathan S. Kline Institute for Psychiatric Research #571OrangeburgUnited StatesUnknown status
Nathan S. Kline Institute for Psychiatric Research #1OrangeburgUnited StatesUnknown status
-OrlandoUnited StatesUnknown status
Compass Research, LLCOrlandoUnited StatesUnknown status
Neurology Associates of Ormond BeachOrmond BeachUnited StatesUnknown status
Four Rivers Clinical Research IncPaducahUnited StatesUnknown status
Innovation Medical Research CenterPalmetto BayUnited StatesUnknown status
Innovation Medical Research Center Site #802Palmetto BayUnited StatesUnknown status
IMIC, Inc.Palmetto BayUnited StatesUnknown status
California Neurological ServicesPanorama CityUnited StatesUnknown status
Havana Research Institute Site 787PasadenaUnited StatesUnknown status
Havana Research InstitutePasadenaUnited StatesUnknown status
University of West FloridaPensacolaUnited StatesUnknown status
NoesisPharma, LLCPhoenixUnited StatesUnknown status
Neurostudies Inc. Site# 796Port CharlotteUnited StatesUnknown status
Alzheimer's Disease CenterQuincyUnited StatesUnknown status
University of Rochester Medical CenterRochesterUnited StatesUnknown status
Veteran Affairs Medical Center, Salem VirginiaSalemUnited StatesUnknown status
Pharmaceuticals Research Associates, Inc.Salt Lake CityUnited StatesUnknown status
Texas Medical Research Associates, L.L.C.San AntonioUnited StatesUnknown status
Pacific Research Network, Inc. #1San DiegoUnited StatesUnknown status
Pacific Research Network, Inc. #2San DiegoUnited StatesUnknown status
Syrentis Clinical ResearchSanta AnaUnited StatesUnknown status
HB Clinical Trials Inc.Santa AnaUnited StatesUnknown status
Roskamp InstituteSarasotaUnited StatesUnknown status
Perseverance Research Center, LLCScottsdaleUnited StatesUnknown status
BG NeurologySpartanburgUnited StatesUnknown status
Richmond Behavioral AssociatesStaten IslandUnited StatesUnknown status
VICIS Clinical Research Inc. Site #777TampaUnited StatesUnknown status
Olympian Clinical ResearchTampaUnited StatesUnknown status
Viking Clinical ResearchTemeculaUnited StatesUnknown status
Compass Research North, LLCThe VillagesUnited StatesUnknown status
Bio Behavioral HealthToms RiverUnited StatesUnknown status
Oakland Medical Research Site #762TroyUnited StatesUnknown status
IPC ResearchWaukeshaUnited StatesUnknown status
Neurology Research Institute Palm Beach, LLC #1West Palm BeachUnited StatesUnknown status
Neurology Research Institute Palm Beach, LLC #2West Palm BeachUnited StatesUnknown status
Burke Rehabilitation HospitalWhite PlainsUnited StatesUnknown status
Abington Neurological Associates LtdWillow GroveUnited StatesUnknown status
Florida Premier Research InstituteWinter ParkUnited StatesUnknown status
Neuropsychiatric AssociatesWoodstockUnited StatesUnknown status
Cape Trial CentreCape TownSouth AfricaUnknown status
Flexivest Fourteen Research CentreCape TownSouth AfricaUnknown status
ACF Neurological ServicesCape TownSouth AfricaUnknown status
-JohannesburgSouth AfricaUnknown status
Medical and Dental CentreRosebankSouth AfricaUnknown status

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