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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

Primary Purpose

Agitation in Patients With Dementia of the Alzheimer's Type

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
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

Eligibility Criteria

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

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

Sites / Locations

  • Brain and Spine Center
  • MD First Research, LLCRecruiting
  • Banner Alzheimer's Institute
  • NoesisPharma, LLC
  • Perseverance Research Center, LLC
  • Health Initiatives Research
  • Advanced Research Center, Inc.Recruiting
  • ATP Clinical Research, Inc.Recruiting
  • Behavioral Research Specialists, LLC
  • Irvine Center for Clinical Research
  • University of California, Irvine
  • Omega Clinical Trials, LLC
  • Collaborative Neuroscience Network, LLC.
  • Alliance for Wellness, Inc dba Alliance for ResearchRecruiting
  • Shankle Clinic
  • NRC Research Institute
  • California Neurological Services
  • Havana Research Institute Site 787
  • Havana Research Institute
  • Pacific Research Network, Inc. #1
  • Pacific Research Network, Inc. #2
  • VA San Diego Healthcare System
  • HB Clinical Trials Inc.
  • Syrentis Clinical Research
  • Viking Clinical Research
  • New Foundation Medical Group Clinical Trials
  • Lytle and Weiss, PLLC dba Clinical Trials of the Rockies
  • Connecticut Clinical Research
  • Associated Neurologists, PC
  • Geriatric and Adult Psychiatry LLC
  • Coastal Connecticut Research, LLC
  • Research Center for Clinical Studies, Inc.
  • JEM Research Institute
  • Negron Research Services / Humanity Clinical Research Site# 766Recruiting
  • Neurology Offices of South Florida
  • SFM Clinical Research, LLCRecruiting
  • Bradenton Research CenterRecruiting
  • Clinical Research Of Brandon, LLC
  • Meridien Research
  • Quantum Laboratories, Inc.
  • Moonshine Research Center, Inc
  • Science Connections, LLCRecruiting
  • University of Florida
  • Finlay Medical Research Corp
  • Direct Helpers Research Center
  • Indago Research & Health Center, Inc.
  • New Life Medical Research Center, Inc.
  • Reliable Clinical Research,LLC
  • Research in Miami, Inc
  • The Research Center, Inc
  • Berma Research Group
  • Galiz Research
  • Maxblue Institute
  • New Med Research, IncRecruiting
  • Clinical Neuroscience Solutions, Inc.
  • SIH Research, LLC
  • Alzheimer's Research and Treatment Center #1
  • Alzheimer's Research and Treatment Center #2
  • Alzheimer's Research and Treatment Center #3
  • Meridien Research Site #558
  • Innovative Clinical Research, Inc.Recruiting
  • Agility Clinical Research, Inc.
  • Homestead Associates in Research Site# 797Recruiting
  • Premier Clinical Research Institute, Inc. #1
  • Premier Clinical Research Institute, Inc. #2
  • Central Miami Medical InstituteRecruiting
  • Global Medical Institutes, LLC
  • Optimus U Corp
  • Project 4 Research #1
  • Project 4 Research #2
  • BioMed Research Institute
  • Finlay Medical Research CorpRecruiting
  • First Class Medical ServicesRecruiting
  • CCM Clinical Research Group
  • Innova Clinical Trials
  • Advance Medical Research Center #1
  • Advance Medical Research Center #2
  • Dade Research Center Llc
  • Vitae Researrch Center LLC
  • University of Miami
  • Miami Jewish Health Systems, Inc.
  • AMB Research Center, Inc.
  • United Health Research Corp. #1
  • United Health Research Corp. #2
  • Advanced Medical Center Group
  • Future Care Solution, LLC
  • Reliant Medical Research LLCRecruiting
  • Clinical Research Associates of South Florida #1
  • Clinical Research Associates of South Florida #2
  • Coral Research Clinic Corp
  • P&S Research, Llc.Recruiting
  • Pharmax Research of South FloridaRecruiting
  • Miami Dade Medical Research Institute, LLC
  • The Neurology Research Group, LLC
  • International Research Associates, LLC
  • Kendall Research Institute
  • Nuovida Research Center Corp.
  • Research Institute of West Kendall
  • Collier Neurologic Specialists, LLC
  • Naples Research, Inc
  • Bayside Clinical ResearchRecruiting
  • Lazlo J. Mate, MD, PA
  • Research Centers of America, LLC
  • Sensible Healthcare
  • Compass Research, LLC
  • Neurology Associates of Ormond Beach
  • Innovation Medical Research Center
  • IMIC Inc.
  • Innovation Medical Research CenterRecruiting
  • University of West Florida
  • Neurostudies Inc. Site#796Recruiting
  • Suncoast Neuroscience Associates, Inc.
  • Roskamp Institute
  • Olympian Clinical Research
  • University of South Florida
  • VICIS Clinical Research Inc.Recruiting
  • Compass Research North, LLC
  • Neurology Research Institute Palm Beach, LLC #1
  • Neurology Research Institute Palm Beach, LLC #2
  • Florida Premier Research Institute
  • Emory Brain Health Center
  • NeuroTrials Research Inc
  • Columbus Research & Wellness Institute, INC
  • Medical Research & Health Education Foundation, Inc.
  • NeuroStudies. Net, LLC
  • Alexian Brothers Neurosciences Institute
  • Behavioral Health Care Associates
  • Indiana University School of Medicine
  • Josephson Wallack Munshower Neurology, PC
  • MidAmerica Neuroscience Research Foundation
  • Four Rivers Clinical Research Inc.
  • J. Gary Booker, MD, APMC
  • The Samuel & Alexia Bratton Memory Clinic
  • Mir Neurology
  • Bedford VA Hospital
  • Boston Center for Memory
  • Alzheimer's Disease Center
  • Onyx Clinical Research, LLC
  • Michigan State University Department of Neurology
  • Bronson Neurobehavioral Health
  • Galen Research
  • Millennium Psychiatric Associates, LLC
  • Saint Luke's Hospital of Kansas City
  • PsychCare Consultants Research
  • Clinical Research Professionals
  • Geriatric Solutions, LLC
  • Flora Baker Center for Alzheimer's Disease and Related Disorders
  • The NeuroCognitive Institute
  • Bio Behavioral Health
  • Dent Neurologic Institute
  • Brooklyn Medical Institute
  • Integrative Clinical Trials LLC #1
  • Integrative Clinical Trials LLC #2
  • Columbia University Medical Center
  • Manhattan Behavioral Medicine, PLLC
  • Eastside Comprehensive Medical Center, LLC
  • Nathan S. Kline Institute for Psychiatric Research #1
  • Nathan S. Kline Institute for Psychiatric Research #571
  • University of Rochester Medical Center
  • Psychiatry and Alzheimer's Care of Rochester, PLLC
  • Richmond Behavioral Associates
  • Burke Rehabilitation Hospital
  • Herbert Harris, Md, Phd, Pa
  • ANI Neurology PLLC dba Alzheimer's Memory Center
  • Duke University Medical Center
  • Daystar Clinical Research Inc
  • Neurology and Neuroscience Associates, Inc.
  • Insight Clinical Trials, LLCRecruiting
  • Insight Neuroscience, LLC
  • Valley Medical Research Site #788
  • Valley Medical Research
  • CTI Clinical Research Center
  • University of Cincinnati
  • The Ohio State University
  • Cleveland Clinic Lou Ruvo Center for Brain Health at Lakewood Hospital
  • NorthStar Medical ResearchRecruiting
  • IPS Research Company
  • Oklahoma Clinical Research Center
  • Tulsa Clinical Research, LLC
  • Heritage Valley Medical Group, Inc.
  • The Birches at Newton / Family Medical Associates
  • Drexel University
  • Thomas Jefferson University
  • Abington Neurological Associates, LTD
  • Rhode Island Mood & Memory Research Institute
  • RH Johnson VA Medical Center
  • Roper St. Francis Healthcare
  • Coastal Neurology, PA
  • BG Neurology
  • Neurology Clinic, P.C.
  • Clinical Research Solutions
  • Texas Neurology, P.A.
  • Neurology Consultants of Dallas, PA
  • University Texas Southwestern Medical Center
  • InSite Clinical Research Site #576
  • Baylor College of Medicine
  • Houston Methodist Neurological Institute
  • University Hills Clinical Research
  • Neurology Associates of Arlington
  • Wellness Clinical Research
  • PRX ResearchRecruiting
  • Texas Medical Research Associates, L.L.C.
  • Ericksen Research and Development
  • Pharmaceuticals Research Associates, Inc.
  • Clinical Neuroscience Research Associates, Inc. dba The Memory Clinic
  • Neuropsychiatric Associates
  • Sentara Neurosciences Institute
  • Veteran Affairs Medical Center, Salem Virginia
  • Northwest Clinical Research Center
  • Core Clinical ResearchRecruiting
  • Frontier Institute
  • IPC Research
  • Center for Mental Health - RuseRecruiting
  • Mental Health Centre Prof. Nikola ShipkovenskiRecruiting
  • Medical Center Sveti NaumRecruiting
  • Vrach and Sv. Sv. Kuzma and DamianRecruiting
  • University Multiprofile Hospital for Active Treatment AlexandrovskaRecruiting
  • Medical Center Mladost-MRecruiting
  • Medica Plus Medical CenterRecruiting
  • Dr. Alexander McIntyre Inc.
  • Fakultni Nemocnice u sv. Anny v BrneRecruiting
  • Fakultní Nemocnice Hradec KrálovéRecruiting
  • NeuropsychiatrieHKRecruiting
  • Brain-SoultherapyRecruiting
  • Námestí národního odboje 692Recruiting
  • A-Shine s.r.o. Site #731
  • AD71Recruiting
  • ClintrialRecruiting
  • Neurologicka Ambulance - ForbeliRecruiting
  • NeuropsychiatrieRecruiting
  • Vestra ClinicsRecruiting
  • Centre Hospitalier Universitaire Dijon BourgognRecruiting
  • Centre Hospitalier Universitaire de Saint-Étienne - Hôpital NordRecruiting
  • Centre Hospitalier Universitaire Toulouse - Casselardit AncelyRecruiting
  • Dr. Kenessey Albert Kórház-Rendelőintézet
  • Pszichiatriai es Pszichiatriai Rehabilitacios OsztalyRecruiting
  • Semmelweis EgyetemRecruiting
  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
  • Dr. Mathe es Tarsa Beteti TarsasagRecruiting
  • PsychoTechRecruiting
  • Azienda Ospedaliera Sant'AndreaRecruiting
  • Fondazione Policlinico Tor VergataRecruiting
  • Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico
  • Ksiedza Hugona Kollataja 9Recruiting
  • Care ClinicRecruiting
  • Wielospecjalistyczna Poradnia Lekarska SynapsisRecruiting
  • Krakowska Akademia NeurologiiRecruiting
  • Malopolskie Centrum MedyczneRecruiting
  • Medycyna MilorzabRecruiting
  • Solumed Centrum MedyczneRecruiting
  • Centrum Medyczne Euromedis
  • Centrum Medyczne NeuroProtectRecruiting
  • ClinHouse Centrum MedyczneRecruiting
  • ACF Neurological Services
  • Cape Trial CentreRecruiting
  • Flexivest Fourteen Research CentreRecruiting
  • Apollo Clinical ResearchRecruiting
  • Medical and Dental CentreRecruiting
  • Accellacare AlcobendasRecruiting
  • Fundació ACE
  • Hospital Clinic de Barcelona
  • Hospital General Universitario de ElcheRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Complejo Asistencial de Zamora Hospital Virgen de la ConchaRecruiting
  • Hospital Viamed MontecanalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

AVP-786 (dose 1)

AVP-786 (dose 2)

AVP-786 (dose 3)

Arm Description

AVP-786 dose 1; capsules administered twice a day over a 52-week period

AVP-786 dose 2; capsules administered twice a day over a 52-week period

AVP-786 dose 3; capsules administered twice a day over a 52-week period

Outcomes

Primary Outcome Measures

Number of Participants with any Treatment-Emergent Adverse Event
Number of Participants with any Treatment-Emergent Serious Adverse Event
Number of Participants with any abnormal, clinically significant Clinical Laboratory Value
Number of Participants with any abnormal, clinically significant 12-lead Electrocardiogram (ECG) value
Number of Participants with any abnormal, clinically significant Physical and Neurological Examination finding
Number of participants with any abnormal, clinically significant vital sign value
Change from Baseline to Week 64 in the Sheehan Suicidality Tracking Scale (S-STS) Score
Change from Baseline to Week 52 in the Mini-Mental State Examination (MMSE) Score
Change from Baseline to Week 52 in the Epworth Sleepiness Scale (ESS) Score

Secondary Outcome Measures

Change from Baseline to Week 64 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score
Change from Baseline to Week 52 in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI)
Change from Baseline to Week 64 in the modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score
Change from Baseline to Week 52 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score
Change from Baseline to Week 52 in the Patient Global Impression of Change (PGIC) Score
PGIC (rated by caregiver)
Change from Baseline to Week 52 in the Dementia Quality of Life (DEMQOL) Score
Change from Baseline to Week 52 in the Resource Utilization in Dementia (RUD) Score
Change from Baseline to Week 52 in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) for Participants from Study 17-AVP-786-305

Full Information

First Posted
May 11, 2015
Last Updated
October 20, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02446132
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (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 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.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AVP-786 (dose 1)
Arm Type
Experimental
Arm Description
AVP-786 dose 1; capsules administered twice a day over a 52-week period
Arm Title
AVP-786 (dose 2)
Arm Type
Experimental
Arm Description
AVP-786 dose 2; capsules administered twice a day over a 52-week period
Arm Title
AVP-786 (dose 3)
Arm Type
Experimental
Arm Description
AVP-786 dose 3; capsules administered twice a day over a 52-week period
Intervention Type
Drug
Intervention Name(s)
AVP-786
Primary Outcome Measure Information:
Title
Number of Participants with any Treatment-Emergent Adverse Event
Time Frame
up to 64 weeks
Title
Number of Participants with any Treatment-Emergent Serious Adverse Event
Time Frame
up to 64 weeks
Title
Number of Participants with any abnormal, clinically significant Clinical Laboratory Value
Time Frame
up to 52 weeks
Title
Number of Participants with any abnormal, clinically significant 12-lead Electrocardiogram (ECG) value
Time Frame
up to 52 weeks
Title
Number of Participants with any abnormal, clinically significant Physical and Neurological Examination finding
Time Frame
up to 52 weeks
Title
Number of participants with any abnormal, clinically significant vital sign value
Time Frame
up to 52 weeks
Title
Change from Baseline to Week 64 in the Sheehan Suicidality Tracking Scale (S-STS) Score
Time Frame
Baseline; Week 64
Title
Change from Baseline to Week 52 in the Mini-Mental State Examination (MMSE) Score
Time Frame
Baseline; Week 52
Title
Change from Baseline to Week 52 in the Epworth Sleepiness Scale (ESS) Score
Time Frame
Baseline; Week 52
Secondary Outcome Measure Information:
Title
Change from Baseline to Week 64 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score
Time Frame
Baseline; Week 64
Title
Change from Baseline to Week 52 in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI)
Time Frame
Baseline; Week 52
Title
Change from Baseline to Week 64 in the modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score
Time Frame
Baseline; Week 64
Title
Change from Baseline to Week 52 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score
Time Frame
Baseline; Week 52
Title
Change from Baseline to Week 52 in the Patient Global Impression of Change (PGIC) Score
Description
PGIC (rated by caregiver)
Time Frame
Baseline; Week 52
Title
Change from Baseline to Week 52 in the Dementia Quality of Life (DEMQOL) Score
Time Frame
Baseline; Week 52
Title
Change from Baseline to Week 52 in the Resource Utilization in Dementia (RUD) Score
Time Frame
Baseline; Week 52
Title
Change from Baseline to Week 52 in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) for Participants from Study 17-AVP-786-305
Time Frame
Baseline; Week 52
Other Pre-specified Outcome Measures:
Title
Number of participants using concomitant medications
Time Frame
up to 64 weeks

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Otsuka Call Center
Phone
844-687-8522
Email
OtsukaRMReconciliation@rmpdc.org
Facility Information:
Facility Name
Brain and Spine Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85226
Country
United States
Individual Site Status
Withdrawn
Facility Name
MD First Research, LLC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85286
Country
United States
Individual Site Status
Recruiting
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Withdrawn
Facility Name
NoesisPharma, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Completed
Facility Name
Perseverance Research Center, LLC
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Individual Site Status
Completed
Facility Name
Health Initiatives Research
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Individual Site Status
Completed
Facility Name
Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Recruiting
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Individual Site Status
Recruiting
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Completed
Facility Name
Irvine Center for Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Individual Site Status
Completed
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Withdrawn
Facility Name
Omega Clinical Trials, LLC
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
Individual Site Status
Withdrawn
Facility Name
Collaborative Neuroscience Network, LLC.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Completed
Facility Name
Alliance for Wellness, Inc dba Alliance for Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Individual Site Status
Recruiting
Facility Name
Shankle Clinic
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Withdrawn
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Completed
Facility Name
California Neurological Services
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Individual Site Status
Completed
Facility Name
Havana Research Institute Site 787
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Havana Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Completed
Facility Name
Pacific Research Network, Inc. #1
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Completed
Facility Name
Pacific Research Network, Inc. #2
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Completed
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Withdrawn
Facility Name
HB Clinical Trials Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Individual Site Status
Completed
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Completed
Facility Name
Viking Clinical Research
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Individual Site Status
Completed
Facility Name
New Foundation Medical Group Clinical Trials
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Individual Site Status
Withdrawn
Facility Name
Lytle and Weiss, PLLC dba Clinical Trials of the Rockies
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Individual Site Status
Completed
Facility Name
Connecticut Clinical Research
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Individual Site Status
Withdrawn
Facility Name
Associated Neurologists, PC
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Individual Site Status
Withdrawn
Facility Name
Geriatric and Adult Psychiatry LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Individual Site Status
Withdrawn
Facility Name
Coastal Connecticut Research, LLC
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Individual Site Status
Completed
Facility Name
Research Center for Clinical Studies, Inc.
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Individual Site Status
Completed
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Individual Site Status
Completed
Facility Name
Negron Research Services / Humanity Clinical Research Site# 766
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurology Offices of South Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Individual Site Status
Withdrawn
Facility Name
SFM Clinical Research, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Individual Site Status
Recruiting
Facility Name
Bradenton Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Of Brandon, LLC
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Completed
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Individual Site Status
Completed
Facility Name
Quantum Laboratories, Inc.
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Individual Site Status
Completed
Facility Name
Moonshine Research Center, Inc
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Completed
Facility Name
Science Connections, LLC
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Withdrawn
Facility Name
Finlay Medical Research Corp
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Individual Site Status
Completed
Facility Name
Direct Helpers Research Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Withdrawn
Facility Name
Indago Research & Health Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Completed
Facility Name
New Life Medical Research Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Completed
Facility Name
Reliable Clinical Research,LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Completed
Facility Name
Research in Miami, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Individual Site Status
Completed
Facility Name
The Research Center, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Individual Site Status
Completed
Facility Name
Berma Research Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Completed
Facility Name
Galiz Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Completed
Facility Name
Maxblue Institute
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33018
Country
United States
Individual Site Status
Completed
Facility Name
New Med Research, Inc
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33020
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Completed
Facility Name
SIH Research, LLC
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Completed
Facility Name
Alzheimer's Research and Treatment Center #1
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Individual Site Status
Completed
Facility Name
Alzheimer's Research and Treatment Center #2
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Individual Site Status
Completed
Facility Name
Alzheimer's Research and Treatment Center #3
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Individual Site Status
Completed
Facility Name
Meridien Research Site #558
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Innovative Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Individual Site Status
Recruiting
Facility Name
Agility Clinical Research, Inc.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Withdrawn
Facility Name
Homestead Associates in Research Site# 797
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Name
Premier Clinical Research Institute, Inc. #1
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Individual Site Status
Completed
Facility Name
Premier Clinical Research Institute, Inc. #2
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Individual Site Status
Completed
Facility Name
Central Miami Medical Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Name
Global Medical Institutes, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Completed
Facility Name
Optimus U Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Completed
Facility Name
Project 4 Research #1
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Completed
Facility Name
Project 4 Research #2
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Completed
Facility Name
BioMed Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Completed
Facility Name
Finlay Medical Research Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
First Class Medical Services
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
CCM Clinical Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Individual Site Status
Completed
Facility Name
Innova Clinical Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Individual Site Status
Completed
Facility Name
Advance Medical Research Center #1
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Completed
Facility Name
Advance Medical Research Center #2
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Completed
Facility Name
Dade Research Center Llc
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Completed
Facility Name
Vitae Researrch Center LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Completed
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Completed
Facility Name
Miami Jewish Health Systems, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Individual Site Status
Completed
Facility Name
AMB Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Withdrawn
Facility Name
United Health Research Corp. #1
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Completed
Facility Name
United Health Research Corp. #2
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Completed
Facility Name
Advanced Medical Center Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Individual Site Status
Terminated
Facility Name
Future Care Solution, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Completed
Facility Name
Reliant Medical Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Associates of South Florida #1
City
Miami
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Individual Site Status
Completed
Facility Name
Clinical Research Associates of South Florida #2
City
Miami
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Individual Site Status
Terminated
Facility Name
Coral Research Clinic Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Completed
Facility Name
P&S Research, Llc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Pharmax Research of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami Dade Medical Research Institute, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Neurology Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Withdrawn
Facility Name
International Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Individual Site Status
Withdrawn
Facility Name
Kendall Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Individual Site Status
Completed
Facility Name
Nuovida Research Center Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Completed
Facility Name
Research Institute of West Kendall
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Withdrawn
Facility Name
Collier Neurologic Specialists, LLC
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Completed
Facility Name
Naples Research, Inc
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Terminated
Facility Name
Bayside Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Individual Site Status
Recruiting
Facility Name
Lazlo J. Mate, MD, PA
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Centers of America, LLC
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Individual Site Status
Completed
Facility Name
Sensible Healthcare
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Withdrawn
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Completed
Facility Name
Neurology Associates of Ormond Beach
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Completed
Facility Name
Innovation Medical Research Center
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
03157
Country
United States
Individual Site Status
Completed
Facility Name
IMIC Inc.
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Completed
Facility Name
Innovation Medical Research Center
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Recruiting
Facility Name
University of West Florida
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Individual Site Status
Completed
Facility Name
Neurostudies Inc. Site#796
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Individual Site Status
Recruiting
Facility Name
Suncoast Neuroscience Associates, Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Individual Site Status
Withdrawn
Facility Name
Roskamp Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Individual Site Status
Completed
Facility Name
Olympian Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Completed
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Withdrawn
Facility Name
VICIS Clinical Research Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Name
Compass Research North, LLC
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Individual Site Status
Completed
Facility Name
Neurology Research Institute Palm Beach, LLC #1
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Completed
Facility Name
Neurology Research Institute Palm Beach, LLC #2
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Completed
Facility Name
Florida Premier Research Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Completed
Facility Name
Emory Brain Health Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Withdrawn
Facility Name
NeuroTrials Research Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Completed
Facility Name
Columbus Research & Wellness Institute, INC
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Completed
Facility Name
Medical Research & Health Education Foundation, Inc.
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Individual Site Status
Completed
Facility Name
NeuroStudies. Net, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Individual Site Status
Completed
Facility Name
Alexian Brothers Neurosciences Institute
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Individual Site Status
Withdrawn
Facility Name
Behavioral Health Care Associates
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Individual Site Status
Withdrawn
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Completed
Facility Name
Josephson Wallack Munshower Neurology, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Individual Site Status
Completed
Facility Name
MidAmerica Neuroscience Research Foundation
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Individual Site Status
Completed
Facility Name
Four Rivers Clinical Research Inc.
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Individual Site Status
Completed
Facility Name
J. Gary Booker, MD, APMC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Samuel & Alexia Bratton Memory Clinic
City
Easton
State/Province
Maryland
ZIP/Postal Code
21601
Country
United States
Individual Site Status
Completed
Facility Name
Mir Neurology
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Individual Site Status
Completed
Facility Name
Bedford VA Hospital
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States
Individual Site Status
Withdrawn
Facility Name
Boston Center for Memory
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Individual Site Status
Completed
Facility Name
Alzheimer's Disease Center
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Individual Site Status
Completed
Facility Name
Onyx Clinical Research, LLC
City
Caro
State/Province
Michigan
ZIP/Postal Code
48723
Country
United States
Individual Site Status
Terminated
Facility Name
Michigan State University Department of Neurology
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Completed
Facility Name
Bronson Neurobehavioral Health
City
Paw Paw
State/Province
Michigan
ZIP/Postal Code
49079
Country
United States
Individual Site Status
Withdrawn
Facility Name
Galen Research
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Individual Site Status
Terminated
Facility Name
Millennium Psychiatric Associates, LLC
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Completed
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Withdrawn
Facility Name
PsychCare Consultants Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Professionals
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Withdrawn
Facility Name
Geriatric Solutions, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Individual Site Status
Withdrawn
Facility Name
Flora Baker Center for Alzheimer's Disease and Related Disorders
City
Marmora
State/Province
New Jersey
ZIP/Postal Code
08223
Country
United States
Individual Site Status
Withdrawn
Facility Name
The NeuroCognitive Institute
City
Mount Arlington
State/Province
New Jersey
ZIP/Postal Code
07856
Country
United States
Individual Site Status
Completed
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Individual Site Status
Completed
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Completed
Facility Name
Brooklyn Medical Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
Individual Site Status
Withdrawn
Facility Name
Integrative Clinical Trials LLC #1
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Individual Site Status
Completed
Facility Name
Integrative Clinical Trials LLC #2
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Individual Site Status
Completed
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Completed
Facility Name
Manhattan Behavioral Medicine, PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Individual Site Status
Completed
Facility Name
Eastside Comprehensive Medical Center, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Individual Site Status
Completed
Facility Name
Nathan S. Kline Institute for Psychiatric Research #1
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Individual Site Status
Completed
Facility Name
Nathan S. Kline Institute for Psychiatric Research #571
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Individual Site Status
Completed
Facility Name
Psychiatry and Alzheimer's Care of Rochester, PLLC
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Individual Site Status
Withdrawn
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Individual Site Status
Completed
Facility Name
Burke Rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Individual Site Status
Completed
Facility Name
Herbert Harris, Md, Phd, Pa
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Individual Site Status
Completed
Facility Name
ANI Neurology PLLC dba Alzheimer's Memory Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28270
Country
United States
Individual Site Status
Completed
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Completed
Facility Name
Daystar Clinical Research Inc
City
Akron
State/Province
Ohio
ZIP/Postal Code
44313
Country
United States
Individual Site Status
Withdrawn
Facility Name
Neurology and Neuroscience Associates, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44320
Country
United States
Individual Site Status
Completed
Facility Name
Insight Clinical Trials, LLC
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Individual Site Status
Recruiting
Facility Name
Insight Neuroscience, LLC
City
Bellevue
State/Province
Ohio
ZIP/Postal Code
44811
Country
United States
Individual Site Status
Withdrawn
Facility Name
Valley Medical Research Site #788
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Terminated
Facility Name
Valley Medical Research
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Completed
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Completed
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Completed
Facility Name
Cleveland Clinic Lou Ruvo Center for Brain Health at Lakewood Hospital
City
Lakewood
State/Province
Ohio
ZIP/Postal Code
44107
Country
United States
Individual Site Status
Completed
Facility Name
NorthStar Medical Research
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Individual Site Status
Completed
Facility Name
Oklahoma Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Completed
Facility Name
Tulsa Clinical Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Withdrawn
Facility Name
Heritage Valley Medical Group, Inc.
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Individual Site Status
Completed
Facility Name
The Birches at Newton / Family Medical Associates
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Individual Site Status
Withdrawn
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Withdrawn
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Withdrawn
Facility Name
Abington Neurological Associates, LTD
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Individual Site Status
Completed
Facility Name
Rhode Island Mood & Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Individual Site Status
Completed
Facility Name
RH Johnson VA Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Individual Site Status
Completed
Facility Name
Roper St. Francis Healthcare
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Individual Site Status
Completed
Facility Name
Coastal Neurology, PA
City
Port Royal
State/Province
South Carolina
ZIP/Postal Code
29935
Country
United States
Individual Site Status
Withdrawn
Facility Name
BG Neurology
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Individual Site Status
Completed
Facility Name
Neurology Clinic, P.C.
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Solutions
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Neurology, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Individual Site Status
Completed
Facility Name
Neurology Consultants of Dallas, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Completed
Facility Name
University Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8898
Country
United States
Individual Site Status
Completed
Facility Name
InSite Clinical Research Site #576
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Individual Site Status
Completed
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Completed
Facility Name
Houston Methodist Neurological Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Completed
Facility Name
University Hills Clinical Research
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Individual Site Status
Withdrawn
Facility Name
Neurology Associates of Arlington
City
Mansfield
State/Province
Texas
ZIP/Postal Code
76063
Country
United States
Individual Site Status
Withdrawn
Facility Name
Wellness Clinical Research
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
PRX Research
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Medical Research Associates, L.L.C.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78238
Country
United States
Individual Site Status
Completed
Facility Name
Ericksen Research and Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Individual Site Status
Completed
Facility Name
Pharmaceuticals Research Associates, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Completed
Facility Name
Clinical Neuroscience Research Associates, Inc. dba The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Individual Site Status
Completed
Facility Name
Neuropsychiatric Associates
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Individual Site Status
Completed
Facility Name
Sentara Neurosciences Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Individual Site Status
Withdrawn
Facility Name
Veteran Affairs Medical Center, Salem Virginia
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Individual Site Status
Completed
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Completed
Facility Name
Core Clinical Research
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Name
Frontier Institute
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Withdrawn
Facility Name
IPC Research
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Individual Site Status
Completed
Facility Name
Center for Mental Health - Ruse
City
Ruse
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Mental Health Centre Prof. Nikola Shipkovenski
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Sveti Naum
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Vrach and Sv. Sv. Kuzma and Damian
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University Multiprofile Hospital for Active Treatment Alexandrovska
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Mladost-M
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medica Plus Medical Center
City
Veliko Tarnovo
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Dr. Alexander McIntyre Inc.
City
Penticton
Country
Canada
Individual Site Status
Completed
Facility Name
Fakultni Nemocnice u sv. Anny v Brne
City
Brno
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultní Nemocnice Hradec Králové
City
Hradec Kralové
Country
Czechia
Individual Site Status
Recruiting
Facility Name
NeuropsychiatrieHK
City
Hradec Kralové
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Brain-Soultherapy
City
Kladno
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Námestí národního odboje 692
City
Kutna Hora
Country
Czechia
Individual Site Status
Recruiting
Facility Name
A-Shine s.r.o. Site #731
City
Plzen
Country
Czechia
Individual Site Status
Completed
Facility Name
AD71
City
Praha
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Clintrial
City
Praha
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Neurologicka Ambulance - Forbeli
City
Praha
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Neuropsychiatrie
City
Praha
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vestra Clinics
City
Rychnov nad Kněžnou
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Dijon Bourgogn
City
Dijon Cedex
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord
City
Saint-Etienne
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Toulouse - Casselardit Ancely
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Name
Dr. Kenessey Albert Kórház-Rendelőintézet
City
Balassagyarmat
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Pszichiatriai es Pszichiatriai Rehabilitacios Osztaly
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
City
Debrecen
Country
Hungary
Individual Site Status
Terminated
Facility Name
Dr. Mathe es Tarsa Beteti Tarsasag
City
Kalocsa
ZIP/Postal Code
6300
Country
Hungary
Individual Site Status
Recruiting
Facility Name
PsychoTech
City
Pécs
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Sant'Andrea
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Tor Vergata
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico
City
Roma
Country
Italy
Individual Site Status
Completed
Facility Name
Ksiedza Hugona Kollataja 9
City
Bydgoszcz
Country
Poland
Individual Site Status
Recruiting
Facility Name
Care Clinic
City
Katowice
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wielospecjalistyczna Poradnia Lekarska Synapsis
City
Katowice
Country
Poland
Individual Site Status
Recruiting
Facility Name
Krakowska Akademia Neurologii
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Name
Malopolskie Centrum Medyczne
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Name
Medycyna Milorzab
City
Lodz
Country
Poland
Individual Site Status
Recruiting
Facility Name
Solumed Centrum Medyczne
City
Poznań
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Euromedis
City
Szczecin
Country
Poland
Individual Site Status
Terminated
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
Country
Poland
Individual Site Status
Recruiting
Facility Name
ClinHouse Centrum Medyczne
City
Zabrze
ZIP/Postal Code
41-807
Country
Poland
Individual Site Status
Recruiting
Facility Name
ACF Neurological Services
City
Cape Town
Country
South Africa
Individual Site Status
Completed
Facility Name
Cape Trial Centre
City
Cape Town
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Flexivest Fourteen Research Centre
City
Cape Town
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Apollo Clinical Research
City
Johannesburg
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Medical and Dental Centre
City
Rosebank
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Accellacare Alcobendas
City
Alcobendas
ZIP/Postal Code
28100
Country
Spain
Individual Site Status
Recruiting
Facility Name
Fundació ACE
City
Barcelona
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital General Universitario de Elche
City
Elche
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Asistencial de Zamora Hospital Virgen de la Concha
City
Zamora
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Viamed Montecanal
City
Zaragoza
Country
Spain
Individual Site Status
Recruiting

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

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

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