search
Back to results

Study to Assess the Efficacy, Safety, and Tolerability 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
Placebo
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria
  • Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment
  • Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions
  • Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
  • Participants meeting an additional predetermined blinded eligibility criterion, which will remain blinded to the clinical study site Investigators and staff
  • Participants with a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends 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 Alzheimer's dementia (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 [except skin basal-cell carcinoma], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
  • Participants with myasthenia gravis

Sites / Locations

  • Clinical Research SiteRecruiting
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site #840-047
  • Clinical Research Site
  • Clinical Research Site #840-059
  • Clinical Research Site #840-048
  • Clinical Research SiteRecruiting
  • Clinical Research Site #840-046Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site #840-025
  • Clinical Research Site #840-070Recruiting
  • Clinical Research Site #840-055
  • Clinical Research Site #840-066Recruiting
  • Clinical Research Site
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #840-041
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #840-049Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site# 840-061
  • Clinical Research Site
  • Clinical Research Site #840-030Recruiting
  • Clinical Research Site #840-073Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site
  • Clinical Research Site #840-014
  • Clinical Research Site #840-022Recruiting
  • Clinical Research Site #840-024
  • Clinical Research Site #840-063
  • Clinical Research Site #840-043Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #840-035
  • Clinical Research Site #840-053
  • Clinical Research Site #840-072Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #056-004Recruiting
  • Clinical Research Site #056-003Recruiting
  • Clinical Research Site # 056-002Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site# 124-007
  • Clinical Research Site
  • Clinical Research SiteRecruiting
  • Clinical Research Site #124-002
  • Clinical Research Site #152-002Recruiting
  • Clinical Research Site # 152-005Recruiting
  • Clinical Research Site #152-001Recruiting
  • Clinical Research Site #152-006Recruiting
  • Clinical Research Site #152-003Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site# 191-006Recruiting
  • Clinical Research Site# 191-001Recruiting
  • Clinical Research Site #191-003Recruiting
  • Clinical Research Site #191-005Recruiting
  • Clinical Research Site #191-002Recruiting
  • Clinical Research Site #191-004Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #1Recruiting
  • Clinical Research Site #2Recruiting
  • Clinical Research Site #348-004Recruiting
  • Clinical Research Site #484-008Recruiting
  • Clinical Research Site # 484-004Recruiting
  • Clinical Research Site #484-006Recruiting
  • Clinical Research Site #484-005Recruiting
  • Clinical Research Site # 484-003Recruiting
  • Clinical Research Site #484-010Recruiting
  • Clinical Research Site # 484-002Recruiting
  • Clinical Research Site #484-009Recruiting
  • Clinical Trial Site #528-001Recruiting
  • Clinical Research Site #703-009Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #703-006
  • Clinical Research SiteRecruiting
  • Clinical Research Site #703-005Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #705-005Recruiting
  • Clinical Research Site #705-001Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #724-010Recruiting
  • Clinical Research Site # 724-007Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AVP-786

Placebo

Arm Description

Participants will be assigned to treatment with AVP-786 capsules administered twice a day over a 12-week period.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Score, as Related to Agitation

Full Information

First Posted
July 6, 2020
Last Updated
August 3, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04464564
Brief Title
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.
Detailed Description
Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD. This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment. Approximately 750 participants will be enrolled at approximately 110 centers worldwide. Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation. Participants meeting an additional predetermined blinded eligibility criterion, which will remain blinded to the clinical study site Investigators and staff Participants with a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends 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 Alzheimer's dementia (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 [except skin basal-cell carcinoma], 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
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
Clinical Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site #840-047
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site #840-059
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site #840-048
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-046
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site #840-025
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site #840-070
City
Apopka
State/Province
Florida
ZIP/Postal Code
32703
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-055
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site #840-066
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-041
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34105
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32502
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-049
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site# 840-061
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site #840-030
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-073
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site #840-014
City
Bloomfield Township
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site #840-022
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-024
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site #840-063
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site #840-043
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14030
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-035
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site #840-053
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site #840-072
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77077
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22311
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #056-004
City
Brussel
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #056-003
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Clinical Research Site # 056-002
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Research Site# 124-007
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #124-002
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site #152-002
City
Antofagasta
ZIP/Postal Code
1270244
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clinical Research Site # 152-005
City
Independencia
ZIP/Postal Code
8380456
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #152-001
City
Santiago de Chile
ZIP/Postal Code
7500710
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #152-006
City
Santiago de Chile
ZIP/Postal Code
9120000
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #152-003
City
Santiago
ZIP/Postal Code
7560356
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Bogota
State/Province
Columbia
ZIP/Postal Code
111166
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Pereira
State/Province
Columbia
ZIP/Postal Code
1111
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Florida Blanca
State/Province
Santander
ZIP/Postal Code
111511
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Bello
ZIP/Postal Code
051050
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Bogota
ZIP/Postal Code
110231
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Bogotá
ZIP/Postal Code
110231
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site# 191-006
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site# 191-001
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #191-003
City
Zagreb
ZIP/Postal Code
1000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #191-005
City
Zagreb
ZIP/Postal Code
HR 10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #191-002
City
Zagreb
ZIP/Postal Code
HR-10090
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #191-004
City
Zagreb
ZIP/Postal Code
HRV-10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Gyöngyös
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #1
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #2
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #348-004
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #484-008
City
Merida
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Research Site # 484-004
City
Mexico City
ZIP/Postal Code
7000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #484-006
City
Monterrey
ZIP/Postal Code
64310
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #484-005
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Research Site # 484-003
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #484-010
City
Saltillo
ZIP/Postal Code
25020
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Research Site # 484-002
City
Sinaloa
ZIP/Postal Code
80020
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #484-009
City
Tlalnepantla
ZIP/Postal Code
54055
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site #528-001
City
Amsterdam
ZIP/Postal Code
1081GN
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #703-009
City
Dubnica Nad Váhom
State/Province
Bratislavský Kraj
ZIP/Postal Code
01851
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Rimavska Sobota
State/Province
Sobota
ZIP/Postal Code
97901
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #703-006
City
Banská Bystrica
ZIP/Postal Code
97404
Country
Slovakia
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #703-005
City
Košice
ZIP/Postal Code
04001
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Trencin
ZIP/Postal Code
91108
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Vranov Nad Topľou
ZIP/Postal Code
09301
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Begunje na Gorenjskem
ZIP/Postal Code
4275
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Ljubljana
ZIP/Postal Code
1260
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #705-005
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #705-001
City
Nova Gorica
ZIP/Postal Code
52905000
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #724-010
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Research Site # 724-007
City
Coslada
ZIP/Postal Code
28882
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Madrid
ZIP/Postal Code
28049
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Sant Cugat del Vallès
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Terrassa
ZIP/Postal Code
08222
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

Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

We'll reach out to this number within 24 hrs