Back to resultsA 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brexpiprazole
Brexpiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Agitation
Eligibility Criteria
Inclusion Criteria:
- Subject must have participated in the 331-14-213 study.
- Subject must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the subject's symptoms and can observe subject behavior.
Exclusion Criteria:
- Subjects with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.
Sites / Locations
- For additional information regarding sites, contact 844-687-8522
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Brexpiprazole Arm 1
Brexpiprazole Arm 2
Arm Description
Oral tablet; taken once daily. Total daily dose of 2 mg/day
Oral tablet; taken once daily. Total daily dose of 3 mg/day
Outcomes
Primary Outcome Measures
Adverse Events (AEs)
Frequency and severity of AEs will be reviewed to determine safety and tolerability of brexpiprazole
Secondary Outcome Measures
Full Information
NCT ID
NCT03594123
First Posted
July 11, 2018
Last Updated
November 14, 2022
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT03594123
Brief Title
A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Official Title
A 12-week, Multicenter, Active-treatment Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2018 (Actual)
Primary Completion Date
September 19, 2022 (Actual)
Study Completion Date
September 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
H. Lundbeck A/S
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
Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult subjects with agitation associated with dementia of the Alzheimer's type (AAD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Agitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
259 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brexpiprazole Arm 1
Arm Type
Experimental
Arm Description
Oral tablet; taken once daily. Total daily dose of 2 mg/day
Arm Title
Brexpiprazole Arm 2
Arm Type
Experimental
Arm Description
Oral tablet; taken once daily. Total daily dose of 3 mg/day
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Intervention Description
2 mg tablet
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Intervention Description
3 mg tablet
Primary Outcome Measure Information:
Title
Adverse Events (AEs)
Description
Frequency and severity of AEs will be reviewed to determine safety and tolerability of brexpiprazole
Time Frame
Up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
91 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must have participated in the 331-14-213 study.
Subject must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the subject's symptoms and can observe subject behavior.
Exclusion Criteria:
Subjects with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.
Facility Information:
Facility Name
For additional information regarding sites, contact 844-687-8522
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
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
A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
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