Back to resultsBrexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Primary Purpose
Agitation Associated With Dementia of the Alzheimer's Type
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Brexpiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Agitation Associated With Dementia of the Alzheimer's Type
Eligibility Criteria
Inclusion Criteria:
- Patients who completed the double-blind treatment period for 10 weeks and all observation, examination and evaluation at Week 10 of the double-blind trial.
- Patients whose caregiver can properly collect the necessary information.
Exclusion Criteria:
- Patients who had a serious adverse event which the principal investigator or sub-investigator assessed as related to the investigator product during the double-blind trial.
- Patients who had delirium during the double-blind trial.
Sites / Locations
- Jisenkai Nanko Psychiatric Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brexpiprazole
Arm Description
Outcomes
Primary Outcome Measures
The frequency of Adverse events
Secondary Outcome Measures
Mean change from baseline in Cohen-Mansfield Agitation Inventory (CMAI) score at 14 weeks after dosing
Mean change from baseline in Clinical Global Impression of Severity (CGI-S) score at 14 weeks after dosing
Mean change from baseline in Clinical Global Impression of Improvement (CGI-I) score at 14 weeks after dosing
Full Information
NCT ID
NCT03724942
First Posted
October 28, 2018
Last Updated
January 12, 2022
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03724942
Brief Title
Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Official Title
A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Safety of Extended Treatment With Brexpiprazole (OPC-34712) to Patients With Agitation Associated With Dementia of the Alzheimer's Type
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
December 2, 2021 (Actual)
Study Completion Date
January 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy of brexpiprazole.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation Associated With Dementia of the Alzheimer's Type
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brexpiprazole
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Other Intervention Name(s)
OPC-34712
Intervention Description
Brexpiprazole 1mg or 2mg will be orally once daily for 14 weeks
Primary Outcome Measure Information:
Title
The frequency of Adverse events
Time Frame
From baseline to week 14
Secondary Outcome Measure Information:
Title
Mean change from baseline in Cohen-Mansfield Agitation Inventory (CMAI) score at 14 weeks after dosing
Time Frame
Baseline and 14 weeks after dosing
Title
Mean change from baseline in Clinical Global Impression of Severity (CGI-S) score at 14 weeks after dosing
Time Frame
Baseline and 14 weeks after dosing
Title
Mean change from baseline in Clinical Global Impression of Improvement (CGI-I) score at 14 weeks after dosing
Time Frame
Baseline and 14 weeks after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who completed the double-blind treatment period for 10 weeks and all observation, examination and evaluation at Week 10 of the double-blind trial.
Patients whose caregiver can properly collect the necessary information.
Exclusion Criteria:
Patients who had a serious adverse event which the principal investigator or sub-investigator assessed as related to the investigator product during the double-blind trial.
Patients who had delirium during the double-blind trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osamu Sato
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Jisenkai Nanko Psychiatric Institute
City
Shirakawa
Country
Japan
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.
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 an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
Learn more about this trial
Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
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