NCT03724942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

November 9, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2022

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

May 1, 2024

Enrollment Period

3.1 years

First QC Date

October 28, 2018

Results QC Date

November 5, 2023

Last Update Submit

May 9, 2024

Conditions

Agitation Associated With Dementia of the Alzheimer's Type

Outcome Measures

Primary Outcomes (1)

  • The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs)

    This trial enrolled subjects rolled over from Trial 331-102-00088, and the safety of brexpiprazole when administered for a maximum of 24 weeks (including the treatment period of Trial 331-102-00088) was evaluated.

    From baseline to week 14

Secondary Outcomes (3)

  • Mean Change From Baseline in Cohen-Mansfield Agitation Inventory (CMAI) Score at 14 Weeks After Dosing

    Baseline and 14 weeks after dosing

  • Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 14 Weeks After Dosing.

    Baseline and 14 weeks after dosing.

  • Clinical Global Impression of Improvement (CGI-I) Score at 14 Weeks After Dosing

    14 weeks after dosing.

Study Arms (1)

Brexpiprazole

EXPERIMENTAL
Drug: Brexpiprazole

Interventions

BrexpiprazoleDRUG

Brexpiprazole 1mg or 2mg will be orally once daily for 14 weeks

Also known as: OPC-34712
Brexpiprazole

Eligibility Criteria

Age55 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jisenkai Nanko Psychiatric Institute

Shirakawa, Japan

Location

Related Publications (1)

  • Nakamura Y, Adachi J, Hirota N, Iba K, Shimizu K, Nakai M, Mori N, Takahashi K. Long-term safety and tolerability of brexpiprazole for Japanese patients with agitation in Alzheimer's disease dementia: A multicenter, open-label study. J Alzheimers Dis Rep. 2025 Apr 16;9:25424823251334054. doi: 10.1177/25424823251334054. eCollection 2025 Jan-Dec.

    PMID: 40290781DERIVED

MeSH Terms

Interventions

brexpiprazole

Results Point of Contact

Title
Director of Clinical Trials
Organization
Otsuka Pharmaceutical Co., Ltd.
CL_OPCJ_RDA_Team@otsuka.jp
+81363617366

Study Officials

  • Osamu Sato

    Otsuka Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2018

First Posted

October 30, 2018

Study Start

November 9, 2018

Primary Completion

December 2, 2021

Study Completion

January 5, 2022

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

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.

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.
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.

Locations

JP(1)