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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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ClinicalTrials.gov Identifier: NCT03594123
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Tracking Information
First Submitted Date  ICMJE July 11, 2018
First Posted Date  ICMJE July 20, 2018
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE October 12, 2018
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
Adverse Events (AEs) [ Time Frame: Up to 16 weeks ]
Frequency and severity of AEs will be reviewed to determine safety and tolerability of brexpiprazole
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03594123 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: Brexpiprazole
    2 mg tablet
  • Drug: Brexpiprazole
    3 mg tablet
Study Arms  ICMJE
  • Experimental: Brexpiprazole Arm 1
    Oral tablet; taken once daily. Total daily dose of 2 mg/day
    Intervention: Drug: Brexpiprazole
  • Experimental: Brexpiprazole Arm 2
    Oral tablet; taken once daily. Total daily dose of 3 mg/day
    Intervention: Drug: Brexpiprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2018)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must complete 12 weeks of prior treatment 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 91 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Otsuka Call Center 844-687-8522 OtsukaRMReconciliation@rmpdc.org
Listed Location Countries  ICMJE United States
Removed Location Countries Bulgaria,   Serbia,   Spain,   Ukraine
 
Administrative Information
NCT Number  ICMJE NCT03594123
Other Study ID Numbers  ICMJE 331-201-00182
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE H. Lundbeck A/S
Investigators  ICMJE Not Provided
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP