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

Sponsor ID
331-201-00182
Clinicaltrials.gov ID
NCT03594123
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
331-201-00182
Trial Details
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Age
55 - 91 Years
Therapeutic Area
  • Dementia/Alzheimer
    • Sex
    Female & Male
    Trial Dates
    Oct 2018 - Sep 2022
    Healthy Volunteers
    No
    • Participants must have participated in the 331-14-213 study.
    • Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior.
    • Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.

    Study 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 participants with agitation associated with dementia of the Alzheimer's type (AAD).

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: Brexpiprazole
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    259
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Participants must have participated in the 331-14-213 study.
    • * Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior.

    Exclusion Criteria

    • * Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Participants must have participated in the 331-14-213 study.
    • Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior.
    Exclusion Criteria:
    • Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    Locations

    Location
    Status
    Location
    For additional information regarding sites, contact 844-687-8522
    Miami, Florida, United States, 33155
    Status
    N/A

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