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    Summary
    EudraCT Number:2014-000424-23
    Sponsor's Protocol Code Number:331-13-211
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2014-000424-23
    A.3Full title of the trial
    A 2-month, Observational, Rollover Trial to Evaluate the Safety of Subjects with Agitation Associated with Dementia of the Alzheimer’s Type who were Previously Treated with Brexpiprazole (OPC-34712) or Placebo in a Phase 3, Double-blind Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Observational Trial to Evaluate the Safety of Subjects with Agitation Associated with Dementia of the Alzheimer’s Type who were Previously Treated with Brexpiprazole or Placebo
    A.4.1Sponsor's protocol code number331-13-211
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.5.2Functional name of contact pointLaura Beth Duncan
    B.5.3 Address:
    B.5.3.1Street Address2440 Research Blvd.
    B.5.3.2Town/ cityRockville, MD
    B.5.3.3Post code20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1240780 4286
    B.5.5Fax number+1240399 6286
    B.5.6E-mailLaurabeth.Duncan@otsuka-us.com
    D. IMP Identification
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Agitation Associated with Dementia of the Alzheimer's Type
    E.1.1.1Medical condition in easily understood language
    Dementia of the Alzheimer's Type
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety of subjects with agitation associated
    with dementia of the Alzheimer’s type who were previously
    treated with brexpiprazole (0.5, 1, or 2 mg/day) or placebo
    during Trial 331-12-283 or Trial 331-12-284
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The investigator must assess the capacity of the subject to provide informed consent prior to enrollment and throughout the course of the trial. Once this determination is made by the investigator, the options for obtaining informed consent from and/or on behalf of the subject must be followed accordingly:

    - If the subject is deemed capable by the investigator, written informed consent will be obtained from the subject prior to the initiation of any trial protocol-required procedures. In such cases, acknowledgement from the subject’s legally acceptable representative (an individual, or judicial or other body, authorized under applicable law to consent to the
    subject’s participation in the clinical trial on behalf of that prospective subject) will also be obtained, if required, in accordance with state and/or local regulations prior to initiation of any trial protocol-required procedures.

    - If the subject is deemed incapable by the investigator of providing consent (eg, subjects with severe dementia), written informed consent will be obtained from the subject’s legally acceptable representative prior to initiation of any trial protocol-required procedures. In such cases, assent from the subject, if possible, will be confirmed in accordance with state and/or local regulations prior to the initiation of any trial protocol-required procedures.

    - If the subject cannot provide assent, and does not dissent, then the consent of the legally acceptable representative is sufficient unless otherwise required by the governing ethics body and/or applicable state and/or local regulations.

    - If the subject dissents, then the subject is not eligible for participation in the trial.

    - If the subject initially provided assent at trial entry, but subsequently dissents to participate in the trial, then the subject will be early terminated from the trial.

    - If the subject was initially deemed capable of providing informed consent but is no longer deemed so, informed consent must be obtained from the subject’s legally acceptable representative, and assent from the subject, if possible, will be confirmed in accordance with state and/or local regulations prior to the initiation of any trial protocol-required procedures.

    - Male and female subjects who completed all the visits of the double-blind treatment period and the 30-day safety follow-up visit of a previous phase 3 brexpiprazole trial of
    subjects with agitation associated with dementia of the Alzheimer’s type.

    - Institutionalized subjects with an identified caregiver who has sufficient contact to describe the subject’s symptoms and has direct observation of the subject’s behavior. The
    identified caregiver can be a staff member of the institutionalized setting or another individual (eg, family member, family friend, hired professional caregiver) who meets the caregiver requirements.

    - Non-institutionalized subjects may not be living alone and must have an identified caregiver who has sufficient contact to describe the subject’s symptoms and has direct
    observation of the subject’s behavior.

    - Subjects able to satisfactorily comply with the protocol
    requirements.
    E.4Principal exclusion criteria
    Key exclusion criteria include the following:
    - Subjects who, in the opinion of the investigator, medical monitor, or sponsor should not participate in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    The following safety endpoints will be evaluated during this trial.
    - Frequency and severity of AEs, serious AEs, and discontinuations from the trial due to AEs.
    - Frequency and severity of AEs related to the worsening of agitation associated with Alzheimer’s disease.
    - Frequency and severity of AEs related to the worsening of cognition associated with Alzheimer’s disease.
    - Frequency and severity of other AEs of interest (eg, falls, sedation, weight changes, or deaths).
    - Newly initiated concomitant medications for the treatment of agitation associated with Alzheimer’s disease.
    - Newly initiated concomitant medications for the treatment of cognitive symptoms associated with Alzheimer’s disease.
    - Mean change in the MMSE score from baseline (Week 12 MMSE from Trials 283/284) to Month 2/ET.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Observational rollover trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Canada
    Croatia
    France
    Germany
    Russian Federation
    Serbia
    Slovenia
    Spain
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The End of Trial Date is defined as the date for the Month 2/ET visit, or the last Date of Contact or the Date of Final Contact Attempt if the Month 2/ET visit does not occur as a clinic visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 336
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The trial population will consist of male and female subjects who completed both the 12-week double-blind treatment period and the 30-day safety follow-up visit of Trials 283/284.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 400
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-30
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