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Clinical trials for Dementia, Alzheimer Type AND Dementia AND Brexpiprazole, OPC-34712

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44352   clinical trials with a EudraCT protocol, of which   7379   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    5 result(s) found for: Dementia, Alzheimer Type AND Dementia AND Brexpiprazole, OPC-34712. Displaying page 1 of 1.
    EudraCT Number: 2013-000503-17 Sponsor Protocol Number: 331-12-284 Start Date*: 2015-01-29
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Flexible Dosing of Brexpiprazole (OPC-34712) in the Treatme...
    Medical condition: Agitation Associated with Dementia of the Alzheimer’s Type
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FI (Prematurely Ended) SI (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2018-002783-88 Sponsor Protocol Number: 331-201-00182 Start Date*: 2018-12-27
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: 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 Alzheim...
    Medical condition: Agitation Associated With Dementia of the Alzheimer's Type
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) ES (Ongoing) HU (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2013-000504-41 Sponsor Protocol Number: 331-12-283 Start Date*: 2013-12-10
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: Country-specific protocol amendment for Germany entitled: A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2...
    Medical condition: Agitation Associated with Dementia of the Alzheimer’s Type
    Disease: Version SOC Term Classification Code Term Level
    19.1 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2017-003940-19 Sponsor Protocol Number: 331-14-213 Start Date*: 2018-08-06
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo controlled, 2 Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatme...
    Medical condition: Agitation Associated With Dementia of the Alzheimer’s Type
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) ES (Ongoing) HU (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2014-000424-23 Sponsor Protocol Number: 331-13-211 Start Date*: 2014-10-31
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: 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...
    Medical condition: Agitation Associated with Dementia of the Alzheimer's Type
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) SI (Completed) FR (Completed) GB (Completed) HR (Completed) BG (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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