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Trial record 16 of 65 for:    Brexpiprazole

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 : July 17, 2019
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

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).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Brexpiprazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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 Alzheimer's Type
Actual Study Start Date : October 12, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
Experimental: Brexpiprazole Arm 1
Oral tablet; taken once daily. Total daily dose of 2 mg/day
Drug: Brexpiprazole
2 mg tablet

Experimental: Brexpiprazole Arm 2
Oral tablet; taken once daily. Total daily dose of 3 mg/day
Drug: Brexpiprazole
3 mg tablet




Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Up to 16 weeks ]
    Frequency and severity of AEs will be reviewed to determine safety and tolerability of brexpiprazole



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 91 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594123


Locations
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United States, California
Shreenath Clinical Service Recruiting
Lakewood, California, United States, 90805
Contact: Gnyandev Patel    714-964-7852    GPATELRESEARCH@AOL.COM   
United States, Florida
Advanced Clinical Research Recruiting
Coral Gables, Florida, United States, 33134
Contact: Gil Fernandez-Yera    305-702-1594    gilfyeramd@acrntrials.com   
Research in Miami, Inc. Recruiting
Hialeah, Florida, United States, 33013
Contact: Dolores Sanchez-Cazau, M.D.    305-889-6670    dcazau@researchinmiami.com   
Galiz Research, LLC Recruiting
Hialeah, Florida, United States, 33016
Contact: Jose Gamez, M.D.    305-805-0921    jegamez@galizresearch.com   
SIH Research Recruiting
Kissimmee, Florida, United States, 34741
Contact: Syed Mumtaz    407-932-1977    syed.mumtaz@sihresearch.org   
Arocha Research Center Recruiting
Miami, Florida, United States, 33145
Contact: Emelina Arocha    786-587-9425    emelinaarochamd@gmail.com   
Allied Biomedical Research Institute Recruiting
Miami, Florida, United States, 33155
Contact: Michael Pfeffer    305-702-1594    mpfeffer@abriusa.net   
IMIC Inc Recruiting
Palmetto Bay, Florida, United States, 33157
Contact: Evelyn Lopez-Brigoni    768-310-7477    evelyn@aktamedika.com   
United States, Massachusetts
Alzheimer Disease Center Recruiting
Winchester, Massachusetts, United States, 01890
Contact: Anil Nair    617-639-5006    nair.anil@gmail.com   
United States, New Jersey
Bio Behavioral Health Recruiting
Toms River, New Jersey, United States, 08755
Contact: Ashok Patel    732-244-2299    ap@bbhnj.com   
United States, New York
Integrative Clinical Trials LLC Recruiting
Brooklyn, New York, United States, 11229
Contact: Inna Yuryev-Golger    718-444-7774    igolger@iclinicaltrials.net   
Bulgaria
Mental Health Center Prof. Dr Ivan Temkov - Burgas EOOD Recruiting
Burgas, Bulgaria, 8000
Contact: Veselin Palazov    359-56816298    vpalazov@abv.bg   
Mental Health Centre-Ruse EOOD, Daily Unit Recruiting
Ruse, Bulgaria, 7003
Contact: Temenuzhka Dechkova-Novakova    359-878435010    mateva_rs@mail.bg   
Medical Center Intermedica OOD Recruiting
Sofia, Bulgaria, 1680
Contact: Toni Donchev    359895556767    tonyd@abv.bg   
Diagnostic and Consultative Centre Mladost - M Varna OOD Recruiting
Varna, Bulgaria, 9020
Contact: Petar Petrov    359 888 940142    pmdown@abv.bg   
Diagnostic and Consultative Centre Mladost - M Varna OOD Recruiting
Varna, Bulgaria, 9020
Contact: Hristo Kozhuharov    359-888816035    christokojuharov@abv.bg   
Mental Health Center - Vratsa EOOD Recruiting
Vratsa, Bulgaria, 3000
Contact: Nadya Ivanova    359-887-422-440    nadia_odpzs@abv.bg   
Serbia
Clinical Hospital Center "Dr. Dragisa Misovic - Dedinje" Recruiting
Belgrade, Serbia, 11000
Contact: Vladimir Diligenski    381-112661002    dilig@eunet.rs   
Special Hospital for Psychiatric Diseases "Kovin" Recruiting
Kovin, Serbia, 26220
Contact: Jovanka Petrovic    381-13741166    petrovicjoka@yahoo.com   
Spain
Centro de Salud San Juan Recruiting
Salamanca, Spain, 37005
Contact: Angel Luis Montejo-Gonzalez    34-923205454    amontejo@usal.es   
Complejo Asistencial de Zamora. Servicio de Psiquiatria Recruiting
Zamora, Spain, 49021
Contact: Manuel Franco Martin    34 651 573 536    mfm@intras.es   
Ukraine
Public Non-profit Enterprise within Kharkiv Regional Council "Regional Clinical Psychiatric Hospital No. 3, #14 psychiatric department for adults Recruiting
Kharkiv, Ukraine, 61068
Contact: Valentyna Kozidubova    380-0954735838    valentinakozidubova@gmail.com   
Public Non-profit Enterprise within Kharkiv Regional Council "Regional Clinical Psychiatric Hospital No. 3, #23 psychiatric department for war veterans Recruiting
Kharkiv, Ukraine, 61068
Contact: Andriy Dubenko    380-503002321    adneuro1801@gmail.com   
Public Institution: Kherson Regional Psychiatric Hospital within Kherson Regional Council, Male Psychiatric Department #3 and Female Psychiatric Department #10 Recruiting
Kherson, Ukraine, 73488
Contact: Pavlo Palamarchuk    380-504940457    pavel.palamarchuk@mental.kherson.ua   
Kyiv Regional Medical Incorporation "Psychiatry", Center for Novel Treatment and Rehabilitation of Phychotic disorders, Department 29 (Men's), Department 30 (Women's), Outpatient Clinic Office of Department 30 Recruiting
Kyiv, Ukraine, 4080
Contact: Yuliya Blazhevych    38050-384-70-48    blazhevych@ukr.net   
Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital", Department #20 Recruiting
Lviv, Ukraine, 79021
Contact: Kateryna Zakal    380 677672919    katerynaz97@gmail.com   
Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev,7 department (gerontopsychiatric, palliative care), Higher State Educational Establishment of Ukraine "Ukrainian Medical and Dental Academy", Chair of Psychiatry, Narcology and Medica Recruiting
Poltava, Ukraine, 36013
Contact: Andrii Skrypnikov    380 50 252 33 00    skripnikovan@mail.ru   
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03594123     History of Changes
Other Study ID Numbers: 331-201-00182
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Agitation
Additional relevant MeSH terms:
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Brexpiprazole
Alzheimer Disease
Dementia
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents