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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03594123
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : April 23, 2019
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT03594123

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United States, Florida
Advanced Clinical Research Recruiting
Coral Gables, Florida, United States, 33134
Contact: Gil Fernandez-Yera    305-702-1594   
Research in Miami, Inc. Recruiting
Hialeah, Florida, United States, 33013
Contact: Dolores Sanchez-Cazau, M.D.    305-889-6670   
Galiz Research, LLC Recruiting
Hialeah, Florida, United States, 33016
Contact: Jose Gamez, M.D.    305-805-0921   
SIH Research Recruiting
Kissimmee, Florida, United States, 34741
Contact: Syed Mumtaz    407-932-1977   
Arocha Research Center Recruiting
Miami, Florida, United States, 33145
Contact: Emelina Arocha    786-587-9425   
Allied Biomedical Research Institute Recruiting
Miami, Florida, United States, 33155
Contact: Michael Pfeffer    305-702-1594   
IMIC Inc Recruiting
Palmetto Bay, Florida, United States, 33157
Contact: Evelyn Lopez-Brigoni    768-310-7477   
United States, Massachusetts
Alzheimer Disease Center Recruiting
Winchester, Massachusetts, United States, 01890
Contact: Anil Nair    617-639-5006   
United States, New Jersey
Bio Behavioral Health Recruiting
Toms River, New Jersey, United States, 08755
Contact: Ashok Patel    732-244-2299   
United States, New York
Integrative Clinical Trials LLC Recruiting
Brooklyn, New York, United States, 11229
Contact: Inna Yuryev-Golger    718-444-7774   
Mental Health Center Prof. Dr Ivan Temkov - Burgas EOOD Recruiting
Burgas, Bulgaria, 8000
Contact: Veselin Palazov    359-56816298   
Medical Center Intermedica OOD Recruiting
Sofia, Bulgaria, 1680
Contact: Toni Donchev    359895556767   
Diagnostic and Consultative Centre Mladost - M Varna OOD Recruiting
Varna, Bulgaria, 9020
Contact: Petar Petrov    359 888 940142   
Mental Health Center - Vratsa EOOD Recruiting
Vratsa, Bulgaria, 3000
Contact: Nadya Ivanova    359-887-422-440   
Complejo Asistencial de Zamora. Servicio de Psiquiatria Recruiting
Zamora, Spain, 49021
Contact: Manuel Franco Martin    34 651 573 536   
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   
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   
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   
Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital", Department #20 Recruiting
Lviv, Ukraine, 79021
Contact: Kateryna Zakal    380 677672919   
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   
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier: NCT03594123     History of Changes
Other Study ID Numbers: 331-201-00182
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 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.:

Additional relevant MeSH terms:
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Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
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