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 |
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Recruitment Status :
Recruiting
First Posted : July 20, 2018
Last Update Posted : July 17, 2019
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Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
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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 |
| 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Alzheimer disease
Drug Information available for:
Brexpiprazole
| Arm | Intervention/treatment |
|---|---|
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Experimental: Brexpiprazole Arm 1
Oral tablet; taken once daily. Total daily dose of 2 mg/day
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Drug: Brexpiprazole
2 mg tablet |
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Experimental: Brexpiprazole Arm 2
Oral tablet; taken once daily. Total daily dose of 3 mg/day
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Drug: Brexpiprazole
3 mg tablet |
Primary Outcome Measures :
- 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
| 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
| 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 |
| 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.:
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Agitation |
Additional relevant MeSH terms:
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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 Brexpiprazole Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Dopamine Agonists Dopamine Agents |