Safety Follow-up Study for Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Previously Participated in a Double-blind Trial of Brexpiprazole or Placebo
NCT ID: NCT02192554
Last Updated: 2018-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
450 participants
OBSERVATIONAL
2014-06-30
2017-05-31
Brief Summary
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Detailed Description
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This is a trial designed to assess the ongoing safety of subjects with agitation associated with dementia of the Alzheimer's type after completing a 12-week double-blind trial of brexpiprazole or placebo; drug and placebo are discontinued prior to subjects enrolling in the safety follow-up trial. The trial consists of a continuous 2 month observation period. The trial population will include male and female subjects with a diagnosis of probable Alzheimer's disease.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Male and female subjects who completed both the 12-week double-blind treatment period and the 30-day safety follow-up visit of the previous brexpiprazole trial.
* Subject has an identified caregiver who is usually assigned to care for the subject on a regular basis, has sufficient contact to describe the subject's symptoms, and has direct observation of the subject's behavior.
* Subject is able to comply with the protocol requirements.
Exclusion Criterion:
* Subjects who, in the opinion of the investigator, medical monitor, or sponsor should not participate in the trial.
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eva Kohegyi, MD, MS
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Development & Commercialization, Inc.
Locations
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Tuscaloosa, Alabama, United States
Costa Mesa, California, United States
Lakewood, California, United States
Orange, California, United States
Redlands, California, United States
Bradenton, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Springs, Florida, United States
North Miami, Florida, United States
Orange City, Florida, United States
Sarasota, Florida, United States
Atlanta, Georgia, United States
Suwanee, Georgia, United States
Quincy, Massachusetts, United States
St Louis, Missouri, United States
Toms River, New Jersey, United States
Brooklyn, New York, United States
New Hyde Park, New York, United States
Charlotte, North Carolina, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Dallas, Texas, United States
Waukesha, Wisconsin, United States
Burgas, , Bulgaria
Kardzhali, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Veliko Tarnovo, , Bulgaria
Penticton, British Columbia, Canada
Kentville, Nova Scotia, Canada
Zagreb, , Croatia
Zagreb, , Croatia
Bourg N Bresse, , France
Douai, , France
Élancourt, , France
Toulouse, , France
Mittweida, Saxony, Germany
Berlin, , Germany
Bochum, , Germany
Cologne, , Germany
Westerstede, , Germany
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Saratov, , Russia
Tonnelniy, , Russia
Yekaterinburg, , Russia
Belgrade, , Serbia
Kovin, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Novi Kneževac, , Serbia
Novi Sad, , Serbia
Ljubljana, , Slovenia
Maribor, , Slovenia
Šempeter pri Gorici, , Slovenia
Pamplona, , Spain
Salamanca, , Spain
Valencia, , Spain
Valencia, , Spain
Zamora, , Spain
Kharkiv, , Ukraine
Kherson, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Odesa, , Ukraine
Poltava, , Ukraine
Vinnytsia, , Ukraine
Torpoint, , United Kingdom
Countries
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Other Identifiers
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331-13-211
Identifier Type: -
Identifier Source: org_study_id
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