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

Completed

Conditions studied: Agitation Associated With Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases

In brief

To follow-up on the safety of subjects who were previously treated in a double-blind trial of brexpiprazole.

Key facts

Study ID

NCT02192554

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

450

Starts

2014-06-01

Expected to finish

2017-05-01

Last updated by the study team

2018-04-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The investigator must assess the capacity of the subject to provide informed consent prior to enrollment and throughout the trial.
• 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.

Where it is running

• Study site — Costa Mesa, California, United States
• Study site — Lakewood, California, United States
• Study site — Orange, California, United States
• Study site — Redlands, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Springs, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Orange City, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Suwanee, Georgia, United States
• Study site — Quincy, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Toms River, New Jersey, United States
• Study site — Brooklyn, New York, United States
• Study site — New Hyde Park, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Hickory, North Carolina, United States
• Study site — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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