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

April 27, 2018 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A 2-Month, Observational, Rollover Trial to Evaluate the Safety of Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Were Previously Treated With Brexpiprazole (OPC 34712) or Placebo in a Phase 3, Double-blind Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Behavioral symptoms, such as agitation, are core features in subjects with Alzheimer's disease and related dementias, and develop in the majority of dementia subjects. The presence of agitation in subjects with Alzheimer's disease places a significant burden not only on subjects and their caregivers but also on the healthcare system.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
      • Kardzhali, Bulgaria, 6600
      • Ruse, Bulgaria, 7003
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1113
      • Varna, Bulgaria, 9020
      • Veliko Tŭrnovo, Bulgaria, 5000
  • Canada
    • British Columbia
      • Penticton, British Columbia, Canada, V2A 4M4
    • Nova Scotia
      • Kentville, Nova Scotia, Canada, B4N 4K9
  • Croatia
      • Zagreb, Croatia, 10000
      • Zagreb, Croatia, 10090
  • France
      • Bourg N Bresse, France, 01012
      • Douai, France, 59500
      • Elancourt, France, 78990
      • Toulouse, France, 31059
  • Germany
      • Berlin, Germany, 12209
      • Bochum, Germany, 44791
      • Koln, Germany, 50935
      • Westerstede, Germany, 26655
    • Saxony
      • Mittweida, Saxony, Germany, 9648
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620030
      • Samara, Russian Federation, 443016
      • Saratov, Russian Federation, 410060
      • St. Petersburg, Russian Federation, 192019
      • St. Petersburg, Russian Federation, 197341
      • St. Petersburg, Russian Federation, 190000
      • St. Petersburg, Russian Federation, 190005
      • St. Petersburg, Russian Federation, 191119
      • St. Petersburg, Russian Federation, 198510
      • St. Petersburg, Russian Federation, 191040
      • St. Petersburg, Russian Federation, 195176
      • Tonnelniy, Russian Federation, 357034
  • Serbia
      • Belgrade, Serbia, 11000
      • Kovin, Serbia, 26220
      • Kragujevac, Serbia, 34000
      • Niš, Serbia, 18000
      • Novi Knezevac, Serbia, 23330
      • Novi Sad, Serbia, 21000
  • Slovenia
      • Ljubljana, Slovenia, 1000
      • Maribor, Slovenia, 2000
      • Sempeter pri Gorici, Slovenia, 5290
  • Spain
      • Pamplona, Spain, 31014
      • Salamanca, Spain, 37004
      • Valencia, Spain, 46026
      • Valencia, Spain, 46010
      • Zamora, Spain, 49021
  • Ukraine
      • Kharkiv, Ukraine, 61068
      • Kherson, Ukraine, 73488
      • Kiev, Ukraine, 04080
      • Kiev, Ukraine, 04114
      • Lviv, Ukraine, 79021
      • Odessa, Ukraine, 67513
      • Odessa, Ukraine, 35006
      • Poltava, Ukraine, 36013
      • Vinnytsia, Ukraine, 21005
  • United Kingdom
      • Torpoint, United Kingdom, PL11 2TB
  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35404
    • California
      • Costa Mesa, California, United States, 92626
      • Lakewood, California, United States, 90805
      • Orange, California, United States, 92868
      • Redlands, California, United States, 92373
    • Florida
      • Bradenton, Florida, United States, 34205
      • Hialeah, Florida, United States, 33012
      • Hialeah, Florida, United States, 33018
      • Miami, Florida, United States, 33137
      • Miami, Florida, United States, 33126
      • Miami, Florida, United States, 33175
      • Miami, Florida, United States, 33122
      • Miami Springs, Florida, United States, 33166
      • North Miami, Florida, United States, 33161
      • Orange City, Florida, United States, 32763
      • Sarasota, Florida, United States, 34239
    • Georgia
      • Atlanta, Georgia, United States, 30331
      • Suwanee, Georgia, United States, 30024
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
    • Missouri
      • Saint Louis, Missouri, United States, 63128
    • New Jersey
      • Toms River, New Jersey, United States, 08755
    • New York
      • Brooklyn, New York, United States, 11214
      • New Hyde Park, New York, United States, 11040
    • North Carolina
      • Charlotte, North Carolina, United States, 28270
      • Hickory, North Carolina, United States, 28601
      • Raleigh, North Carolina, United States, 27609
    • Texas
      • Dallas, Texas, United States, 75243
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects must have completed a previous double-blind trial of brexpiprazole or placebo; neither drug or placebo will be administered in the trial

Description

Inclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Adverse Events (AEs)
Time Frame: Baseline to Month 2/Early Termination
Baseline to Month 2/Early Termination
Mini-Mental State Examination (MMSE) score
Time Frame: Baseline to Month 2/Early Termination
Baseline to Month 2/Early Termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
H. Lundbeck A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eva Kohegyi, MD, MS, Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 331-13-211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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