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NCT01922258 · ClinicalTrials.gov registry record · Phase 3

Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

A Phase 3 study of Alzheimers Disease and Nervous System Diseases, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 3
Development phase
270
Enrollment target
20
Study locations

NCT01922258 is a Phase 3 study of Alzheimers Disease and Nervous System Diseases that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 270 participants, below the 4,059-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT01922258, a Phase 3 study of Alzheimers Disease and Nervous System Diseases, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
270 participants
Enrollment target
20
Study locations

Study Summary

To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type

Conditions Studied

Alzheimers Disease Nervous System Diseases Mental Disorder Alzheimer's Type Agitation Associated With

Interventions

  • DRUG Brexpiprazole, OPC-34712

Study Locations (20)

California

  • - Imperial
  • - Lakewood
  • - Long Beach
  • - Long Beach
  • - Panorama City
  • - Universal City

Florida

  • - Bradenton
  • - Miami
  • - Miami
  • - Miami
  • - Orange City

Georgia

  • - Atlanta
  • - Smyrna

Massachusetts

  • - Quincy
  • - South Dartmouth

Colorado

  • - Denver

Hawaii

  • - Honolulu

Indiana

  • - Indianapolis

Michigan

  • - Ann Arbor

Trial Details

FieldValue
Enrollment Target 270 participants
Start Date 2013-09
Est. Completion 2017-03
Phase Phase 3

Sponsor

Otsuka Pharmaceutical Development & Commercialization

221 total trials

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What the Registry Record Tells You About NCT01922258

The ClinicalTrials.gov registry entry for NCT01922258 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 270 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,059-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (93% lower). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Alzheimers Disease appearing as the primary indexed condition, and to 1 intervention - of which Brexpiprazole, OPC-34712 is the first listed.

NCT01922258 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT01922258 about?

NCT01922258 is a clinical study titled "Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type". To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type

What is the current status of trial NCT01922258?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2013-09. Estimated completion is 2017-03.

What conditions does trial NCT01922258 study?

This clinical trial studies the following conditions: Alzheimers Disease, Nervous System Diseases, Mental Disorder, Alzheimer's Type, Agitation Associated With.

What interventions are being tested in trial NCT01922258?

The interventions under investigation include: Brexpiprazole, OPC-34712 (DRUG).

Who is sponsoring clinical trial NCT01922258?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01922258 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.