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NCT03594123 · ClinicalTrials.gov registry record · Phase 3

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

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

Completed
Registry status
Phase 3
Development phase
259
Enrollment target
1
Study location

NCT03594123 is a Phase 3 study of Alzheimers Disease that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 259 participants, below the 4,060-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03594123, a Phase 3 study of Alzheimers Disease, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
259 participants
Enrollment target
1
Study location

Study 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 participants with agitation associated with dementia of the Alzheimer's type (AAD).

Conditions Studied

Interventions

  • DRUG Brexpiprazole

Study Locations (1)

Florida

  • For additional information regarding sites, contact 844-687-8522 - Miami

Trial Details

FieldValue
Enrollment Target 259 participants
Start Date 2018-10-11
Est. Completion 2022-09-19
Phase Phase 3

What the Registry Record Tells You About NCT03594123

The ClinicalTrials.gov registry entry for NCT03594123 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 259 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,060-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (94% lower). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

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

NCT03594123 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT03594123 about?

NCT03594123 is a clinical study titled "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". 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 participants with agitation associated with dementia of the Alzheimer's type (AAD).

What is the current status of trial NCT03594123?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 259 participants. The study started on 2018-10-11. Estimated completion is 2022-09-19.

What conditions does trial NCT03594123 study?

This clinical trial studies the following conditions: Alzheimers Disease.

What interventions are being tested in trial NCT03594123?

The interventions under investigation include: Brexpiprazole (DRUG).

Who is sponsoring clinical trial NCT03594123?

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

Where is trial NCT03594123 being conducted?

This trial has 1 study location across Florida. 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

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