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NCT04276883 · ClinicalTrials.gov registry record · Phase 3

Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder

A Phase 3 study of Bipolar Disorder and Agitation,Psychomotor, sponsored by BioXcel Therapeutics.

Completed
Registry status
Phase 3
Development phase
380
Enrollment target
15
Study locations

NCT04276883 is a Phase 3 study of Bipolar Disorder and Agitation,Psychomotor that has completed, run by BioXcel Therapeutics. The registered enrollment target is 380 participants, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (15% higher). The trial reports 15 study locations across 9 states.

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The verdict

NCT04276883, a Phase 3 study of Bipolar Disorder and Agitation,Psychomotor, has completed, sponsored by BioXcel Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
380 participants
Enrollment target
15
Study locations

Study Summary

This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder. The BXCL501-302 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with bipolar disorder.

Conditions Studied

Bipolar Disorder Agitation,Psychomotor Agitation Associated With Bipolar Disorder

Interventions

  • DRUG Placebo Film
  • DRUG Sublingual film containing Dexmedetomidine (BXCL501)

Study Locations (15)

California

  • BioXcel Clinical Research Site - Cerritos
  • BioXcel Clinical Research Site - Culver City
  • BioXcel Clinical Research Site - Long Beach
  • BioXcel Clinical Research Site - Orange

Texas

  • BioXcel Clinical Research Site - Austin
  • BioXcel Clinical Research Site - DeSoto
  • BioXcel Clinical Research Site - Richardson

New Jersey

  • BioXcel Clinical Research Site - Berlin
  • BioXcel Clinical Research Site - Marlton

Arkansas

  • BioXcel Clinical Research Site - Little Rock

Florida

  • BioXcel Clinical Research Site - Miami Lakes

Illinois

  • BioXcel Clinical Research Site - Chicago

Maryland

  • BioXcel Clinical Research Site - Gaithersburg

Nevada

  • BioXcel Clinical Research Site - Las Vegas

Trial Details

FieldValue
Enrollment Target 380 participants
Start Date 2020-02-24
Est. Completion 2020-05-21
Phase Phase 3

Sponsor

BioXcel Therapeutics

13 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04276883

The ClinicalTrials.gov registry entry for NCT04276883 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 380 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (15% higher). The listed sponsor is BioXcel Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo Film is the first listed.

NCT04276883 reports 15 study locations spanning 9 distinct geographic areas - top geographies include California, Texas, New Jersey.

Frequently Asked Questions

What is clinical trial NCT04276883 about?

NCT04276883 is a clinical study titled "Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder". This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder. The BXCL501-302 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation asso...

What is the current status of trial NCT04276883?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2020-02-24. Estimated completion is 2020-05-21.

What conditions does trial NCT04276883 study?

This clinical trial studies the following conditions: Bipolar Disorder, Agitation,Psychomotor, Agitation Associated With Bipolar Disorder.

What interventions are being tested in trial NCT04276883?

The interventions under investigation include: Placebo Film (DRUG), Sublingual film containing Dexmedetomidine (BXCL501) (DRUG).

Who is sponsoring clinical trial NCT04276883?

This trial is sponsored by BioXcel Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04276883 being conducted?

This trial has 15 study locations across Arkansas, California, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.