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COMPLETED Phase 3

Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder

NCT04276883 · View on ClinicalTrials.gov ↗

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.

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

4 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 380 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioXcel Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04276883 reports 15 study locations spanning 9 distinct geographic areas — top geographies include California, Texas, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04276883?

The interventions under investigation include: Placebo Film (DRUG), Sublingual film containing Dexmedetomidine (BXCL501) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04276883?

This trial is sponsored by BioXcel Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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