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Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder

NCT04276883 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2023-09-11

Study results available
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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

  • Agitation Associated With Bipolar Disorder
  • Agitation,Psychomotor
  • Bipolar Disorder

Interventions

DRUG

Sublingual film containing Dexmedetomidine (BXCL501)

Sublingual film containing Dexmedetomidine (BXCL501)

DRUG

Placebo Film

Placebo Film for BXCL501

Sponsors & Collaborators

  • Cognitive Research Corporation

    collaborator INDUSTRY

  • BioXcel Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2020-05-21
Completion
2020-05-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04276883 on ClinicalTrials.gov