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Completed Phase 3 Interventional Results available

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia

ClinicalTrials.gov ID: NCT04268303

Public ClinicalTrials.gov record NCT04268303. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 12:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Determine Efficacy and Safety of BXCL501 In Agitation Associated With Schizophrenia

Study identification

NCT ID
NCT04268303
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
BioXcel Therapeutics Inc
Industry
Enrollment
380 participants

Conditions and interventions

Interventions

  • Sublingual film containing dexmedetomidine (BXCL501) Drug
  • Placebo Film Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 23, 2020
Primary completion
May 5, 2020
Completion
May 5, 2020
Last update posted
Jun 3, 2026

2020

United States locations

U.S. sites
15
U.S. states
9
U.S. cities
15
Facility City State ZIP Site status
BioXcel Clinical Research Site Little Rock Arkansas 72211
BioXcel Clinical Research Site Cerritos California 78754
BioXcel Clinical Research Site Culver City California 90230
BioXcel Clinical Research Site Long Beach California 90806
BioXcel Clinical Research Site Orange California 92868
BioXcel Clinical Research Site Miami Lakes Florida 33016
BioXcel Clinical Research Site Chicago Illinois 60640
BioXcel Clinical Research Site Gaithersburg Maryland 20877
BioXcel Clinical Research Site Las Vegas Nevada 89102
BioXcel Clinical Research Site Berlin New Jersey 08009
BioXcel Clinical Research Site Marlton New Jersey 08053
BioXcel Clinical Research Site Charleston South Carolina 29407
BioXcel Clinical Research Site Austin Texas 78754
BioXcel Clinical Research Site DeSoto Texas 75115
BioXcel Clinical Research Site Richardson Texas 75080

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04268303, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 3, 2026 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04268303 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →