Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
Public ClinicalTrials.gov record NCT04276883. 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.
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 Bipolar Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04276883
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 380 participants
Conditions and interventions
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
- Feb 23, 2020
- Primary completion
- May 20, 2020
- Completion
- May 20, 2020
- Last update posted
- Aug 10, 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 | 90703 | — |
| 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 NCT04276883, 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 Aug 10, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04276883 live on ClinicalTrials.gov.