Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia
Public ClinicalTrials.gov record NCT04010305. 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 Ib Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine Efficacy, Pharmacokinetics and Safety of BXCL501 in Agitation Associated With Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a two-stage adaptive Phase Ib trial design, that will identify two doses (lowest dose with clinical benefit and highest safe dose) in a first stage and better evaluate safety, tolerability and variability of effect in the second stage.
Study identification
- NCT ID
- NCT04010305
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 135 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 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
- May 21, 2019
- Primary completion
- Jul 30, 2019
- Completion
- Jul 30, 2019
- Last update posted
- Aug 10, 2026
2019
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 12
| 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 | Lemon Grove | California | 91945 | — |
| 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 | Atlanta | Georgia | 30331 | — |
| BioXcel Clinical Research Site | Gaithersburg | Maryland | 20877 | — |
| BioXcel Clinical Research Site | Flowood | Mississippi | 39232 | — |
| BioXcel Clinical Research Site | Berlin | New Jersey | 08009 | — |
| BioXcel Clinical Research Site | Austin | Texas | 78754 | — |
| 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 NCT04010305, 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 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04010305 live on ClinicalTrials.gov.