Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04268303 · ClinicalTrials.gov registry record · Phase 3
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia
A Phase 3 study, sponsored by BioXcel Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 380
- Enrollment target
NCT04268303 is a Phase 3 study that has completed, run by BioXcel Therapeutics. The registered enrollment target is 380 participants.
The verdict
NCT04268303, a Phase 3 study, has completed, sponsored by BioXcel Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 380 participants
- Enrollment target
Study Summary
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia. The BXCL501-301 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with schizophrenia, schizoaffective disorder or schizophreniform disorder.
Interventions
- DRUG Placebo Film
- DRUG Sublingual film containing dexmedetomidine (BXCL501)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2020-01-24 |
| Est. Completion | 2020-05-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04268303
The ClinicalTrials.gov registry entry for NCT04268303 describes a study currently listed as completed, categorized as Phase 3. 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 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Film is the first listed.
NCT04268303 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04268303 about?
NCT04268303 is a clinical study titled "Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia". This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia. The BXCL501-301 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associa...
What is the current status of trial NCT04268303?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2020-01-24. Estimated completion is 2020-05-06.
What interventions are being tested in trial NCT04268303?
The interventions under investigation include: Placebo Film (DRUG), Sublingual film containing dexmedetomidine (BXCL501) (DRUG).
Who is sponsoring clinical trial NCT04268303?
This trial is sponsored by BioXcel Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.