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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: Completed Phase 3 study, sponsored by BioXcel Therapeutics.
NCT04268303 is a Phase 3 study that has completed, run by BioXcel Therapeutics. The registered enrollment target is 380 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe).
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 |
What the finished NCT04268303 record still lists
NCT04268303 is an interventional study that assigns participants to a tested intervention. The registered 380 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Film is the first listed.
NCT04268303 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04268303's enrollment target sits among peer trials
380 983rd of 2000 higher than 1,014 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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