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NCT04010305 · ClinicalTrials.gov registry record · Phase 1
Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia
A Phase 1 study, sponsored by BioXcel Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 135
- Enrollment target
NCT04010305: Completed Phase 1 study, sponsored by BioXcel Therapeutics.
NCT04010305 is a Phase 1 study that has completed, run by BioXcel Therapeutics. The registered enrollment target is 135 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (125% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04010305, a Phase 1 study, has completed, sponsored by BioXcel Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 135 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Positive and Negative Syndrome Scale - Excited Component (PEC). The PEC comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 to 35.
Interventions
- DRUG Placebo film
- DRUG Sublingual film containing BXCL501 (Dexmedetomidine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2019-05-22 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 1 |
What the finished NCT04010305 record still lists
NCT04010305 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (125% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo film is the first listed.
NCT04010305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04010305 about?
NCT04010305 is a clinical study titled "Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia". 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.
What is the current status of trial NCT04010305?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 135 participants. The study started on 2019-05-22. Estimated completion is 2019-07-31.
What interventions are being tested in trial NCT04010305?
The interventions under investigation include: Placebo film (DRUG), Sublingual film containing BXCL501 (Dexmedetomidine) (DRUG).
Who is sponsoring clinical trial NCT04010305?
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 NCT04010305's enrollment target sits among peer trials
135 425th of 2000 higher than 1,574 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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