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NCT04251910 · ClinicalTrials.gov registry record · Phase 1
Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia
A Phase 1 study, sponsored by BioXcel Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT04251910: Completed Phase 1 study, sponsored by BioXcel Therapeutics.
NCT04251910 is a Phase 1 study that has completed, run by BioXcel Therapeutics. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04251910, a Phase 1 study, has completed, sponsored by BioXcel Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
This is an adaptive Phase 1b/2 trial design. It is randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL-501 dosing in adult (65 years and older) males and females with acute agitation associated with dementia. Evaluation of 3 doses are planned.
Primary Outcome
The change in PEC score was evaluated at 2 hours following the administration of the BXCL501 60 mcg, and BXCL501 30 mcg (for Part A) and BXCL501 40 mcg (for Part B) versus placebo. PEC is the sum of 5 subscales (poor impulse control, tension, hostility, uncooperativeness, and excitement, each subscale ranging from 1 to 7) and thus ranges from 5 to 35. Change from baseline (pre-dose) PEC total score, with negative values is in favor of improvement.
Interventions
- DRUG Sublingual film containing Dexmedetomidine
- DRUG Sublingual Placebo Film
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-12-27 |
| Est. Completion | 2022-01-24 |
| Phase | Phase 1 |
What the finished NCT04251910 record still lists
NCT04251910 is an interventional study that assigns participants to a tested intervention. The registered 100 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 (67% higher).
The record links to 0 conditions, and to 2 interventions - of which Sublingual film containing Dexmedetomidine is the first listed.
NCT04251910 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04251910 about?
NCT04251910 is a clinical study titled "Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia". This is an adaptive Phase 1b/2 trial design. It is randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL-501 dosing in adult (65 years and older) males and females with acute agitation associated with dementi...
What is the current status of trial NCT04251910?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2019-12-27. Estimated completion is 2022-01-24.
What interventions are being tested in trial NCT04251910?
The interventions under investigation include: Sublingual film containing Dexmedetomidine (DRUG), Sublingual Placebo Film (DRUG).
Who is sponsoring clinical trial NCT04251910?
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 NCT04251910's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 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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