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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 is a Phase 1 study that has completed, run by BioXcel Therapeutics. The registered enrollment target is 100 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04251910
The ClinicalTrials.gov registry entry for NCT04251910 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 100 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 Sublingual film containing Dexmedetomidine is the first listed.
NCT04251910 reports 0 study locations.
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.
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