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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 is a Phase 1 study that has completed, run by BioXcel Therapeutics. The registered enrollment target is 135 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04010305
The ClinicalTrials.gov registry entry for NCT04010305 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 135 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.
NCT04010305 reports 0 study locations.
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.
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