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NCT06041646 · ClinicalTrials.gov registry record · Phase 4
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
A Phase 4 study, sponsored by BioXcel Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 29
- Enrollment target
NCT06041646: Completed Phase 4 study, sponsored by BioXcel Therapeutics.
NCT06041646 is a Phase 4 study that has completed, run by BioXcel Therapeutics. The registered enrollment target is 29 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06041646, a Phase 4 study, has completed, sponsored by BioXcel Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 29 participants
- Enrollment target
Study Summary
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar 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 Sublingual film containing Igalmi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2023-10-02 |
| Est. Completion | 2024-04-29 |
| Phase | Phase 4 |
What the finished NCT06041646 record still lists
NCT06041646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Sublingual film containing Igalmi is the first listed.
NCT06041646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06041646 about?
NCT06041646 is a clinical study titled "Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder". This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
What is the current status of trial NCT06041646?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 29 participants. The study started on 2023-10-02. Estimated completion is 2024-04-29.
What interventions are being tested in trial NCT06041646?
The interventions under investigation include: Sublingual film containing Igalmi (DRUG).
Who is sponsoring clinical trial NCT06041646?
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 NCT06041646's enrollment target sits among peer trials
29 1634th of 2000 higher than 366 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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