CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 29 enrolled
Drug / intervention
Sublingual film containing Igalmidrug
Likely dose
Sublingual film containing Igalmi 180 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06041646
NCT06041646Phase 4Completed
CompareCT.gov

Characterization of Tachyphylaxis, Tolerance, and Withdrawal After Discontinuation of Igalmi in Frequently Agitated Schizophrenic or Bipolar Patients After 7 Days of PRN Treatment

BioXcel Therapeutics Inc·interventional·Posted Sep 18, 2023·Updated Jan 2, 2026

In Brief

A Phase 4 clinical trial evaluating Sublingual film containing Igalmi for Bipolar Disorder and 4 related conditions. Completed, enrolled 29 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder, Schizophreniform Disorders
CountriesUnited States
CollaboratorsLotus Clinical Research, LLC

Timeline

Phase 4CompletedFinished
202420252026
First PostedSep 18, 2023
Enrollment StartOct 2, 2023
Primary CompletionApr 29, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.8 years ago

Interventions

Sublingual film containing Igalmidrug

Sublingual film containing 180 µg of Igalmi (dexmedetomidine)