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COMPLETED
NCT06041646
PHASE4

Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder

Sponsor: BioXcel Therapeutics Inc

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2023-10-02

Completion Date

2024-04-29

Last Updated

2026-08-11

Healthy Volunteers

No

Interventions

DRUG

Sublingual film containing Igalmi

Sublingual film containing 180 µg of Igalmi (dexmedetomidine)

Locations (2)

BioXcel Clinical Research Site

Little Rock, Arkansas, United States

BioXcel Clinical Research Site

Rogers, Arkansas, United States