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

NCT06041646 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-01-02

Study results available
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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.

Conditions

Interventions

DRUG

Sublingual film containing Igalmi

Sublingual film containing 180 µg of Igalmi (dexmedetomidine)

Sponsors & Collaborators

  • Lotus Clinical Research, LLC

    collaborator OTHER

  • BioXcel Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Robert Risinger, MD · BioXcel Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2024-04-29
Completion
2024-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06041646 on ClinicalTrials.gov