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

NCT06041646 | Completed Phase 4 Results FDA Drug

• 1 other identifier: BXCL501-404
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief 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

Bipolar Disorder; Schizophrenia; Agitation,Psychomotor; Schizo Affective Disorder; Schizophreniform Disorders

Keywords

Agitation; Schizophrenia; Bipolar; Dexmedetomidine; tachyphylaxis; tolerance; withdrawal; PRN treatment; Open-Label; PEC; CGI; ACES; Safety; Tolerability; Igalmi

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score

  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).

  Baseline and 2 hours post-dose for all doses administered over 7 days.

• Clinical Global Impression - Improvement (CGI-I)

  The Clinical Global Impression - Improvement (CGI-I) for agitation in response to treatment measures the current level of agitation relative to the level of agitation prior to administration of study intervention. The CGI-I scores range from 1 to 7 with a score of 1 indicating very much improved, and a score of 7 indicating very much worse.

  2 hours post-dose for all doses administered over 7 days.

Secondary Outcomes (1)

• Number of Participants With Adverse Events During the Follow-up Period

  Day 8 through Day 10

Study Arms (1)

Active Treatment - 180 mcg of Igalmi (dexmedetomidine)

OTHER

An initial dose of 180 µg of Igalmi as needed for the treatment of agitation over a period of 7 days. In the event of persistent or recurrent agitation, investigators may choose to repeat dose at 90 μg after the 2-hour time point in the absence of dose-limiting adverse events or safety concerns. A maximum of 2 repeat doses will be allowed in a 24-hour period.

Drug: Sublingual film containing Igalmi

Interventions

Sublingual film containing Igalmi DRUG

Sublingual film containing 180 µg of Igalmi (dexmedetomidine)

Also known as: Dexmedetomidine, BXCL501

Active Treatment - 180 mcg of Igalmi (dexmedetomidine)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects between the ages of 18 to 65 years, inclusive.
• Subjects who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder or bipolar I or II disorder.
• Subjects who are currently moderate to severely agitated at least 3 days a week.
• Subjects who read, understand, and provide written informed consent.
• Subjects who are in good general health prior to study participation as determined by a detailed medical history and in the opinion of the Principal Investigator.
• Subjects who agree to use a medically acceptable and effective birth control method
• Subjects must be willing to remain in-clinic for the duration of the study.

You may not qualify if:

• Subjects with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse during screening.
• Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 6 hours before study treatment.
• Subjects with congenital prolonged QT syndrome.
• Prior treatment with Igalmi

Sponsors & Collaborators

• BioXcel Therapeutics Inc: lead
• Lotus Clinical Research, LLC: collaborator

Study Sites (2)

BioXcel Clinical Research Site

Little Rock, Arkansas, 72211, United States

Location

BioXcel Clinical Research Site

Rogers, Arkansas, 72758, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia; Psychomotor Agitation; Psychotic Disorders

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: SVP Clinical and Medical Affairs
• Organization: BioXcel Therapeutics

DKostic@Bioxceltherapeutics.com

(203) 530-5000

Study Officials

• Robert Risinger, MD

  BioXcel Therapeutics

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-Label

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: October 2, 2023
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: January 2, 2026
• Results First Posted: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)