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

NCT ID: NCT06041646

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2024-04-29

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.

Detailed Description

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 (18 to 65 years old, inclusive) with agitation associated with schizophrenia or bipolar disorder. Subjects will be screened for eligibility within 15 days of first dose and no study procedures will occur unless subjects provide written informed consent. Subjects will receive single doses of 180 μg of Igalmi as needed for the treatment of agitation over a period of 7 days followed by a 3- day follow-up period during which time no Igalmi will be administered in an effort to characterize any potential withdrawal. Subjects will sublingually self-administer Igalmi for an agitation episode that reaches a pre-dose PEC total score of 14 or greater, as determined by a trained rater. Safety assessments will be conducted before and after each dose. If the subject's agitation is recurrent or persistent, repeat doses of 90 µg may be administered (no more than 2 repeat doses within a 24-hour period) in the absence of any safety concerns or adverse events.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Treatment - 180 mcg of Igalmi (dexmedetomidine)

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.

Group Type: OTHER

Sublingual film containing Igalmi

Intervention Type: DRUG

Sublingual film containing 180 µg of Igalmi (dexmedetomidine)

Interventions

Sublingual film containing Igalmi

Sublingual film containing 180 µg of Igalmi (dexmedetomidine)

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine; BXCL501

Eligibility Criteria

Inclusion Criteria

1. Male and female subjects between the ages of 18 to 65 years, inclusive.

2. Subjects who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder or bipolar I or II disorder.

3. Subjects who are currently moderate to severely agitated at least 3 days a week.

4. Subjects who read, understand, and provide written informed consent.

5. 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.

6. Subjects who agree to use a medically acceptable and effective birth control method

7. Subjects must be willing to remain in-clinic for the duration of the study.

Exclusion Criteria

1. Subjects with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse during screening.

2. Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 6 hours before study treatment.

3. Subjects with congenital prolonged QT syndrome.

4. Prior treatment with Igalmi

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lotus Clinical Research, LLC

OTHER

Sponsor Role: collaborator

BioXcel Therapeutics Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Risinger, MD

Role: STUDY_CHAIR

BioXcel Therapeutics

Locations

BioXcel Clinical Research Site

Little Rock, Arkansas, United States

BioXcel Clinical Research Site

Rogers, Arkansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BXCL501-404

Identifier Type: -

Identifier Source: org_study_id