search
Back to results

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

Primary Purpose

Bipolar Disorder, Schizophrenia, Agitation,Psychomotor

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sublingual film containing Igalmi
Sponsored by
BioXcel Therapeutics Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Agitation, Schizophrenia, Bipolar, Dexmedetomidine, tachyphylaxis, tolerance, withdrawal, PRN treatment, Open-Label, PEC, CGI, ACES, Safety, Tolerability, Igalmi

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • BioXcel Clinical Research SiteRecruiting
  • BioXcel Clinical Research SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Active Treatment - 180 mcg of Igalmi (dexmedetomidine)

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Incidence of Adverse Events During the Follow-up Period
Evaluation of withdrawal phenomenon based on the occurrence of adverse events such as tachycardia, systolic hypertension, nausea, or vomiting and the emergence of any new adverse events on ≥2 consecutive days of the 3-day off-treatment follow-up period.

Full Information

First Posted
September 11, 2023
Last Updated
October 12, 2023
Sponsor
BioXcel Therapeutics Inc
Collaborators
Lotus Clinical Research, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT06041646
Brief Title
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioXcel Therapeutics Inc
Collaborators
Lotus Clinical Research, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Open-Label
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment - 180 mcg of Igalmi (dexmedetomidine)
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sublingual film containing Igalmi
Other Intervention Name(s)
Dexmedetomidine, BXCL501
Intervention Description
Sublingual film containing 180 µg of Igalmi (dexmedetomidine)
Primary Outcome Measure Information:
Title
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
Description
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).
Time Frame
Baseline and 2 hours post-dose for all doses administered
Title
Clinical Global Impression - Improvement (CGI-I)
Description
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.
Time Frame
2 hours post-dose for all doses administered
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events During the Follow-up Period
Description
Evaluation of withdrawal phenomenon based on the occurrence of adverse events such as tachycardia, systolic hypertension, nausea, or vomiting and the emergence of any new adverse events on ≥2 consecutive days of the 3-day off-treatment follow-up period.
Time Frame
Day 8 through Day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bethann DeGeronimo, MS
Phone
203-710-4215
Email
bdegeronimo@bioxceltherapeutics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carl Gommoll, MS
Phone
475-355-4177
Email
cgommoll@bioxceltherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Risinger, MD
Organizational Affiliation
BioXcel Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
BioXcel Clinical Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BioXcel CTM
Phone
475-238-6837
Email
info@bioxceltherapeutics.com
Facility Name
BioXcel Clinical Research Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BioXcel CTM
Phone
475-238-6837
Email
info@bioxceltherapeutics.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs