Back to resultsDetermining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
Primary Purpose
Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BXCL501 80 Micrograms
Placebo Film
BXCL501 120 Micrograms
BXCL501 60 Micrograms
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects between the ages of 10-17 years, inclusive, with bipolar disorder (DSM-5 criteria) and 13-17 years, inclusive, in subjects with schizophrenia (DSM-5 criteria).
- Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥14 on the 5 items comprising the PANSS Excited Component (PEC).
- Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
- Participants who agree to use a medically acceptable and effective birth control method
Exclusion Criteria:
- Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening.
- Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
- Patients who are judged to be at significant risk of suicide.
- Patients with serious or unstable medical illnesses.
- Patients who have received an investigational drug within 30 days prior to the current agitation episode.
- Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.
Sites / Locations
- BioXcel Clinical Research SiteRecruiting
- Bioxcel Clinical Research SiteRecruiting
- BioXcel Clinical Research SiteRecruiting
- Bioxcel Clinical Research SiteRecruiting
- BioXcel Clinical Research SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Arm Label
80 Micrograms
120 Micrograms
Placebo
60 Micrograms
Arm Description
Sublingual film containing 80 micrograms Dexmedetomidine
Sublingual film containing 120 micrograms Dexmedetomidine
Sublingual Placebo film
Sublingual film containing 60 micrograms Dexmedetomidine Europe Only
Outcomes
Primary Outcome Measures
Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Secondary Outcome Measures
Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Full Information
NCT ID
NCT05025605
First Posted
August 24, 2021
Last Updated
August 9, 2023
Sponsor
BioXcel Therapeutics Inc
Collaborators
Cognitive Research Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05025605
Brief Title
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioXcel Therapeutics Inc
Collaborators
Cognitive Research Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
Detailed Description
The study will enroll approximately 140 subjects randomized to dose regimens of 80 µg or 120 µg BCXL501 or placebo (Group one), or 60 µg BCXL501 or placebo (Group two; Europe only). Subjects with acute agitation will include male and female children and adolescents who are either newly admitted to a hospital setting or already admitted and experiencing acute agitation. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Efficacy and safety assessments will be conducted periodically before and after dosing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I, Bipolar Disorder II
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Study will randomize subjects in Group one 1:1:1 to receive BXCL501 80 μg, BXCL501 120 μg, or matching placebo film; Group two 2:1 to receive BXCL501 60 μg or matching placebo film
Masking
ParticipantInvestigator
Masking Description
Double-Blind, Placebo-controlled
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
80 Micrograms
Arm Type
Experimental
Arm Description
Sublingual film containing 80 micrograms Dexmedetomidine
Arm Title
120 Micrograms
Arm Type
Experimental
Arm Description
Sublingual film containing 120 micrograms Dexmedetomidine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sublingual Placebo film
Arm Title
60 Micrograms
Arm Type
Experimental
Arm Description
Sublingual film containing 60 micrograms Dexmedetomidine Europe Only
Intervention Type
Drug
Intervention Name(s)
BXCL501 80 Micrograms
Other Intervention Name(s)
Dexmedetomidine
Intervention Description
Sublingual film containing 80 Micrograms BXCL501
Intervention Type
Drug
Intervention Name(s)
Placebo Film
Other Intervention Name(s)
Placebo
Intervention Description
Matching Sublingual Placebo film
Intervention Type
Drug
Intervention Name(s)
BXCL501 120 Micrograms
Other Intervention Name(s)
Dexmedetomidine
Intervention Description
Sublingual film containing 120 Micrograms BXCL501
Intervention Type
Drug
Intervention Name(s)
BXCL501 60 Micrograms
Other Intervention Name(s)
Dexmedetomidine
Intervention Description
Sublingual film containing 60 Micrograms BXCL501 Europe Only
Primary Outcome Measure Information:
Title
Absolute 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) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Time Frame
120 minutes - Group one only
Secondary Outcome Measure Information:
Title
Absolute 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) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Time Frame
90, 60, 45, 30, 20,10 minutes - Group one only
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects between the ages of 10-17 years, inclusive, with bipolar disorder (DSM-5 criteria) and 13-17 years, inclusive, in subjects with schizophrenia (DSM-5 criteria).
Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥14 on the 5 items comprising the PANSS Excited Component (PEC).
Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
Participants who agree to use a medically acceptable and effective birth control method
Exclusion Criteria:
Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening.
Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
Patients who are judged to be at significant risk of suicide.
Patients with serious or unstable medical illnesses.
Patients who have received an investigational drug within 30 days prior to the current agitation episode.
Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Regan Dickinson
Phone
475-228-2920
Email
rdickinson@bioxceltherapeutics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carl Gommoll
Phone
475-355-5177
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
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BioXcel CTM
Phone
475-254-5899
Email
info@bioxceltherapeutics.com
Facility Name
Bioxcel Clinical Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bioxcel CTM
Phone
475-254-5899
Email
info@bioxceltherapeutics.com
Facility Name
BioXcel Clinical Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bioxcel CTM
Phone
475-254-5899
Email
info@bioxceltherapeutics.com
Facility Name
Bioxcel Clinical Research Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bioxcel CTM
Phone
475-254-5899
Email
info@bioxceltherapeutics.com
Facility Name
BioXcel Clinical Research Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bioxcel CTM
Phone
475-254-5899
Email
info@bioxceltherapeutics.com
12. IPD Sharing Statement
Learn more about this trial
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
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