Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder

Sponsor

BioXcel Therapeutics Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05025605

Collaborator

Cognitive Research Corporation (Industry)

120

Enrollment

Locations

Arms

21.9

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizo-Affective Disorder Schizophreniform; Schizophrenic Bipolar Disorder I Bipolar Disorder II	Drug: BXCL501 Drug: Placebo Film Drug: BXCL501	Phase 1

Detailed Description

The study will enroll approximately 120 subjects randomized to dose regimens of 80 µg or 120 µg BCXL501 or placebo. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Study will randomize subjects 1:1:1 to receive BXCL501 80 μg, BXCL501 120 μg, or matching placebo film,Study will randomize subjects 1:1:1 to receive BXCL501 80 μg, BXCL501 120 μg, or matching placebo film,

Masking:

Double (Participant, Investigator)

Masking Description:

Double-Blind, Placebo controlled

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 27, 2021

Anticipated Primary Completion Date :

Jun 24, 2023

Anticipated Study Completion Date :

Jun 24, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 80 Micrograms Sublingual film containing 80 micrograms Dexmedetomidine	Drug: BXCL501 Sublingual film containing 80 Micrograms BXCL501 Other Names: Dexmedetomidine
Experimental: 120 Micrograms Sublingual film containing 120 micrograms Dexmedetomidine	Drug: BXCL501 Sublingual film containing 120 Micrograms BXCL501 Other Names: Dexmedetomidine
Placebo Comparator: Placebo Sublingual Placebo film	Drug: Placebo Film Matching Sublingual Placebo film Other Names: Placebo

Arm

Intervention/Treatment

Experimental: 80 Micrograms

Sublingual film containing 80 micrograms Dexmedetomidine

Drug: BXCL501

Sublingual film containing 80 Micrograms BXCL501

Other Names:

Dexmedetomidine

Experimental: 120 Micrograms

Sublingual film containing 120 micrograms Dexmedetomidine

Drug: BXCL501

Sublingual film containing 120 Micrograms BXCL501

Other Names:

Dexmedetomidine

Placebo Comparator: Placebo

Sublingual Placebo film

Drug: Placebo Film

Matching Sublingual Placebo film

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

Primary End Point [120 minutes]
Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score

Secondary Outcome Measures

Key Secondary End Point [90, 60, 45, 30, 20,10 minutes]
Absolute change from baseline in the PEC total score

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bioxcel Clinical Research Site	Hialeah	Florida	United States	33016
2	BioXcel Clinical Research Site	Atlanta	Georgia	United States	30331
3	Bioxcel Clinical Research Site	Decatur	Georgia	United States	30030
4	BioXcel Clinical Research Site	DeSoto	Texas	United States	75115