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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05025605
• Other study ID #: BXCL501-105
• Status: Recruiting
• Phase: Phase 1
• Start date: August 27, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: August 2023
• Source: BioXcel Therapeutics Inc
• Contact: Regan Dickinson
• Phone: 475-228-2920
• Email: rdickinson[@]bioxceltherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

1. 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).

2. 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).

3. Patients who have a score of = 4 on at least 1 of the 5 items on the PEC at Baseline.

4. Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria:

1. Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening.

2. Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.

3. Patients who are judged to be at significant risk of suicide.

4. Patients with serious or unstable medical illnesses.

5. Patients who have received an investigational drug within 30 days prior to the current agitation episode.

6. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder I
• Bipolar Disorder II
• Mood Disorders
• Psychotic Disorders
• Schizo-Affective Disorder
• Schizophrenia

Intervention

Drug:
• BXCL501 80 Micrograms
Sublingual film containing 80 Micrograms BXCL501
• Placebo Film
Matching Sublingual Placebo film
• BXCL501 120 Micrograms
Sublingual film containing 120 Micrograms BXCL501
• BXCL501 60 Micrograms
Sublingual film containing 60 Micrograms BXCL501 Europe Only

Locations

Country	Name	City	State
United States	BioXcel Clinical Research Site	Anaheim	California
United States	BioXcel Clinical Research Site	Atlanta	Georgia
United States	Bioxcel Clinical Research Site	Decatur	Georgia
United States	BioXcel Clinical Research Site	DeSoto	Texas
United States	Bioxcel Clinical Research Site	Hialeah	Florida

Sponsors (2)

Lead Sponsor	Collaborator
BioXcel Therapeutics Inc	Cognitive Research Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	120 minutes - Group one only
Secondary	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)	90, 60, 45, 30, 20,10 minutes - Group one only