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

Phase 1

Recruiting

• Conditions: Bipolar Disorder I; Schizophreniform; Schizophrenic; Bipolar Disorder II; Schizophrenia; Schizo-Affective Disorder
• Interventions: Drug: BXCL501 80 Micrograms; Drug: BXCL501 120 Micrograms; Drug: BXCL501 60 Micrograms; Drug: Placebo Film

• Registration Number: NCT05025605
• Lead Sponsor: BioXcel Therapeutics Inc

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.

Study Timeline

• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-24
• Study Start: 2021-08-27
• Study First Posted: 2021-08-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-12
• Primary Completion: 2026-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
80 Micrograms	BXCL501 80 Micrograms	Sublingual film containing 80 micrograms Dexmedetomidine
120 Micrograms	BXCL501 120 Micrograms	Sublingual film containing 120 micrograms Dexmedetomidine
60 Micrograms	BXCL501 60 Micrograms	Sublingual film containing 60 micrograms Dexmedetomidine Europe Only
Placebo	Placebo Film	Sublingual Placebo film

Primary Outcome Measures

Name	Time	Method
Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score	120 minutes - Group one only	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

Name	Time	Method
Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score	90, 60, 45, 30, 20,10 minutes - Group one only	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)

Trial Locations

Locations (2)

Bioxcel Clinical Research Site; 🇺🇸 Decatur, Georgia, United States

BioXcel Clinical Research Site; 🇺🇸 DeSoto, Texas, United States