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

A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05025605

Enrollment

140

Registered

2021-08-27

Start date

2021-08-27

Completion date

2027-12-31

Last updated

2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder I, Bipolar Disorder II, Schizo-Affective Disorder, Schizophrenia, Schizophreniform; Schizophrenic

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.

Interventions

DRUGBXCL501 80 Micrograms

Sublingual film containing 80 Micrograms BXCL501

DRUGPlacebo Film

Matching Sublingual Placebo film

DRUGBXCL501 120 Micrograms

Sublingual film containing 120 Micrograms BXCL501

DRUGBXCL501 60 Micrograms

Sublingual film containing 60 Micrograms BXCL501 Europe Only

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Double-Blind, Placebo-controlled

Intervention 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

Eligibility

Sex/Gender

ALL

Age

10 Years to 17 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

United States

Contacts

CONTACTBioXcel CTM

info@bioxceltherapeutics.com475-238-6837

STUDY_CHAIRBioXcel MM, MD

BioXcel Therapeutics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026