NCT05025605

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: BioXcel Therapeutics Inc · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	BXCL501 80 Micrograms	Sublingual film containing 80 Micrograms BXCL501
DRUG	Placebo Film	Matching Sublingual Placebo film
DRUG	BXCL501 120 Micrograms	Sublingual film containing 120 Micrograms BXCL501
DRUG	BXCL501 60 Micrograms	Sublingual film containing 60 Micrograms BXCL501 Europe Only

Timeline

• Start date: 2021-08-27
• Primary completion: 2027-07-31
• Completion: 2027-12-31
• First posted: 2021-08-27
• Last updated: 2026-04-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study