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

NCT05025605 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • ProPharma Group

    collaborator INDUSTRY

  • BioXcel Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Robert Risinger, MD · BioXcel Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2027-07-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05025605 on ClinicalTrials.gov