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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.

Clinical Trial Description

The study will enroll approximately 120 subjects randomized to dose regimens of 80 µg or 120 µg BCXL501 or placebo. 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 Design

Related Conditions & MeSH terms

NCT number NCT05025605
Study type Interventional
Source BioXcel Therapeutics Inc
Contact Lisa Hemsen
Phone 475-25-5899
Email [email protected]
Status Recruiting
Phase Phase 1
Start date August 27, 2021
Completion date June 24, 2023

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