A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
BioXcel Therapeutics Inc
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.
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 periodi…
Eligibility
- Age range
- 10–17 years
- Sex
- All
- Healthy volunteers
- No
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 agitat…
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
Locations (5)
- BioXcel Clinical Research SiteAnaheim, California
- Bioxcel Clinical Research SiteHialeah, Florida
- BioXcel Clinical Research SiteAtlanta, Georgia
- Bioxcel Clinical Research SiteDecatur, Georgia
- BioXcel Clinical Research SiteDeSoto, Texas