A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
Who is this study for? Children and adolescents with acute agitation and either bipolar disorder or schizophrenia
What treatments are being studied? BXCL501
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:
• 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).
• 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).
• Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
• Participants who agree to use a medically acceptable and effective birth control method
Locations
United States
California
BioXcel Clinical Research Site
RECRUITING
Anaheim
Florida
Bioxcel Clinical Research Site
RECRUITING
Hialeah
Georgia
BioXcel Clinical Research Site
COMPLETED
Atlanta
Bioxcel Clinical Research Site
RECRUITING
Decatur
Texas
BioXcel Clinical Research Site
RECRUITING
Desoto
Contact Information
Primary
BioXcel CTM
info@bioxceltherapeutics.com
475-238-6837
Time Frame
Start Date: 2021-08-27
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 140
Treatments
Experimental: 80 Micrograms
Sublingual film containing 80 micrograms Dexmedetomidine
Experimental: 120 Micrograms
Sublingual film containing 120 micrograms Dexmedetomidine
Placebo_comparator: Placebo
Sublingual Placebo film
Experimental: 60 Micrograms
Sublingual film containing 60 micrograms Dexmedetomidine Europe Only
Related Therapeutic Areas
Sponsors
Leads: BioXcel Therapeutics Inc
Collaborators: ProPharma Group