RecruitingPhase 1NCT05025605
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
Sponsor
BioXcel Therapeutics Inc
Enrollment
140 participants
Start Date
Aug 27, 2021
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 10 YearsMax Age: 17 Years
Inclusion Criteria4
- 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
Exclusion Criteria6
- Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening.
- Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
- Patients who are judged to be at significant risk of suicide.
- Patients with serious or unstable medical illnesses.
- Patients who have received an investigational drug within 30 days prior to the current agitation episode.
- Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05025605
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