A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder

BXCL501-105

This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.

2021-08-27

2024-07-31

2024-07-31

Recruiting

Early phase I

140

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 agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening. 2. Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment. 3. Patients who are judged to be at significant risk of suicide. 4. Patients with serious or unstable medical illnesses. 5. Patients who have received an investigational drug within 30 days prior to the current agitation episode. 6. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study will randomize subjects in Group one 1:1:1 to receive BXCL501 80 μg, BXCL501 120 μg, or matching placebo film; Group two 2:1 to receive BXCL501 60 μg or matching placebo film', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double-Blind, Placebo-controlled', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

2023-08-14