RecruitingPhase 1

Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder

United States140 participantsStarted 2021-08-27

Plain-language 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.

Age range10 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score

Timeframe: 120 minutes - Group one only

NCT IDNCT05025605

SponsorBioXcel Therapeutics Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-31

BioXcel CTM

Who can participate

Age range10 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.