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

ConditionsSchizophreniaSchizo-Affective DisorderSchizophreniform; SchizophrenicBipolar Disorder IBipolar Disorder II
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age10-17
SponsorBioXcel Therapeutics Inc

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BXCL501 80 Micrograms

    Drug

    Sublingual film containing 80 Micrograms BXCL501

  • Placebo Film

    Drug

    Matching Sublingual Placebo film

  • BXCL501 120 Micrograms

    Drug

    Sublingual film containing 120 Micrograms BXCL501

  • BXCL501 60 Micrograms

    Drug

    Sublingual film containing 60 Micrograms BXCL501 Europe Only

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: 80 MicrogramsExperimental treatment 1 intervention
Group B: 120 MicrogramsExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Group D: 60 MicrogramsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)

Time frame
120 minutes - Group one only

Secondary outcomes

1

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

The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)

Time frame
90, 60, 45, 30, 20,10 minutes - Group one only

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioXcel Therapeutics Inc

Lead sponsor

ProPharma Group

Collaborator

Source ClinicalTrials.gov
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