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

NCT05025605 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BXCL501-105
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Bipolar Disorder I; Bipolar Disorder II; Schizophrenia; Schizo-Affective Disorder; Schizophreniform; Schizophrenic

Outcome Measures

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)

  120 minutes - Group one only

Secondary Outcomes (1)

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

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

Study Arms (4)

80 Micrograms

EXPERIMENTAL

Sublingual film containing 80 micrograms Dexmedetomidine

Drug: BXCL501 80 Micrograms

120 Micrograms

EXPERIMENTAL

Sublingual film containing 120 micrograms Dexmedetomidine

Drug: BXCL501 120 Micrograms

Placebo

PLACEBO COMPARATOR

Sublingual Placebo film

Drug: Placebo Film

60 Micrograms

EXPERIMENTAL

Sublingual film containing 60 micrograms Dexmedetomidine Europe Only

Drug: BXCL501 60 Micrograms

Interventions

BXCL501 120 Micrograms DRUG

Sublingual film containing 120 Micrograms BXCL501

Also known as: Dexmedetomidine

120 Micrograms

BXCL501 60 Micrograms DRUG

Sublingual film containing 60 Micrograms BXCL501 Europe Only

Also known as: Dexmedetomidine

60 Micrograms

BXCL501 80 Micrograms DRUG

Sublingual film containing 80 Micrograms BXCL501

Also known as: Dexmedetomidine

80 Micrograms

Placebo Film DRUG

Matching Sublingual Placebo film

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ProPharma Group: collaborator
• BioXcel Therapeutics Inc: lead

Study Sites (5)

BioXcel Clinical Research Site

Anaheim, California, 92805, United States

RECRUITING

Bioxcel Clinical Research Site

Hialeah, Florida, 33016, United States

RECRUITING

BioXcel Clinical Research Site

Atlanta, Georgia, 30331, United States

COMPLETED

Bioxcel Clinical Research Site

Decatur, Georgia, 30030, United States

RECRUITING

BioXcel Clinical Research Site

DeSoto, Texas, 75115, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Robert Risinger, MD

  BioXcel Therapeutics

  STUDY CHAIR

Central Study Contacts

BioXcel CTM

CONTACT

475-238-6837; info@bioxceltherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind, Placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 27, 2021
• Study Start: August 27, 2021
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (5)