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

NCT ID: NCT05025605

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-27

Study Completion Date

2026-12-31

Brief Summary

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

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Detailed Description

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The study will enroll approximately 140 subjects randomized to dose regimens of 80 µg or 120 µg BCXL501 or placebo (Group one), or 60 µg BCXL501 or placebo (Group two; Europe only). Subjects with acute agitation will include male and female children and adolescents who are either newly admitted to a hospital setting or already admitted and experiencing acute agitation. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Efficacy and safety assessments will be conducted periodically before and after dosing.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-Blind, Placebo-controlled

Study Groups

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80 Micrograms

Sublingual film containing 80 micrograms Dexmedetomidine

Group Type EXPERIMENTAL

BXCL501 80 Micrograms

Intervention Type DRUG

Sublingual film containing 80 Micrograms BXCL501

120 Micrograms

Sublingual film containing 120 micrograms Dexmedetomidine

Group Type EXPERIMENTAL

BXCL501 120 Micrograms

Intervention Type DRUG

Sublingual film containing 120 Micrograms BXCL501

Placebo

Sublingual Placebo film

Group Type PLACEBO_COMPARATOR

Placebo Film

Intervention Type DRUG

Matching Sublingual Placebo film

60 Micrograms

Sublingual film containing 60 micrograms Dexmedetomidine Europe Only

Group Type EXPERIMENTAL

BXCL501 60 Micrograms

Intervention Type DRUG

Sublingual film containing 60 Micrograms BXCL501 Europe Only

Interventions

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BXCL501 80 Micrograms

Sublingual film containing 80 Micrograms BXCL501

Intervention Type DRUG

Placebo Film

Matching Sublingual Placebo film

Intervention Type DRUG

BXCL501 120 Micrograms

Sublingual film containing 120 Micrograms BXCL501

Intervention Type DRUG

BXCL501 60 Micrograms

Sublingual film containing 60 Micrograms BXCL501 Europe Only

Intervention Type DRUG

Other Intervention Names

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Dexmedetomidine Placebo Dexmedetomidine Dexmedetomidine

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cognitive Research Corporation

INDUSTRY

Sponsor Role collaborator

BioXcel Therapeutics Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Risinger, MD

Role: STUDY_CHAIR

BioXcel Therapeutics

Locations

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BioXcel Clinical Research Site

Anaheim, California, United States

Site Status RECRUITING

Bioxcel Clinical Research Site

Hialeah, Florida, United States

Site Status RECRUITING

BioXcel Clinical Research Site

Atlanta, Georgia, United States

Site Status RECRUITING

Bioxcel Clinical Research Site

Decatur, Georgia, United States

Site Status RECRUITING

BioXcel Clinical Research Site

DeSoto, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Regan Dickinson

Role: CONTACT

[email protected]
475-228-2920

Carl Gommoll

Role: CONTACT

[email protected]
475-355-5177

Facility Contacts

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BioXcel CTM

Role: primary

[email protected]
475-254-5899

Bioxcel CTM

Role: primary

[email protected]
475-254-5899

Bioxcel CTM

Role: primary

[email protected]
475-254-5899

Bioxcel CTM

Role: primary

[email protected]
475-254-5899

Bioxcel CTM

Role: primary

[email protected]
475-254-5899

Other Identifiers

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BXCL501-105

Identifier Type: -

Identifier Source: org_study_id

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