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

August 9, 2023 updated by: BioXcel Therapeutics Inc

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92805
    • Florida
      • Hialeah, Florida, United States, 33016
    • Georgia
      • Atlanta, Georgia, United States, 30331
      • Decatur, Georgia, United States, 30030
    • Texas
      • DeSoto, Texas, United States, 75115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Sublingual Placebo film
Drug: Placebo Film
Matching Sublingual Placebo film
Other Names:
  • Placebo
Experimental: 80 Micrograms
Sublingual film containing 80 micrograms Dexmedetomidine
Drug: BXCL501 80 Micrograms
Sublingual film containing 80 Micrograms BXCL501
Other Names:
  • Dexmedetomidine
Experimental: 120 Micrograms
Sublingual film containing 120 micrograms Dexmedetomidine
Drug: BXCL501 120 Micrograms
Sublingual film containing 120 Micrograms BXCL501
Other Names:
  • Dexmedetomidine
Experimental: 60 Micrograms
Sublingual film containing 60 micrograms Dexmedetomidine Europe Only
Drug: BXCL501 60 Micrograms
Sublingual film containing 60 Micrograms BXCL501 Europe Only
Other Names:
  • Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score
Time Frame: 120 minutes - Group one only
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score
Time Frame: 90, 60, 45, 30, 20,10 minutes - Group one only
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)
90, 60, 45, 30, 20,10 minutes - Group one only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioXcel Therapeutics Inc

Collaborators

Cognitive Research Corporation

Investigators

  • Study Chair: Robert Risinger, MD, BioXcel Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2021

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BXCL501-105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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