Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department

NCT05974527 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2023p001864
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm pilot study to examine the impact of BXCL501 (sublingual film formulation of dexmedetomidine) administration on reducing the severity of undifferentiated acute agitation in patients presenting to the emergency department with underlying bipolar disorder or schizophrenia. This study is designed to evaluate BXCL501 for its FDA-approved indication -- treatment of agitation associated with bipolar disorder or schizophrenia -- applied in the emergency department setting.

Conditions

Agitation; Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in the Altered Mental Status Scale (AMSS) score

  AMSS is a 9-point scale ranging from -4 (most sedated) to 4 (most agitated).

  120 minutes

Secondary Outcomes (7)

• Absolute change from baseline in the Richmond Agitation Sedation Scale (RASS) score

  120 minutes

• Absolute change from baseline in the Behavioral Activity Rating Scale (BARS) score

  120 minutes

• Absolute change from baseline in the Broset Violence Checklist (BVC) score

  120 minutes

• Times, in minutes, from BXCL501 administration to adequate sedation, defined as Altered Mental Status Scale (AMSS) score <1

  To be determined - will be measured for 120 minutes

• Times, in minutes, from BXCL501 administration to adequate sedation, defined as Richmond Agitation Sedation Scale (RASS) score <1

  To be determined - will be measured for 120 minutes

Study Arms (1)

Intervention - BXCL501

EXPERIMENTAL

Drug: Sublingual film containing dexmedetomidine (BXCL501)

Interventions

Sublingual film containing dexmedetomidine (BXCL501) DRUG

Enrolled participants will receive an initial dose of BXCL501 180mcg. Following the FDA dosing suggestions, participants with mild or moderate hepatic impairment (Child-Pugh Class A or B) will receive a reduced initial dose of 120mcg and participants with severe hepatic impairment (Child-Pugh Class C) will receive a reduced initial dose of 90mcg. Geriatric patients (≥ 65 years old) will receive a reduced initial dose of 120mcg.

Intervention - BXCL501

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking adults age ≥18 years
• Patients with an established diagnosis of (1) bipolar I disorder, (2) bipolar II disorder, (3) schizophrenia, (4) schizoaffective disorder, or (5) schizophreniform disorder
• Judged to be clinically agitated at the time of Screening and Baseline with a AMSS ≥2
• Able to read, understand, and provide written informed consent
• Subject judged to be likely capable of self-administration of BXCL501 sublingually or buccally

You may not qualify if:

• Likely to be discharged, admitted, or transferred from the ED within 6 hours after study medication administration
• Administration of benzodiazepines or antipsychotic drugs in the 2 hours before study treatment
• Treatment with alpha-1 noradrenergic antagonists
• Female patients who are pregnant or are breastfeeding
• Hypotension (systolic blood pressure \<100 mmHg or diastolic blood pressure \<60 mmHg) and/or bradycardia (heart rate \<55 beats per minute) at the time of Screening or Baseline evaluation
• History of dysautonomia
• Patient with a known diagnosis of familial long QT syndrome, second degree or third degree atrioventricular block without pacemaker, or sick sinus syndrome
• Patients with serious or unstable medical illnesses determined by the study investigators or qualified designees
• Patients with history of allergic reactions to dexmedetomidine
• Patients previously enrolled and completed the current study
• Patients actively enrolled in other ED-based studies involving pharmacological or behavioral interventions

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

MeSH Terms

Conditions

Psychomotor Agitation; Schizophrenia; Psychotic Disorders; Bipolar Disorder

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: September 1, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01