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

NCT ID: NCT05974527

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-06-30

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.

Detailed Description

This pilot study will enroll 30 male and female adults with primary psychiatric complaint and a documented diagnosis of bipolar I disorder, bipolar II disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder, presenting to the emergency department with clinical signs of acute agitation. Eligible subjects will receive an initial dose of BXCL501 (180mcg) and a repeat dose (90mcg) 2 hours after the first BXCL501 dose in the event of persistent or recurrent agitation (up to two repeat doses) while under medical supervision in the emergency department. Efficacy and safety assessments will be conducted periodically before and after dosing.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention - BXCL501

Group Type: EXPERIMENTAL

Sublingual film containing dexmedetomidine (BXCL501)

Intervention Type: 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.

Interventions

Sublingual film containing dexmedetomidine (BXCL501)

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 Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dana Im, MD, MPHIL, MPP

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2023p001864

Identifier Type: -

Identifier Source: org_study_id