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

Phase 4

Not yet recruiting

• Conditions: Schizoaffective Disorder; Schizophrenia; Bipolar Disorder; Agitation; Schizophreniform Disorders
• Interventions: Drug: Sublingual film containing dexmedetomidine (BXCL501)

• Registration Number: NCT05974527
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-07-26
• Last Update Submitted: 2023-07-26
• Study First Posted: 2023-08-03
• Last Update Posted: 2023-08-03
• Study Start: 2023-09-01
• Primary Completion: 2025-09-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention - BXCL501	Sublingual film containing dexmedetomidine (BXCL501)	-

Primary Outcome Measures

Name	Time	Method
Absolute change from baseline in the Altered Mental Status Scale (AMSS) score	120 minutes	AMSS is a 9-point scale ranging from -4 (most sedated) to 4 (most agitated).

Secondary Outcome Measures

Name	Time	Method
Absolute change from baseline in the Behavioral Activity Rating Scale (BARS) score	120 minutes	BARS is a 7-point scale ranging from 1 (difficult or unable to arouse) to 7 (violent, requires restraints).
Absolute change from baseline in the Richmond Agitation Sedation Scale (RASS) score	120 minutes	RASS is a 10-point scale with four levels of anxiety or agitation (+1 to +4), one denoting a calm, alert state (0), and five levels of sedation (-1 to -5).
Absolute change from baseline in the Broset Violence Checklist (BVC) score	120 minutes	BVC is a six-item instrument with a total score ranging from 0 (no agitation) to 6 (severely agitated).
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	AMSS is a 9-point scale ranging from -4 (most sedated) to 4 (most agitated).
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	RASS is a 10-point scale with four levels of anxiety or agitation (+1 to +4), one denoting a calm, alert state (0), and five levels of sedation (-1 to -5).
Times, in minutes, from BXCL501 administration to adequate sedation, defined as Broset Violence Checklist (BVC) score <1	To be determined - will be measured for 120 minutes	BVC is a six-item instrument with a total score ranging from 0 (no agitation) to 6 (severely agitated).
Times, in minutes, from BXCL501 administration to adequate sedation, defined as Behavioral Activity Rating Scale (BARS) score <5	To be determined - will be measured for 120 minutes	BARS is a 7-point scale ranging from 1 (difficult or unable to arouse) to 7 (violent, requires restraints).