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

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Jul 26, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called BXCL501, which is a type of film that dissolves under the tongue, to see if it can help reduce agitation in patients who come to the emergency department with conditions like bipolar disorder or schizophrenia. Agitation can make someone feel extremely restless or upset, and this study aims to see how well BXCL501 works in calming these patients when they are in a stressful emergency environment.

To participate in this study, you must be an English-speaking adult aged 18 or older who has been diagnosed with bipolar disorder or schizophrenia and is feeling clinically agitated at the time of screening. If you join the study, you will receive the medication while being closely monitored by the medical team. It's important to know that this study is not yet recruiting participants, and there are certain health conditions that could prevent someone from taking part, such as low blood pressure or a history of serious heart problems. Overall, this study is aimed at finding better ways to manage agitation in the emergency department setting.

Gender

ALL

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