WithdrawnPhase 4

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

Stopped: Study did not start - due to funding issues prior to IRB approval

0Started 2023-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 studie…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1I saw a trial about a sublingual form of dexmedetomidine for agitation in the emergency department, but it shows as 'withdrawn' — can you tell me why it was withdrawn and what that means for my options?
2Since this trial was specifically for people with conditions like schizophrenia, schizoaffective disorder, or bipolar disorder who were experiencing agitation in the ER, is sublingual dexmedetomidine something that's already approved and available to me outside of a clinical trial?
3This was a Phase 4 study, which I understand means the drug was already approved — so is there existing safety and effectiveness data on BXCL501 that you could walk me through before we decide if it's worth pursuing?
4Because this trial was designed to measure changes in agitation severity using a scale called the Altered Mental Status Scale, what tools or approaches do you currently use to manage my agitation in an emergency setting, and how do they compare?
5Since this trial was withdrawn and isn't enrolling, are there other active studies or standard treatment paths for managing agitation related to my diagnosis that we should be considering instead?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 120 minutes

Trial details

NCT IDNCT05974527

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Agitation trials