NCT05974527WithdrawnPhase 4
Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Reason given: Study did not start - due to funding issues prior to IRB approval
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 26 Jul 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Schizophrenia, Bipolar disorder
- NCT number
- NCT05974527
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Patients previously enrolled and completed the current study
Other illness
- 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
- Patients with serious or unstable medical illnesses determined by the study investigators or qualified designees
- Patients with history of allergic reactions to dexmedetomidine
Lab values
- Patient with a known diagnosis of familial long QT syndrome, second degree or third degree atrioventricular block without pacemaker, or sick sinus syndrome
Other
- Female patients who are pregnant or are breastfeeding
- Patients actively enrolled in other ED-based studies involving pharmacological or behavioral interventions
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.