AgitationPhase 4NCT05974527
Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department
A Phase 4 study testing Sublingual film containing dexmedetomidine (BXCL501) in people with Agitation and Schizophrenia, run by Brigham and Women's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Agitation, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Sublingual film containing dexmedetomidine (BXCL501)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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.
Read the 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
- Being tested
- Sublingual film containing dexmedetomidine (BXCL501)
- Medical subject headings
- Psychomotor Agitation, Schizophrenia, Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual film containing dexmedetomidine (BXCL501)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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - BXCL501 | Experimental | Not described Receives: Drug: Sublingual film containing dexmedetomidine (BXCL501) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in the Altered Mental Status Scale (AMSS) score
AMSS is a 9-point scale ranging from -4 (most sedated) to 4 (most agitated).
Measured: 120 minutes
Secondary outcomes (7)
Absolute change from baseline in the Richmond Agitation Sedation Scale (RASS) score
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).
Measured: 120 minutes
Absolute change from baseline in the Behavioral Activity Rating Scale (BARS) score
BARS is a 7-point scale ranging from 1 (difficult or unable to arouse) to 7 (violent, requires restraints).
Measured: 120 minutes
Absolute change from baseline in the Broset Violence Checklist (BVC) score
BVC is a six-item instrument with a total score ranging from 0 (no agitation) to 6 (severely agitated).
Measured: 120 minutes
Times, in minutes, from BXCL501 administration to adequate sedation, defined as Altered Mental Status Scale (AMSS) score <1
AMSS is a 9-point scale ranging from -4 (most sedated) to 4 (most agitated).
Measured: To be determined - will be measured for 120 minutes
Times, in minutes, from BXCL501 administration to adequate sedation, defined as Richmond Agitation Sedation Scale (RASS) score <1
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).
Measured: To be determined - will be measured for 120 minutes
Times, in minutes, from BXCL501 administration to adequate sedation, defined as Behavioral Activity Rating Scale (BARS) score <5
BARS is a 7-point scale ranging from 1 (difficult or unable to arouse) to 7 (violent, requires restraints).
Measured: To be determined - will be measured for 120 minutes
Times, in minutes, from BXCL501 administration to adequate sedation, defined as Broset Violence Checklist (BVC) score <1
BVC is a six-item instrument with a total score ranging from 0 (no agitation) to 6 (severely agitated).
Measured: To be determined - will be measured for 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Why it stopped: Study did not start - due to funding issues prior to IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgitationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Im, MD, MPHIL, MPP, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974527
- Sponsor's protocol ID
- 2023p001864
- Status last verified
- Jan 2026
- First submitted
- 26 Jul 2023
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department
- ClinicalTrials.gov ID
- NCT05974527
- Acronym / sponsor ID
- 2023p001864
- Conditions
- Agitation, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Bipolar Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not start - due to funding issues prior to IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention - BXCL501 | Experimental | Drug: Sublingual film containing dexmedetomidine (BXCL501) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Intervention - BXCL501 |
Primary outcome
Absolute change from baseline in the Altered Mental Status Scale (AMSS) score
Time frame: 120 minutes
AMSS is a 9-point scale ranging from -4 (most sedated) to 4 (most agitated).
7 secondary outcomes
Absolute change from baseline in the Richmond Agitation Sedation Scale (RASS) score
Time frame: 120 minutes
Absolute change from baseline in the Behavioral Activity Rating Scale (BARS) score
Time frame: 120 minutes
Absolute change from baseline in the Broset Violence Checklist (BVC) score
Time frame: 120 minutes
Times, in minutes, from BXCL501 administration to adequate sedation, defined as Altered Mental Status Scale (AMSS) score <1
Time frame: To be determined - will be measured for 120 minutes
Times, in minutes, from BXCL501 administration to adequate sedation, defined as Richmond Agitation Sedation Scale (RASS) score <1
Time frame: To be determined - will be measured for 120 minutes
Times, in minutes, from BXCL501 administration to adequate sedation, defined as Behavioral Activity Rating Scale (BARS) score <5
Time frame: To be determined - will be measured for 120 minutes
Times, in minutes, from BXCL501 administration to adequate sedation, defined as Broset Violence Checklist (BVC) score <1
Time frame: To be determined - will be measured for 120 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sublingual film containing dexmedetomidine (BXCL501) in people with Agitation and Schizophrenia, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change from baseline in the Altered Mental Status Scale (AMSS) score (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.