xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05974527</url>
    </required_header>
    <id_info>
      <org_study_id>2023p001864</org_study_id>
      <nct_id>NCT05974527</nct_id>
    </id_info>
    <brief_title>Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department</brief_title>
    <official_title>Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Brigham and Women's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Brigham and Women's Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single-arm pilot study to examine the impact of BXCL501 (sublingual film&#xD;
        formulation of dexmedetomidine) administration on reducing the severity of undifferentiated&#xD;
        acute agitation in patients presenting to the emergency department with underlying bipolar&#xD;
        disorder or schizophrenia. This study is designed to evaluate BXCL501 for its FDA-approved&#xD;
        indication -- treatment of agitation associated with bipolar disorder or schizophrenia --&#xD;
        applied in the emergency department setting.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This pilot study will enroll 30 male and female adults with primary psychiatric complaint and&#xD;
        a documented diagnosis of bipolar I disorder, bipolar II disorder, schizophrenia,&#xD;
        schizoaffective disorder, or schizophreniform disorder, presenting to the emergency&#xD;
        department with clinical signs of acute agitation. Eligible subjects will receive an initial&#xD;
        dose of BXCL501 (180mcg) and a repeat dose (90mcg) 2 hours after the first BXCL501 dose in&#xD;
        the event of persistent or recurrent agitation (up to two repeat doses) while under medical&#xD;
        supervision in the emergency department. Efficacy and safety assessments will be conducted&#xD;
        periodically before and after dosing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Absolute change from baseline in the Altered Mental Status Scale (AMSS) score</measure>
      <time_frame>120 minutes</time_frame>
      <description>AMSS is a 9-point scale ranging from -4 (most sedated) to 4 (most agitated).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Absolute change from baseline in the Richmond Agitation Sedation Scale (RASS) score</measure>
      <time_frame>120 minutes</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute change from baseline in the Behavioral Activity Rating Scale (BARS) score</measure>
      <time_frame>120 minutes</time_frame>
      <description>BARS is a 7-point scale ranging from 1 (difficult or unable to arouse) to 7 (violent, requires restraints).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute change from baseline in the Broset Violence Checklist (BVC) score</measure>
      <time_frame>120 minutes</time_frame>
      <description>BVC is a six-item instrument with a total score ranging from 0 (no agitation) to 6 (severely agitated).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Times, in minutes, from BXCL501 administration to adequate sedation, defined as Altered Mental Status Scale (AMSS) score &lt;1</measure>
      <time_frame>To be determined - will be measured for 120 minutes</time_frame>
      <description>AMSS is a 9-point scale ranging from -4 (most sedated) to 4 (most agitated).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Times, in minutes, from BXCL501 administration to adequate sedation, defined as Richmond Agitation Sedation Scale (RASS) score &lt;1</measure>
      <time_frame>To be determined - will be measured for 120 minutes</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Times, in minutes, from BXCL501 administration to adequate sedation, defined as Behavioral Activity Rating Scale (BARS) score &lt;5</measure>
      <time_frame>To be determined - will be measured for 120 minutes</time_frame>
      <description>BARS is a 7-point scale ranging from 1 (difficult or unable to arouse) to 7 (violent, requires restraints).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Times, in minutes, from BXCL501 administration to adequate sedation, defined as Broset Violence Checklist (BVC) score &lt;1</measure>
      <time_frame>To be determined - will be measured for 120 minutes</time_frame>
      <description>BVC is a six-item instrument with a total score ranging from 0 (no agitation) to 6 (severely agitated).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Agitation</condition>
    <condition>Schizophrenia</condition>
    <condition>Schizoaffective Disorder</condition>
    <condition>Schizophreniform Disorders</condition>
    <condition>Bipolar Disorder</condition>
    <arm_group>
      <arm_group_label>Intervention - BXCL501</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sublingual film containing dexmedetomidine (BXCL501)</intervention_name>
      <description>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.</description>
      <arm_group_label>Intervention - BXCL501</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  English speaking adults age ≥18 years&#xD;
  &#xD;
            -  Patients with an established diagnosis of (1) bipolar I disorder, (2) bipolar II&#xD;
               disorder, (3) schizophrenia, (4) schizoaffective disorder, or (5) schizophreniform&#xD;
               disorder&#xD;
  &#xD;
            -  Judged to be clinically agitated at the time of Screening and Baseline with a AMSS ≥2&#xD;
  &#xD;
            -  Able to read, understand, and provide written informed consent&#xD;
  &#xD;
            -  Subject judged to be likely capable of self-administration of BXCL501 sublingually or&#xD;
               buccally&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Likely to be discharged, admitted, or transferred from the ED within 6 hours after&#xD;
               study medication administration&#xD;
  &#xD;
            -  Administration of benzodiazepines or antipsychotic drugs in the 2 hours before study&#xD;
               treatment&#xD;
  &#xD;
            -  Treatment with alpha-1 noradrenergic antagonists&#xD;
  &#xD;
            -  Female patients who are pregnant or are breastfeeding&#xD;
  &#xD;
            -  Hypotension (systolic blood pressure &lt;100 mmHg or diastolic blood pressure &lt;60 mmHg)&#xD;
               and/or bradycardia (heart rate &lt;55 beats per minute) at the time of Screening or&#xD;
               Baseline evaluation&#xD;
  &#xD;
            -  History of dysautonomia&#xD;
  &#xD;
            -  Patient with a known diagnosis of familial long QT syndrome, second degree or third&#xD;
               degree atrioventricular block without pacemaker, or sick sinus syndrome&#xD;
  &#xD;
            -  Patients with serious or unstable medical illnesses determined by the study&#xD;
               investigators or qualified designees&#xD;
  &#xD;
            -  Patients with history of allergic reactions to dexmedetomidine&#xD;
  &#xD;
            -  Patients previously enrolled and completed the current study&#xD;
  &#xD;
            -  Patients actively enrolled in other ED-based studies involving pharmacological or&#xD;
               behavioral interventions&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dana Im, MD</last_name>
      <phone>617-732-5640</phone>
      <email>dim@bwh.harvard.edu</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
      <investigator_full_name>Dana Im, MD, MPHIL, MPP</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psychomotor Agitation</mesh_term>
      <mesh_term>Emergencies</mesh_term>
      <mesh_term>Schizophrenia</mesh_term>
      <mesh_term>Bipolar Disorder</mesh_term>
      <mesh_term>Psychotic Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexmedetomidine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05974527
  org study id: 2023p001864
  nct id: NCT05974527
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Absolute change from baseline in the Altered Mental Status Scale (AMSS) score
  time frame: 120 minutes
  description: AMSS is a 9-point scale ranging from -4 (most sedated) to 4 (most agitated).
  measure: Absolute change from baseline in the Richmond Agitation Sedation Scale (RASS) score
  time frame: 120 minutes
  description: 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).
  measure: Absolute change from baseline in the Behavioral Activity Rating Scale (BARS) score
  time frame: 120 minutes
  description: BARS is a 7-point scale ranging from 1 (difficult or unable to arouse) to 7 (violent, requires restraints).
  measure: Absolute change from baseline in the Broset Violence Checklist (BVC) score
  time frame: 120 minutes
  description: BVC is a six-item instrument with a total score ranging from 0 (no agitation) to 6 (severely agitated).
  measure: 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
  description: AMSS is a 9-point scale ranging from -4 (most sedated) to 4 (most agitated).
  measure: 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
  description: 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).
  measure: 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
  description: BARS is a 7-point scale ranging from 1 (difficult or unable to arouse) to 7 (violent, requires restraints).
  measure: 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
  description: BVC is a six-item instrument with a total score ranging from 0 (no agitation) to 6 (severely agitated).
  arm group label: Intervention - BXCL501
  arm group type: Experimental
  intervention type: Drug
  intervention name: Sublingual film containing dexmedetomidine (BXCL501)
  description: 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.
  arm group label: Intervention - BXCL501
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Dana Im, MD
  phone: 617-732-5640
  email: dim@bwh.harvard.edu
  responsible party type: Principal Investigator
  investigator affiliation: Brigham and Women's Hospital
  investigator full name: Dana Im, MD, MPHIL, MPP
  investigator title: Principal Investigator
  mesh term: Psychomotor Agitation
  mesh term: Emergencies
  mesh term: Schizophrenia
  mesh term: Bipolar Disorder
  mesh term: Psychotic Disorders
  mesh term: Dexmedetomidine