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/NCT06041646</url>
    </required_header>
    <id_info>
      <org_study_id>BXCL501-404</org_study_id>
      <nct_id>NCT06041646</nct_id>
    </id_info>
    <brief_title>Tachyphylaxis, Tolerance, &amp; Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder</brief_title>
    <official_title>Characterization of Tachyphylaxis, Tolerance, and Withdrawal After Discontinuation of Igalmi in Frequently Agitated Schizophrenic or Bipolar Patients After 7 Days of PRN Treatment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>BioXcel Therapeutics Inc</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Lotus Clinical Research, LLC</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>BioXcel Therapeutics Inc</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and&#xD;
        withdrawal following repeated doses of Igalmi in adult males and females with agitation&#xD;
        associated with schizophrenia or bipolar disorder.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and&#xD;
        withdrawal following repeated doses of Igalmi in adult males and females (18 to 65 years old,&#xD;
        inclusive) with agitation associated with schizophrenia or bipolar disorder. Subjects will be&#xD;
        screened for eligibility within 15 days of first dose and no study procedures will occur&#xD;
        unless subjects provide written informed consent. Subjects will receive single doses of 180&#xD;
        μg of Igalmi as needed for the treatment of agitation over a period of 7 days followed by a&#xD;
        3- day follow-up period during which time no Igalmi will be administered in an effort to&#xD;
        characterize any potential withdrawal. Subjects will sublingually self-administer Igalmi for&#xD;
        an agitation episode that reaches a pre-dose PEC total score of 14 or greater, as determined&#xD;
        by a trained rater. Safety assessments will be conducted before and after each dose. If the&#xD;
        subject's agitation is recurrent or persistent, repeat doses of 90 µg may be administered (no&#xD;
        more than 2 repeat doses within a 24-hour period) in the absence of any safety concerns or&#xD;
        adverse events.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>
      <intervention_model_description>Open-Label</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score</measure>
      <time_frame>Baseline and 2 hours post-dose for all doses administered</time_frame>
      <description>The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Global Impression - Improvement (CGI-I)</measure>
      <time_frame>2 hours post-dose for all doses administered</time_frame>
      <description>The Clinical Global Impression - Improvement (CGI-I) for agitation in response to treatment measures the current level of agitation relative to the level of agitation prior to administration of study intervention. The CGI-I scores range from 1 to 7 with a score of 1 indicating very much improved, and a score of 7 indicating very much worse.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of Adverse Events During the Follow-up Period</measure>
      <time_frame>Day 8 through Day 10</time_frame>
      <description>Evaluation of withdrawal phenomenon based on the occurrence of adverse events such as tachycardia, systolic hypertension, nausea, or vomiting and the emergence of any new adverse events on ≥2 consecutive days of the 3-day off-treatment follow-up period.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Agitation Associated With Schizophrenia or Bipolar Disorder</condition>
    <condition>Bipolar Disorder</condition>
    <condition>Schizophrenia</condition>
    <condition>Agitation,Psychomotor</condition>
    <arm_group>
      <arm_group_label>Active Treatment - 180 mcg of Igalmi (dexmedetomidine)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>An initial dose of 180 µg of Igalmi as needed for the treatment of agitation over a period of 7 days. In the event of persistent or recurrent agitation, investigators may choose to repeat dose at 90 μg after the 2-hour time point in the absence of dose-limiting adverse events or safety concerns. A maximum of 2 repeat doses will be allowed in a 24-hour period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sublingual film containing Igalmi</intervention_name>
      <description>Sublingual film containing 180 µg of Igalmi (dexmedetomidine)</description>
      <arm_group_label>Active Treatment - 180 mcg of Igalmi (dexmedetomidine)</arm_group_label>
      <other_name>Dexmedetomidine</other_name>
      <other_name>BXCL501</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male and female subjects between the ages of 18 to 65 years, inclusive.&#xD;
  &#xD;
            2. Subjects who have met DSM-5 criteria for schizophrenia, schizoaffective, or&#xD;
               schizophreniform disorder or bipolar I or II disorder.&#xD;
  &#xD;
            3. Subjects who are currently moderate to severely agitated at least 3 days a week.&#xD;
  &#xD;
            4. Subjects who read, understand, and provide written informed consent.&#xD;
  &#xD;
            5. Subjects who are in good general health prior to study participation as determined by&#xD;
               a detailed medical history and in the opinion of the Principal Investigator.&#xD;
  &#xD;
            6. Subjects who agree to use a medically acceptable and effective birth control method&#xD;
  &#xD;
            7. Subjects must be willing to remain in-clinic for the duration of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with agitation caused by acute intoxication, including positive&#xD;
               identification of alcohol by breathalyzer or drugs of abuse during screening.&#xD;
  &#xD;
            2. Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 6 hours before&#xD;
               study treatment.&#xD;
  &#xD;
            3. Subjects with congenital prolonged QT syndrome.&#xD;
  &#xD;
            4. Prior treatment with Igalmi&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Robert Risinger, MD</last_name>
      <role>Study Chair</role>
      <affiliation>BioXcel Therapeutics</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bethann DeGeronimo, MS</last_name>
      <phone>203-710-4215</phone>
      <email>bdegeronimo@bioxceltherapeutics.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Carl Gommoll, MS</last_name>
      <phone>475-355-4177</phone>
      <email>cgommoll@bioxceltherapeutics.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>BioXcel Clinical Research Site</name>
        <address>
          <city>Little Rock</city>
          <state>Arkansas</state>
          <zip>72211</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>BioXcel CTM</last_name>
        <phone>475-238-6837</phone>
        <email>info@bioxceltherapeutics.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>BioXcel Clinical Research Site</name>
        <address>
          <city>Rogers</city>
          <state>Arkansas</state>
          <zip>72758</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>BioXcel CTM</last_name>
        <phone>475-238-6837</phone>
        <email>info@bioxceltherapeutics.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Agitation</keyword>
    <keyword>Schizophrenia</keyword>
    <keyword>Bipolar</keyword>
    <keyword>Dexmedetomidine</keyword>
    <keyword>tachyphylaxis</keyword>
    <keyword>tolerance</keyword>
    <keyword>withdrawal</keyword>
    <keyword>PRN treatment</keyword>
    <keyword>Open-Label</keyword>
    <keyword>PEC</keyword>
    <keyword>CGI</keyword>
    <keyword>ACES</keyword>
    <keyword>Safety</keyword>
    <keyword>Tolerability</keyword>
    <keyword>Igalmi</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psychomotor Agitation</mesh_term>
      <mesh_term>Schizophrenia</mesh_term>
      <mesh_term>Bipolar Disorder</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexmedetomidine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06041646
  org study id: BXCL501-404
  nct id: NCT06041646
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and
        withdrawal following repeated doses of Igalmi in adult males and females with agitation
        associated with schizophrenia or bipolar disorder.
  This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and
        withdrawal following repeated doses of Igalmi in adult males and females (18 to 65 years old,
        inclusive) with agitation associated with schizophrenia or bipolar disorder. Subjects will be
        screened for eligibility within 15 days of first dose and no study procedures will occur
        unless subjects provide written informed consent. Subjects will receive single doses of 180
        μg of Igalmi as needed for the treatment of agitation over a period of 7 days followed by a
        3- day follow-up period during which time no Igalmi will be administered in an effort to
        characterize any potential withdrawal. Subjects will sublingually self-administer Igalmi for
        an agitation episode that reaches a pre-dose PEC total score of 14 or greater, as determined
        by a trained rater. Safety assessments will be conducted before and after each dose. If the
        subject's agitation is recurrent or persistent, repeat doses of 90 µg may be administered (no
        more than 2 repeat doses within a 24-hour period) in the absence of any safety concerns or
        adverse events.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Open-Label
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
  time frame: Baseline and 2 hours post-dose for all doses administered
  description: The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe).
  measure: Clinical Global Impression - Improvement (CGI-I)
  time frame: 2 hours post-dose for all doses administered
  description: The Clinical Global Impression - Improvement (CGI-I) for agitation in response to treatment measures the current level of agitation relative to the level of agitation prior to administration of study intervention. The CGI-I scores range from 1 to 7 with a score of 1 indicating very much improved, and a score of 7 indicating very much worse.
  measure: Incidence of Adverse Events During the Follow-up Period
  time frame: Day 8 through Day 10
  description: Evaluation of withdrawal phenomenon based on the occurrence of adverse events such as tachycardia, systolic hypertension, nausea, or vomiting and the emergence of any new adverse events on ≥2 consecutive days of the 3-day off-treatment follow-up period.
  arm group label: Active Treatment - 180 mcg of Igalmi (dexmedetomidine)
  arm group type: Other
  description: An initial dose of 180 µg of Igalmi as needed for the treatment of agitation over a period of 7 days. In the event of persistent or recurrent agitation, investigators may choose to repeat dose at 90 μg after the 2-hour time point in the absence of dose-limiting adverse events or safety concerns. A maximum of 2 repeat doses will be allowed in a 24-hour period.
  intervention type: Drug
  intervention name: Sublingual film containing Igalmi
  description: Sublingual film containing 180 µg of Igalmi (dexmedetomidine)
  arm group label: Active Treatment - 180 mcg of Igalmi (dexmedetomidine)
  other name: Dexmedetomidine
  other name: BXCL501
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Robert Risinger, MD
  role: Study Chair
  affiliation: BioXcel Therapeutics
  last name: Bethann DeGeronimo, MS
  phone: 203-710-4215
  email: bdegeronimo@bioxceltherapeutics.com
  last name: Carl Gommoll, MS
  phone: 475-355-4177
  email: cgommoll@bioxceltherapeutics.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Psychomotor Agitation
  mesh term: Schizophrenia
  mesh term: Bipolar Disorder
  mesh term: Dexmedetomidine
  sharing ipd: No