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/NCT06000501</url>
    </required_header>
    <id_info>
      <org_study_id>22-01003</org_study_id>
      <nct_id>NCT06000501</nct_id>
    </id_info>
    <brief_title>Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening</brief_title>
    <official_title>An Open-Label Treatment, Investigator-Initiated Study, on the Duration and Efficacy of Azstarys (Serdexmethylphenidate and Dexmethylphenidate) on Adult ADHD Symptoms and Executive Function in Early Evening</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NYU Langone Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Corium, Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>NYU Langone Health</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        One purpose of this trial is to extend the safety and efficacy evidence basis for Azstarys in&#xD;
        adults with ADHD. This open-label, treatment study will examine the efficacy of Azstarys on&#xD;
        ADHD symptoms using the AISRS 18-item total score on the AISRS-expanded; the Adult ADHD&#xD;
        Investigator Symptom Rating Scale. The investigators will also examine Executive Function&#xD;
        later in the day (early evening, about 12 hours after first morning dosing).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 14, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 28, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 2</measure>
      <time_frame>Baseline, Week 2</time_frame>
      <description>The expanded AISRS is an 18-item questionnaire assessing symptoms of adult ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate more severe symptoms of ADHD.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Expanded AISRS Score from Baseline to Week 5</measure>
      <time_frame>Baseline, Week 5</time_frame>
      <description>The expanded AISRS is an 18-item questionnaire assessing symptoms of adult ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate more severe symptoms of ADHD.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score</measure>
      <time_frame>Baseline, Week 2</time_frame>
      <description>9-item subscale of the AISRS assessing inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater overall inattentive symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score</measure>
      <time_frame>Baseline, Week 5</time_frame>
      <description>9-item subscale of the AISRS assessing inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater overall inattentive symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score</measure>
      <time_frame>Baseline, Week 2</time_frame>
      <description>9-item subscale of the AISRS assessing hyperactive/impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater hyperactive/impulsive symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score</measure>
      <time_frame>Baseline, Week 5</time_frame>
      <description>9-item subscale of the AISRS assessing hyperactive/impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater hyperactive/impulsive symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-Hour Post-Dose TASS Score at Visit 3</measure>
      <time_frame>Week 2 (1-hour Post-Dose)</time_frame>
      <description>18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-Hour Post-Dose TASS Score at Visit 4</measure>
      <time_frame>Week 3 (1-hour Post-Dose)</time_frame>
      <description>18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-Hour Post-Dose TASS Score at Visit 5</measure>
      <time_frame>Week 4 (1-hour Post-Dose)</time_frame>
      <description>18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-Hour Post-Dose TASS Score at Visit 6</measure>
      <time_frame>Week 5 (1-hour Post-Dose)</time_frame>
      <description>18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>4-Hour Post-Dose TASS Score at Visit 3</measure>
      <time_frame>Week 2 (4-hours Post-Dose)</time_frame>
      <description>18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>4-Hour Post-Dose TASS Score at Visit 4</measure>
      <time_frame>Week 3 (4-hours Post-Dose)</time_frame>
      <description>18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>4-Hour Post-Dose TASS Score at Visit 5</measure>
      <time_frame>Week 4 (4-hours Post-Dose)</time_frame>
      <description>18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>4-Hour Post-Dose TASS Score at Visit 6</measure>
      <time_frame>Week 5 (4-hours Post-Dose)</time_frame>
      <description>18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>12-Hour Post-Dose TASS Score at Visit 3</measure>
      <time_frame>Week 2 (12-hours Post-Dose)</time_frame>
      <description>18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>12-Hour Post-Dose TASS Score at Visit 4</measure>
      <time_frame>Week 3 (12-hours Post-Dose)</time_frame>
      <description>18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>12-Hour Post-Dose TASS Score at Visit 5</measure>
      <time_frame>Week 4 (12-hours Post-Dose)</time_frame>
      <description>18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>12-Hour Post-Dose TASS Score at Visit 6</measure>
      <time_frame>Week 5 (12-hours Post-Dose)</time_frame>
      <description>18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3</measure>
      <time_frame>Week 2 (1-hour Post-Dose)</time_frame>
      <description>5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4</measure>
      <time_frame>Week 3 (1-hour Post-Dose)</time_frame>
      <description>5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5</measure>
      <time_frame>Week 4 (1-hour Post-Dose)</time_frame>
      <description>5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3</measure>
      <time_frame>Week 2 (1-hour Post-Dose)</time_frame>
      <description>5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4</measure>
      <time_frame>Week 3 (1-hour Post-Dose)</time_frame>
      <description>5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5</measure>
      <time_frame>Week 4 (1-hour Post-Dose)</time_frame>
      <description>5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 6</measure>
      <time_frame>Week 5 (1-hour Post-Dose)</time_frame>
      <description>5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3</measure>
      <time_frame>Week 2 (1-hour Post-Dose)</time_frame>
      <description>5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4</measure>
      <time_frame>Week 3 (1-hour Post-Dose)</time_frame>
      <description>5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5</measure>
      <time_frame>Week 4 (1-hour Post-Dose)</time_frame>
      <description>5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 6</measure>
      <time_frame>Week 5 (1-hour Post-Dose)</time_frame>
      <description>5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score</measure>
      <time_frame>Baseline, Week 2</time_frame>
      <description>The ASRS is a 31-item questionnaire assessing frequency of ADHD symptoms over the previous 7 days. Items are rate on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 124; higher scores indicate greater frequency of ADHD symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score</measure>
      <time_frame>Baseline, Week 5</time_frame>
      <description>The ASRS is a 31-item questionnaire assessing frequency of ADHD symptoms over the previous 7 days. Items are rate on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 124; higher scores indicate greater frequency of ADHD symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score</measure>
      <time_frame>Baseline, Week 2</time_frame>
      <description>The BRIEF-A is a 75-item self-report questionnaire assessing behavioral issues. Items are rated on a 3-point Likert scale: 0 (never), 1 (sometimes), and 2 (often).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score</measure>
      <time_frame>Baseline, Week 5</time_frame>
      <description>The BRIEF-A is a 75-item self-report questionnaire assessing behavioral issues. Items are rated on a 3-point Likert scale: 0 (never), 1 (sometimes), and 2 (often).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score</measure>
      <time_frame>Baseline, Week 2</time_frame>
      <description>1-item clinician-rated assessment of the severity of a subject's mental illness. The severity of illness is rated as follows: 0 (not assessed), 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill subjects). The total score is the numerical ranking provided by the clinician.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score</measure>
      <time_frame>Baseline, Week 5</time_frame>
      <description>1-item clinician-rated assessment of the severity of a subject's mental illness. The severity of illness is rated as follows: 0 (not assessed), 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill subjects). The total score is the numerical ranking provided by the clinician.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Adult Attention Deficit Hyperactivity Disorder</condition>
    <arm_group>
      <arm_group_label>Adult ADHD Patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Enrolled participants will begin with a two-week observation stabilization before starting treatment with Azstarys. Participants found to have ≥30% change in their total Adult ADHD Investigator Symptom Rating Scale (AISRS) scores during the two-week observation stabilization period treatment will be discontinued from the study. Remaining participants will be dispensed a three-week supply of Azstarys on a weekly basis.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Serdexmethylphenidate/dexmethylphenidate</intervention_name>
      <description>Azstarys capsules for once-daily oral use for three weeks. Flexible dose starting at 39.2 mg serd-mph/7.8 mg d-mph and moving up to 52.3 mg serd-mph/10.4 mg d-mph.</description>
      <arm_group_label>Adult ADHD Patients</arm_group_label>
      <other_name>Azstarys</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults ages 18-60 years, inclusive at the time of consent&#xD;
  &#xD;
            -  Able to provide signed informed consent&#xD;
  &#xD;
            -  Any gender&#xD;
  &#xD;
            -  Subjects with a current primary DSM-5 diagnosis of ADHD of predominantly inattentive&#xD;
               presentation, or combined presentations) as confirmed by the ACDS Version 1.2.5,&#xD;
               Subjects who are not receiving any pharmacological treatment for ADHD must have an&#xD;
               AISRS 18 item total score of AISRS expanded of ≥ 28 at screening. Subjects who were&#xD;
               previously receiving pharmacological treatment for ADHD at screening must have a&#xD;
               minimum total AISRS 18 item of AISRS EXPANDED score of ≥ 22 at screening&#xD;
  &#xD;
            -  Dysthymia and anxiety disorders in remission but stable on psychiatric medication for&#xD;
               three weeks or more at the discretion of principal investigator will be allowed-&#xD;
               medication for these disorders to remain constant for the duration of the protocol.&#xD;
  &#xD;
            -  Subjects who are stimulant naïve.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known hypersensitivity to serdexmethylphenidate, methylphenidate, or product&#xD;
               components.&#xD;
  &#xD;
            -  Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI&#xD;
               within the preceding 14 days.&#xD;
  &#xD;
            -  Lifetime bipolar disorder, psychotic disorders, autism, intellectual disability except&#xD;
               mood disorders accepted under the inclusion criteria at the discretion of the&#xD;
               principal investigator.&#xD;
  &#xD;
            -  Active suicidality within past year, or history of suicide attempt in past 2 years&#xD;
  &#xD;
            -  Any history of severe past drug dependence determined by the MINI (i.e., a focus of&#xD;
               clinical attention or a cause of substantial social or occupational difficulty)&#xD;
  &#xD;
            -  Concurrent substance abuse and/or history of substance use within 6 months&#xD;
  &#xD;
            -  Use of any prescribed benzodiazepine&#xD;
  &#xD;
            -  Any unstable medical or neurological condition; clinically significant medical&#xD;
               abnormalities such as cardiovascular abnormalities, and any chronic condition of the&#xD;
               central nervous system.&#xD;
  &#xD;
            -  Any psychotropic medication usage&#xD;
  &#xD;
            -  Known nonresponse to MPH treatment&#xD;
  &#xD;
            -  History of allergic reaction or sensitivity to MPH&#xD;
  &#xD;
            -  Female of childbearing age, who are breastfeeding, pregnant, planning to be pregnant&#xD;
               or men planning to make a woman pregnant during the study or for one-month post study&#xD;
  &#xD;
            -  PI/clinician discretion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lenard Adler</last_name>
      <role>Principal Investigator</role>
      <affiliation>NYU Langone Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lenard Adler, MD</last_name>
      <phone>2122633580</phone>
      <email>Lenard.Adler@nyulangone.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Terry Leon, RN</last_name>
      <email>Terry.Leon@nyulangone.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>NYU Langone Health</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10016</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexmethylphenidate Hydrochloride</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The study protocol, statistical analysis plan, outcome measure results and adverse event data will be made available on ClinicalTrials.gov. IPD will not be shared due to capacity constraints and privacy concerns.</ipd_description>
    </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/NCT06000501
  org study id: 22-01003
  nct id: NCT06000501
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  One purpose of this trial is to extend the safety and efficacy evidence basis for Azstarys in
        adults with ADHD. This open-label, treatment study will examine the efficacy of Azstarys on
        ADHD symptoms using the AISRS 18-item total score on the AISRS-expanded; the Adult ADHD
        Investigator Symptom Rating Scale. The investigators will also examine Executive Function
        later in the day (early evening, about 12 hours after first morning dosing).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 2
  time frame: Baseline, Week 2
  description: The expanded AISRS is an 18-item questionnaire assessing symptoms of adult ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate more severe symptoms of ADHD.
  measure: Change in Expanded AISRS Score from Baseline to Week 5
  time frame: Baseline, Week 5
  description: The expanded AISRS is an 18-item questionnaire assessing symptoms of adult ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate more severe symptoms of ADHD.
  measure: Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
  time frame: Baseline, Week 2
  description: 9-item subscale of the AISRS assessing inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater overall inattentive symptoms.
  measure: Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
  time frame: Baseline, Week 5
  description: 9-item subscale of the AISRS assessing inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater overall inattentive symptoms.
  measure: Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
  time frame: Baseline, Week 2
  description: 9-item subscale of the AISRS assessing hyperactive/impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater hyperactive/impulsive symptoms.
  measure: Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
  time frame: Baseline, Week 5
  description: 9-item subscale of the AISRS assessing hyperactive/impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater hyperactive/impulsive symptoms.
  measure: 1-Hour Post-Dose TASS Score at Visit 3
  time frame: Week 2 (1-hour Post-Dose)
  description: 18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
  measure: 1-Hour Post-Dose TASS Score at Visit 4
  time frame: Week 3 (1-hour Post-Dose)
  description: 18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
  measure: 1-Hour Post-Dose TASS Score at Visit 5
  time frame: Week 4 (1-hour Post-Dose)
  description: 18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
  measure: 1-Hour Post-Dose TASS Score at Visit 6
  time frame: Week 5 (1-hour Post-Dose)
  description: 18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
  measure: 4-Hour Post-Dose TASS Score at Visit 3
  time frame: Week 2 (4-hours Post-Dose)
  description: 18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
  measure: 4-Hour Post-Dose TASS Score at Visit 4
  time frame: Week 3 (4-hours Post-Dose)
  description: 18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
  measure: 4-Hour Post-Dose TASS Score at Visit 5
  time frame: Week 4 (4-hours Post-Dose)
  description: 18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
  measure: 4-Hour Post-Dose TASS Score at Visit 6
  time frame: Week 5 (4-hours Post-Dose)
  description: 18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
  measure: 12-Hour Post-Dose TASS Score at Visit 3
  time frame: Week 2 (12-hours Post-Dose)
  description: 18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
  measure: 12-Hour Post-Dose TASS Score at Visit 4
  time frame: Week 3 (12-hours Post-Dose)
  description: 18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
  measure: 12-Hour Post-Dose TASS Score at Visit 5
  time frame: Week 4 (12-hours Post-Dose)
  description: 18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
  measure: 12-Hour Post-Dose TASS Score at Visit 6
  time frame: Week 5 (12-hours Post-Dose)
  description: 18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
  measure: 1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
  time frame: Week 2 (1-hour Post-Dose)
  description: 5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
  measure: 1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
  time frame: Week 3 (1-hour Post-Dose)
  description: 5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
  measure: 1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
  time frame: Week 4 (1-hour Post-Dose)
  description: 5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
  measure: 4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
  time frame: Week 2 (1-hour Post-Dose)
  description: 5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
  measure: 4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
  time frame: Week 3 (1-hour Post-Dose)
  description: 5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
  measure: 4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
  time frame: Week 4 (1-hour Post-Dose)
  description: 5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
  measure: 4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 6
  time frame: Week 5 (1-hour Post-Dose)
  description: 5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
  measure: 12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
  time frame: Week 2 (1-hour Post-Dose)
  description: 5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
  measure: 12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
  time frame: Week 3 (1-hour Post-Dose)
  description: 5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
  measure: 12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
  time frame: Week 4 (1-hour Post-Dose)
  description: 5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
  measure: 12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 6
  time frame: Week 5 (1-hour Post-Dose)
  description: 5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
  measure: Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score
  time frame: Baseline, Week 2
  description: The ASRS is a 31-item questionnaire assessing frequency of ADHD symptoms over the previous 7 days. Items are rate on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 124; higher scores indicate greater frequency of ADHD symptoms.
  measure: Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score
  time frame: Baseline, Week 5
  description: The ASRS is a 31-item questionnaire assessing frequency of ADHD symptoms over the previous 7 days. Items are rate on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 124; higher scores indicate greater frequency of ADHD symptoms.
  measure: Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score
  time frame: Baseline, Week 2
  description: The BRIEF-A is a 75-item self-report questionnaire assessing behavioral issues. Items are rated on a 3-point Likert scale: 0 (never), 1 (sometimes), and 2 (often).
  measure: Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score
  time frame: Baseline, Week 5
  description: The BRIEF-A is a 75-item self-report questionnaire assessing behavioral issues. Items are rated on a 3-point Likert scale: 0 (never), 1 (sometimes), and 2 (often).
  measure: Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
  time frame: Baseline, Week 2
  description: 1-item clinician-rated assessment of the severity of a subject's mental illness. The severity of illness is rated as follows: 0 (not assessed), 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill subjects). The total score is the numerical ranking provided by the clinician.
  measure: Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
  time frame: Baseline, Week 5
  description: 1-item clinician-rated assessment of the severity of a subject's mental illness. The severity of illness is rated as follows: 0 (not assessed), 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill subjects). The total score is the numerical ranking provided by the clinician.
  arm group label: Adult ADHD Patients
  arm group type: Experimental
  description: Enrolled participants will begin with a two-week observation stabilization before starting treatment with Azstarys. Participants found to have ≥30% change in their total Adult ADHD Investigator Symptom Rating Scale (AISRS) scores during the two-week observation stabilization period treatment will be discontinued from the study. Remaining participants will be dispensed a three-week supply of Azstarys on a weekly basis.
  intervention type: Drug
  intervention name: Serdexmethylphenidate/dexmethylphenidate
  description: Azstarys capsules for once-daily oral use for three weeks. Flexible dose starting at 39.2 mg serd-mph/7.8 mg d-mph and moving up to 52.3 mg serd-mph/10.4 mg d-mph.
  arm group label: Adult ADHD Patients
  other name: Azstarys
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Lenard Adler
  role: Principal Investigator
  affiliation: NYU Langone Health
  last name: Lenard Adler, MD
  phone: 2122633580
  email: Lenard.Adler@nyulangone.org
  last name: Terry Leon, RN
  email: Terry.Leon@nyulangone.org
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Attention Deficit Disorder with Hyperactivity
  mesh term: Dexmethylphenidate Hydrochloride
  sharing ipd: No
  ipd description: The study protocol, statistical analysis plan, outcome measure results and adverse event data will be made available on ClinicalTrials.gov. IPD will not be shared due to capacity constraints and privacy concerns.