<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/NCT03247556</url>
  </required_header>
  <id_info>
    <org_study_id>812P304</org_study_id>
    <nct_id>NCT03247556</nct_id>
  </id_info>
  <brief_title>Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD</brief_title>
  <official_title>Evaluation of SPN-812 (Viloxazine Extended-release Capsule) 400 and 600 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Supernus Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Supernus Pharmaceuticals, 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 study will evaluate the efficacy and safety of high doses of SPN-812 in adolescents&#xD;
      (12-17 years old) with ADHD&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group&#xD;
      study to assess the efficacy and safety of SPN-812 as a monotherapy for the treatment of&#xD;
      adolescents 12-17 years old with ADHD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2017</start_date>
  <completion_date type="Actual">February 14, 2019</completion_date>
  <primary_completion_date type="Actual">February 14, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)</measure>
    <time_frame>Baseline and Week 7 (End of Study)</time_frame>
    <description>The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 7 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (&lt;0) represent a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of SPN-812 Assessed by Clinical Global Impression-Improvement (CGI-I) Scale</measure>
    <time_frame>Week 7 (End of Study)</time_frame>
    <description>The first Key Secondary Endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 7 (End of Study). The CGI-I scale is a single item assessment of how much the patient's illness has improved or worsened relative to a baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point Likert scale from 1 to 7, where 1 = &quot;very much improved&quot; and 7 = &quot;very much worse.&quot; Successful therapy is indicated by a lower overall score in subsequent testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of SPN-812 Assessed by Conners 3 - Parent Short Form (C3PS)</measure>
    <time_frame>Baseline and Week 7 (End of Study)</time_frame>
    <description>The second Key Secondary Endpoint was the change from baseline in the Conners 3rd Edition - Parent Short Form (C3PS) Composite T-score at Week 7 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for the assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3PS is completed by a child's parent/guardian and is comprised of 45 items with subsets of items related to six content scales: inattention, hyperactivity/impulsivity, executive functioning, learning problems, defiance/aggression and peer relations. The parent rates his/her child on the first 43 items of the C3PS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently]) based on past month; the last 2 items are fill-in-the-blank. Raw scores are converted to T-scores. Lower change from baseline T-scores (&lt;0) represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of SPN-812 Assessed by Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)</measure>
    <time_frame>Baseline and Week 7 (End of Study)</time_frame>
    <description>The third Key Secondary Endpoint was the change from baseline in the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) Total Average score at Week 7 (End of Study). The WFIRS instrument evaluates ADHD-related functional impairment. The WFIRS-P is completed by the child's parent/guardian and is comprised of 50 items grouped into six domains: Family (10 items), School (10 items, includes learning [4 items] and behavior [6 items]), Life Skills (10 items), Child's Self-Concept (3 items), Social Activities (7 items), and Risky Activities (10 items). The parent/guardian rates each item on a 4-point Likert scale (0-3; where 0=never or not at all to 3= very often or very much) based on their child's behavior past month. A Total Average score was computed by calculating mean rating of all 50 items (ranging from 0 to 3, where a higher value represents more severe functional impairment). Lower change from baseline Total Average scores (&lt;0) represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of SPN-812 Assessed by 50% Responder Rate Per the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)</measure>
    <time_frame>Week 7 (End of Study)</time_frame>
    <description>An additional secondary endpoint was the percentage of responders at Week 7 (End of Study). A responder was defined as a subject who had a 50% or greater reduction (improvement) in their change from baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 7 (End of Study). Values range from 0 to 100%. A higher percentage represents a greater number of responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of SPN-812 Assessed by Stress Index for Parents of Adolescents (SIPA)</measure>
    <time_frame>Baseline and Week 7 (End of Study)</time_frame>
    <description>Another secondary endpoint was the change from baseline in the Stress Index for Parents of Adolescents (SIPA) Total score to Week 7 (End of Study). The SIPA is a 112-item screening/diagnostic instrument for parents of adolescents 11-19 years of age that identifies areas of stress in parent-adolescent interactions. Items 1-90 are rated on a 5-point Likert scale (where SD=Strongly Disagree, D=Disagree, NS=Not Sure, A=Agree, and SA=Strongly Agree) and yields a raw score for 3 Domains (Adolescent Domain, Parent Domain, and Adolescent-Parent Domain) that focus on a parent's perception of their child's personality and on the parent's characteristics and behaviors. The sum of the 3 Domain scores yields the Total (Parent Stress) score (range: 90-450; higher total scores indicate higher levels of stress). Lower change from baseline scores (&lt;0) represent a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of SPN-812 Assessed by the Hyperactivity/Impulsivity Subscale and the Inattention Subscale of the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)</measure>
    <time_frame>Baseline and Week 7 (End of Study)</time_frame>
    <description>An additional secondary endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Hyperactivity/Impulsivity subscale score and Inattention subscale score at Week 7 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 DSM-5 symptoms of ADHD, including 9 items for the Hyperactivity/Impulsivity subscale and 9 items for the Inattention subscale. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). Each subscale score is calculated by adding the responses of all respective 9 items (range: 0-27; the higher the subscale score, the more severe the Hyperactivity/Impulsivity or Inattention symptoms). Lower change from baseline subscale scores (&lt;0) represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of SPN-812 Assessed by Conners 3 - Self Report Short Form</measure>
    <time_frame>Baseline and Week 7 (End of Study)</time_frame>
    <description>An additional secondary endpoint was the change from baseline in the Conners 3rd Edition - Self Report Short Form (C3-SRS) Composite T score at Week 7 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3-SRS, which is only validated in children/adolescents 8-18 years of age, is comprised of 41 items with subsets of items related to five content scales: inattention, hyperactivity/impulsivity, learning problems, aggression and family relations. The subject rates himself/herself on the first 39 items of C3-SRS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently] based on past month; the last 2 items are fill-in-the-blank and do not contribute to the raw score(s). Raw scores are converted to T-scores. Lower change from baseline T-scores (&lt;0) represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved&quot;]</measure>
    <time_frame>Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7</time_frame>
    <description>An additional secondary endpoint was the percentage of subjects who were &quot;improved&quot; by visit; &quot;improved&quot; was defined as a subject who had a Clinical Global Impression - Improvement (CGI-I) score of 1 = &quot;Very Much Improved&quot; or 2 = &quot;Much Improved&quot;. Values range from 0 to 100%. A higher percentage represents a greater number of subjects who were &quot;improved&quot;.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">297</enrollment>
  <condition>ADHD</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, qd, oral capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>400mg SPN-812</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>400mg SPN-812, qd, oral capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>600mg SPN-812</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>600mg SPN-812, qd, oral capsule</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo was administered once daily</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>PBO</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>400mg SPN-812</intervention_name>
    <description>400mg SPN-812 was administered once daily and compared to Placebo</description>
    <arm_group_label>400mg SPN-812</arm_group_label>
    <other_name>SPN-812</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>600mg SPN-812</intervention_name>
    <description>600mg SPN-812 was administered once daily and compared to Placebo</description>
    <arm_group_label>600mg SPN-812</arm_group_label>
    <other_name>SPN-812</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male or female subjects, 12-17 years of age, inclusive.&#xD;
&#xD;
          2. Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental&#xD;
             Disorders-5 (DSM-5), confirmed with the Mini International Neuropsychiatric Interview&#xD;
             for Children and Adolescents (MINI-KID).&#xD;
&#xD;
          3. Attention Deficit/Hyperactivity Disorder Rating Scale-5, Home Version: Adolescent,&#xD;
             Investigator Administered and Scored (ADHD-RS-5) score of at least 28.&#xD;
&#xD;
          4. CGI-S score of at least 4 at screening.&#xD;
&#xD;
          5. Weight of at least 35 kg.&#xD;
&#xD;
          6. Free of medication for the treatment of ADHD for at least one week prior to&#xD;
             randomization and agreement to remain so throughout the study.&#xD;
&#xD;
          7. Considered medically healthy by the Investigator via assessment of physical&#xD;
             examination, medical history, clinical laboratory tests, vital signs, and&#xD;
             electrocardiogram.&#xD;
&#xD;
          8. Written informed consent obtained from the subject's parent or legal representative&#xD;
             and informed assent from the subject, if applicable.&#xD;
&#xD;
          9. Females of childbearing potential (FOCP) must be either sexually inactive (abstinent)&#xD;
             or, if sexually active, must agree to use one of the following acceptable birth&#xD;
             control methods beginning 30 days prior to the first dose, throughout the study:&#xD;
&#xD;
               1. simultaneous use of male condom and intra-uterine contraceptive device placed at&#xD;
                  least four weeks prior to the first study drug administration&#xD;
&#xD;
               2. surgically sterile male partner&#xD;
&#xD;
               3. simultaneous use of male condom and diaphragm with spermicide&#xD;
&#xD;
               4. established hormonal contraceptive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current diagnosis of major psychiatric disorders. Subjects with Major Depressive&#xD;
             Disorder are allowed in the study if the subject is free of episodes both currently&#xD;
             and for the last six months.&#xD;
&#xD;
          2. Current diagnosis of major neurological disorders. Subjects with seizures or a history&#xD;
             of seizure disorder within the immediate family (siblings, parents), or a history of&#xD;
             seizure-like events are excluded from the study.&#xD;
&#xD;
          3. Current diagnosis of significant systemic disease.&#xD;
&#xD;
          4. Evidence of suicidality (defined as either active suicidal plan/intent or active&#xD;
             suicidal thoughts, or more than one lifetime suicide attempt) within the six months&#xD;
             before Screening or at Screening.&#xD;
&#xD;
          5. BMI greater than 95th percentile for the appropriate age and gender.&#xD;
&#xD;
          6. History of an allergic reaction to viloxazine or related drugs.&#xD;
&#xD;
          7. Any food allergy, intolerance, restriction or special diet that, in the opinion of the&#xD;
             Investigator, could contraindicate the subject's participation in this study.&#xD;
&#xD;
          8. Subjects who received any investigational drug within the longer of 30 days or 5&#xD;
             half-lives prior to Day 1 dosing of SM.&#xD;
&#xD;
          9. Any reason, which, in the opinion of the Investigator, would prevent the subject from&#xD;
             participating in the study.&#xD;
&#xD;
         10. Positive drug screen at the Screening Visit. A positive test for amphetamines is&#xD;
             allowed for subjects receiving a stimulant ADHD medication at Screening; the subject&#xD;
             will be required to discontinue the stimulant for the study, beginning at least one&#xD;
             week prior to the Baseline Visit.&#xD;
&#xD;
         11. Pregnancy or refusal to practice abstinence or acceptable birth control during the&#xD;
             study (for female subjects of childbearing potential)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Rubin, MD</last_name>
    <role>Study Director</role>
    <affiliation>Supernus Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alliance for Wellness dba Alliance for Research</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MCB Clinical Research Centers, LLC</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research at Florida Clinical Research Center</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovative Clinical Research, Inc</name>
      <address>
        <city>Lauderhill</city>
        <state>Florida</state>
        <zip>33319</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Clinical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APG Research, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>iResearch Atlanta</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPS Research</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paradigm Research Professionals</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Clinical Trials, Inc.</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gadolin Research, LLC</name>
      <address>
        <city>Beaumont</city>
        <state>Texas</state>
        <zip>77702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bayou City Research Corporation</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Discovery MM Services Inc. Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ericksen Research &amp; Development</name>
      <address>
        <city>Clinton</city>
        <state>Utah</state>
        <zip>84015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <results_first_submitted>June 2, 2021</results_first_submitted>
  <results_first_submitted_qc>June 30, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 2, 2021</results_first_posted>
  <disposition_first_submitted>August 11, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>June 30, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 2, 2021</disposition_first_posted>
  <last_update_submitted>June 30, 2021</last_update_submitted>
  <last_update_submitted_qc>June 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03247556/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03247556/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo oral capsule&#xD;
Treatment A: Placebo was administered once daily</description>
        </group>
        <group group_id="P2">
          <title>400mg SPN-812</title>
          <description>400mg SPN-812 oral capsule&#xD;
Treatment B: SPN-812 was administered once daily and compared to Placebo</description>
        </group>
        <group group_id="P3">
          <title>600mg SPN-812</title>
          <description>600mg SPN-812 oral capsule&#xD;
Treatment C: SPN-812 was administered once daily and compared to Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="97"/>
                <participants group_id="P2" count="100"/>
                <participants group_id="P3" count="99"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="88"/>
                <participants group_id="P3" count="81"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Consent Withdrawn by Caregiver</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Assent/consent Withdrawn by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject did not meet inclusion criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo oral capsule&#xD;
Treatment A: Placebo was administered once daily</description>
        </group>
        <group group_id="B2">
          <title>400mg SPN-812</title>
          <description>400mg SPN-812 oral capsule&#xD;
Treatment B: SPN-812 was administered once daily and compared to Placebo</description>
        </group>
        <group group_id="B3">
          <title>600mg SPN-812</title>
          <description>600mg SPN-812 oral capsule&#xD;
Treatment C: SPN-812 was administered once daily and compared to Placebo</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="96"/>
            <count group_id="B2" value="99"/>
            <count group_id="B3" value="97"/>
            <count group_id="B4" value="292"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.8" spread="1.53"/>
                    <measurement group_id="B2" value="14.0" spread="1.74"/>
                    <measurement group_id="B3" value="13.7" spread="1.52"/>
                    <measurement group_id="B4" value="13.8" spread="1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>12-14 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="72"/>
                    <measurement group_id="B4" value="196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15-17 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="71"/>
                    <measurement group_id="B4" value="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="66"/>
                    <measurement group_id="B4" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="66"/>
                    <measurement group_id="B4" value="193"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="97"/>
                    <measurement group_id="B4" value="292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ADHD-RS-5 Total Score</title>
          <description>The Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. It consists of 18 items that correspond to the 18 ADHD symptoms per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). Total score = sum of 18 items (range: 0 to 54). The higher the score, the more severe the ADHD symptoms (a total score &gt;=28 was an inclusion criterion of this study).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.8" spread="8.06"/>
                    <measurement group_id="B2" value="41.2" spread="7.80"/>
                    <measurement group_id="B3" value="39.8" spread="8.34"/>
                    <measurement group_id="B4" value="39.9" spread="8.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ADHD-RS-5 Inattention</title>
          <description>The Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. It consists of 18 items that correspond to the 18 ADHD symptoms per the DSM-5, including 9 items for the Hyperactivity/Impulsivity (HI) subscale and 9 items for the Inattention (IA) subscale. Each item is rated on a 4-point Likert-type scale (0=never or rarely to 3=very often). The IA Subscale score = sum of all 9 IA items on the ADHD-RS-5 (range: 0 to 27). The higher the score, the more severe the IA symptoms of ADHD.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.4" spread="3.59"/>
                    <measurement group_id="B2" value="22.5" spread="3.70"/>
                    <measurement group_id="B3" value="22.3" spread="3.82"/>
                    <measurement group_id="B4" value="22.4" spread="3.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ADHD-RS-5 Hyperactivity/Impulsivity</title>
          <description>The Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. It consists of 18 items that correspond to the 18 ADHD symptoms per the DSM-5, including 9 items for the Hyperactivity/Impulsivity (HI) subscale and 9 items for the Inattention (IA) subscale. Each item is rated on a 4-point Likert-type scale (0=never or rarely to 3=very often). The HI Subscale score = sum of all 9 HI items on the ADHD-RS-5 (range: 0 to 27). The higher the score, the more severe the HI symptoms of ADHD.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.4" spread="6.36"/>
                    <measurement group_id="B2" value="18.7" spread="5.59"/>
                    <measurement group_id="B3" value="17.5" spread="6.49"/>
                    <measurement group_id="B4" value="17.6" spread="6.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)</title>
        <description>The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 7 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (&lt;0) represent a better outcome.</description>
        <time_frame>Baseline and Week 7 (End of Study)</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo oral capsule&#xD;
Treatment A: Placebo was administered once daily</description>
          </group>
          <group group_id="O2">
            <title>400mg SPN-812</title>
            <description>400mg SPN-812 oral capsule&#xD;
Treatment B: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
          <group group_id="O3">
            <title>600mg SPN-812</title>
            <description>600mg SPN-812 oral capsule&#xD;
Treatment C: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)</title>
          <description>The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 7 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (&lt;0) represent a better outcome.</description>
          <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.2" spread="1.38"/>
                    <measurement group_id="O2" value="-18.3" spread="1.36"/>
                    <measurement group_id="O3" value="-16.7" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0082</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-5.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.93</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.9</ci_lower_limit>
            <ci_upper_limit>-1.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0712</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-3.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.93</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.3</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of SPN-812 Assessed by Clinical Global Impression-Improvement (CGI-I) Scale</title>
        <description>The first Key Secondary Endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 7 (End of Study). The CGI-I scale is a single item assessment of how much the patient's illness has improved or worsened relative to a baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point Likert scale from 1 to 7, where 1 = &quot;very much improved&quot; and 7 = &quot;very much worse.&quot; Successful therapy is indicated by a lower overall score in subsequent testing.</description>
        <time_frame>Week 7 (End of Study)</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo oral capsule&#xD;
Treatment A: Placebo was administered once daily</description>
          </group>
          <group group_id="O2">
            <title>400mg SPN-812</title>
            <description>400mg SPN-812 oral capsule&#xD;
Treatment B: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
          <group group_id="O3">
            <title>600mg SPN-812</title>
            <description>600mg SPN-812 oral capsule&#xD;
Treatment C: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of SPN-812 Assessed by Clinical Global Impression-Improvement (CGI-I) Scale</title>
          <description>The first Key Secondary Endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 7 (End of Study). The CGI-I scale is a single item assessment of how much the patient's illness has improved or worsened relative to a baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point Likert scale from 1 to 7, where 1 = &quot;very much improved&quot; and 7 = &quot;very much worse.&quot; Successful therapy is indicated by a lower overall score in subsequent testing.</description>
          <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="0.12"/>
                    <measurement group_id="O2" value="2.4" spread="0.12"/>
                    <measurement group_id="O3" value="2.6" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0051</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.</method_desc>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0995</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.</method_desc>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of SPN-812 Assessed by Conners 3 - Parent Short Form (C3PS)</title>
        <description>The second Key Secondary Endpoint was the change from baseline in the Conners 3rd Edition - Parent Short Form (C3PS) Composite T-score at Week 7 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for the assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3PS is completed by a child's parent/guardian and is comprised of 45 items with subsets of items related to six content scales: inattention, hyperactivity/impulsivity, executive functioning, learning problems, defiance/aggression and peer relations. The parent rates his/her child on the first 43 items of the C3PS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently]) based on past month; the last 2 items are fill-in-the-blank. Raw scores are converted to T-scores. Lower change from baseline T-scores (&lt;0) represent a better outcome.</description>
        <time_frame>Baseline and Week 7 (End of Study)</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo oral capsule&#xD;
Treatment A: Placebo was administered once daily</description>
          </group>
          <group group_id="O2">
            <title>400mg SPN-812</title>
            <description>400mg SPN-812 oral capsule&#xD;
Treatment B: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
          <group group_id="O3">
            <title>600mg SPN-812</title>
            <description>600mg SPN-812 oral capsule&#xD;
Treatment C: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of SPN-812 Assessed by Conners 3 - Parent Short Form (C3PS)</title>
          <description>The second Key Secondary Endpoint was the change from baseline in the Conners 3rd Edition - Parent Short Form (C3PS) Composite T-score at Week 7 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for the assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3PS is completed by a child's parent/guardian and is comprised of 45 items with subsets of items related to six content scales: inattention, hyperactivity/impulsivity, executive functioning, learning problems, defiance/aggression and peer relations. The parent rates his/her child on the first 43 items of the C3PS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently]) based on past month; the last 2 items are fill-in-the-blank. Raw scores are converted to T-scores. Lower change from baseline T-scores (&lt;0) represent a better outcome.</description>
          <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
          <units>T-score</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.6" spread="0.89"/>
                    <measurement group_id="O2" value="-7.5" spread="0.87"/>
                    <measurement group_id="O3" value="-6.9" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1377</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-1.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.26</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.3</ci_lower_limit>
            <ci_upper_limit>0.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3130</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-1.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.25</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.7</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of SPN-812 Assessed by Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)</title>
        <description>The third Key Secondary Endpoint was the change from baseline in the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) Total Average score at Week 7 (End of Study). The WFIRS instrument evaluates ADHD-related functional impairment. The WFIRS-P is completed by the child's parent/guardian and is comprised of 50 items grouped into six domains: Family (10 items), School (10 items, includes learning [4 items] and behavior [6 items]), Life Skills (10 items), Child's Self-Concept (3 items), Social Activities (7 items), and Risky Activities (10 items). The parent/guardian rates each item on a 4-point Likert scale (0-3; where 0=never or not at all to 3= very often or very much) based on their child's behavior past month. A Total Average score was computed by calculating mean rating of all 50 items (ranging from 0 to 3, where a higher value represents more severe functional impairment). Lower change from baseline Total Average scores (&lt;0) represent a better outcome.</description>
        <time_frame>Baseline and Week 7 (End of Study)</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo oral capsule&#xD;
Treatment A: Placebo was administered once daily</description>
          </group>
          <group group_id="O2">
            <title>400mg SPN-812</title>
            <description>400mg SPN-812 oral capsule&#xD;
Treatment B: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
          <group group_id="O3">
            <title>600mg SPN-812</title>
            <description>600mg SPN-812 oral capsule&#xD;
Treatment C: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of SPN-812 Assessed by Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)</title>
          <description>The third Key Secondary Endpoint was the change from baseline in the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) Total Average score at Week 7 (End of Study). The WFIRS instrument evaluates ADHD-related functional impairment. The WFIRS-P is completed by the child's parent/guardian and is comprised of 50 items grouped into six domains: Family (10 items), School (10 items, includes learning [4 items] and behavior [6 items]), Life Skills (10 items), Child's Self-Concept (3 items), Social Activities (7 items), and Risky Activities (10 items). The parent/guardian rates each item on a 4-point Likert scale (0-3; where 0=never or not at all to 3= very often or very much) based on their child's behavior past month. A Total Average score was computed by calculating mean rating of all 50 items (ranging from 0 to 3, where a higher value represents more severe functional impairment). Lower change from baseline Total Average scores (&lt;0) represent a better outcome.</description>
          <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.23" spread="0.035"/>
                    <measurement group_id="O2" value="-0.32" spread="0.034"/>
                    <measurement group_id="O3" value="-0.23" spread="0.035"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0698</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-0.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.049</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.19</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9756</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>0.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.050</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.10</ci_lower_limit>
            <ci_upper_limit>0.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of SPN-812 Assessed by 50% Responder Rate Per the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)</title>
        <description>An additional secondary endpoint was the percentage of responders at Week 7 (End of Study). A responder was defined as a subject who had a 50% or greater reduction (improvement) in their change from baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 7 (End of Study). Values range from 0 to 100%. A higher percentage represents a greater number of responders.</description>
        <time_frame>Week 7 (End of Study)</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo oral capsule&#xD;
Treatment A: Placebo was administered once daily</description>
          </group>
          <group group_id="O2">
            <title>400mg SPN-812</title>
            <description>400mg SPN-812 oral capsule&#xD;
Treatment B: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
          <group group_id="O3">
            <title>600mg SPN-812</title>
            <description>600mg SPN-812 oral capsule&#xD;
Treatment C: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of SPN-812 Assessed by 50% Responder Rate Per the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)</title>
          <description>An additional secondary endpoint was the percentage of responders at Week 7 (End of Study). A responder was defined as a subject who had a 50% or greater reduction (improvement) in their change from baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 7 (End of Study). Values range from 0 to 100%. A higher percentage represents a greater number of responders.</description>
          <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.9"/>
                    <measurement group_id="O2" value="48.2"/>
                    <measurement group_id="O3" value="46.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0349</p_value>
            <method>Regression, Logistic</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>15.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.3</ci_lower_limit>
            <ci_upper_limit>29.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0698</p_value>
            <method>Regression, Logistic</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>13.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>27.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of SPN-812 Assessed by Stress Index for Parents of Adolescents (SIPA)</title>
        <description>Another secondary endpoint was the change from baseline in the Stress Index for Parents of Adolescents (SIPA) Total score to Week 7 (End of Study). The SIPA is a 112-item screening/diagnostic instrument for parents of adolescents 11-19 years of age that identifies areas of stress in parent-adolescent interactions. Items 1-90 are rated on a 5-point Likert scale (where SD=Strongly Disagree, D=Disagree, NS=Not Sure, A=Agree, and SA=Strongly Agree) and yields a raw score for 3 Domains (Adolescent Domain, Parent Domain, and Adolescent-Parent Domain) that focus on a parent's perception of their child's personality and on the parent's characteristics and behaviors. The sum of the 3 Domain scores yields the Total (Parent Stress) score (range: 90-450; higher total scores indicate higher levels of stress). Lower change from baseline scores (&lt;0) represent a better outcome</description>
        <time_frame>Baseline and Week 7 (End of Study)</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo oral capsule&#xD;
Treatment A: Placebo was administered once daily</description>
          </group>
          <group group_id="O2">
            <title>400mg SPN-812</title>
            <description>400mg SPN-812 oral capsule&#xD;
Treatment B: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
          <group group_id="O3">
            <title>600mg SPN-812</title>
            <description>600mg SPN-812 oral capsule&#xD;
Treatment C: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of SPN-812 Assessed by Stress Index for Parents of Adolescents (SIPA)</title>
          <description>Another secondary endpoint was the change from baseline in the Stress Index for Parents of Adolescents (SIPA) Total score to Week 7 (End of Study). The SIPA is a 112-item screening/diagnostic instrument for parents of adolescents 11-19 years of age that identifies areas of stress in parent-adolescent interactions. Items 1-90 are rated on a 5-point Likert scale (where SD=Strongly Disagree, D=Disagree, NS=Not Sure, A=Agree, and SA=Strongly Agree) and yields a raw score for 3 Domains (Adolescent Domain, Parent Domain, and Adolescent-Parent Domain) that focus on a parent's perception of their child's personality and on the parent's characteristics and behaviors. The sum of the 3 Domain scores yields the Total (Parent Stress) score (range: 90-450; higher total scores indicate higher levels of stress). Lower change from baseline scores (&lt;0) represent a better outcome</description>
          <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.1" spread="3.40"/>
                    <measurement group_id="O2" value="-23.3" spread="3.33"/>
                    <measurement group_id="O3" value="-14.5" spread="3.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1259</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-7.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.76</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.6</ci_lower_limit>
            <ci_upper_limit>2.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7417</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>1.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.78</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.8</ci_lower_limit>
            <ci_upper_limit>10.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of SPN-812 Assessed by the Hyperactivity/Impulsivity Subscale and the Inattention Subscale of the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)</title>
        <description>An additional secondary endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Hyperactivity/Impulsivity subscale score and Inattention subscale score at Week 7 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 DSM-5 symptoms of ADHD, including 9 items for the Hyperactivity/Impulsivity subscale and 9 items for the Inattention subscale. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). Each subscale score is calculated by adding the responses of all respective 9 items (range: 0-27; the higher the subscale score, the more severe the Hyperactivity/Impulsivity or Inattention symptoms). Lower change from baseline subscale scores (&lt;0) represent a better outcome.</description>
        <time_frame>Baseline and Week 7 (End of Study)</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo oral capsule&#xD;
Treatment A: Placebo was administered once daily</description>
          </group>
          <group group_id="O2">
            <title>400mg SPN-812</title>
            <description>400mg SPN-812 oral capsule&#xD;
Treatment B: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
          <group group_id="O3">
            <title>600mg SPN-812</title>
            <description>600mg SPN-812 oral capsule&#xD;
Treatment C: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of SPN-812 Assessed by the Hyperactivity/Impulsivity Subscale and the Inattention Subscale of the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)</title>
          <description>An additional secondary endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Hyperactivity/Impulsivity subscale score and Inattention subscale score at Week 7 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 DSM-5 symptoms of ADHD, including 9 items for the Hyperactivity/Impulsivity subscale and 9 items for the Inattention subscale. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). Each subscale score is calculated by adding the responses of all respective 9 items (range: 0-27; the higher the subscale score, the more severe the Hyperactivity/Impulsivity or Inattention symptoms). Lower change from baseline subscale scores (&lt;0) represent a better outcome.</description>
          <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hyperactivity/impulsivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.4" spread="0.69"/>
                    <measurement group_id="O2" value="-8.3" spread="0.68"/>
                    <measurement group_id="O3" value="-7.6" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inattention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.1" spread="0.76"/>
                    <measurement group_id="O2" value="-10.1" spread="0.75"/>
                    <measurement group_id="O3" value="-8.7" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to the Hyperactivity/Impulsivity subscale score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0484</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-1.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.97</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.8</ci_lower_limit>
            <ci_upper_limit>-0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to the Hyperactivity/Impulsivity subscale score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2084</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-1.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.96</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.1</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to the Inattention subscale score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0042</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-3.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.06</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.1</ci_lower_limit>
            <ci_upper_limit>-1.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to the Inattention subscale score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1392</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-1.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.06</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.6</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of SPN-812 Assessed by Conners 3 - Self Report Short Form</title>
        <description>An additional secondary endpoint was the change from baseline in the Conners 3rd Edition - Self Report Short Form (C3-SRS) Composite T score at Week 7 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3-SRS, which is only validated in children/adolescents 8-18 years of age, is comprised of 41 items with subsets of items related to five content scales: inattention, hyperactivity/impulsivity, learning problems, aggression and family relations. The subject rates himself/herself on the first 39 items of C3-SRS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently] based on past month; the last 2 items are fill-in-the-blank and do not contribute to the raw score(s). Raw scores are converted to T-scores. Lower change from baseline T-scores (&lt;0) represent a better outcome.</description>
        <time_frame>Baseline and Week 7 (End of Study)</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo oral capsule&#xD;
Treatment A: Placebo was administered once daily</description>
          </group>
          <group group_id="O2">
            <title>400mg SPN-812</title>
            <description>400mg SPN-812 oral capsule&#xD;
Treatment B: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
          <group group_id="O3">
            <title>600mg SPN-812</title>
            <description>600mg SPN-812 oral capsule&#xD;
Treatment C: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of SPN-812 Assessed by Conners 3 - Self Report Short Form</title>
          <description>An additional secondary endpoint was the change from baseline in the Conners 3rd Edition - Self Report Short Form (C3-SRS) Composite T score at Week 7 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3-SRS, which is only validated in children/adolescents 8-18 years of age, is comprised of 41 items with subsets of items related to five content scales: inattention, hyperactivity/impulsivity, learning problems, aggression and family relations. The subject rates himself/herself on the first 39 items of C3-SRS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently] based on past month; the last 2 items are fill-in-the-blank and do not contribute to the raw score(s). Raw scores are converted to T-scores. Lower change from baseline T-scores (&lt;0) represent a better outcome.</description>
          <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
          <units>T-score</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.4" spread="0.76"/>
                    <measurement group_id="O2" value="-5.4" spread="0.76"/>
                    <measurement group_id="O3" value="-6.6" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3810</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-0.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.07</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.0</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0432</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-2.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.08</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.3</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved&quot;]</title>
        <description>An additional secondary endpoint was the percentage of subjects who were &quot;improved&quot; by visit; &quot;improved&quot; was defined as a subject who had a Clinical Global Impression - Improvement (CGI-I) score of 1 = &quot;Very Much Improved&quot; or 2 = &quot;Much Improved&quot;. Values range from 0 to 100%. A higher percentage represents a greater number of subjects who were &quot;improved&quot;.</description>
        <time_frame>Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo oral capsule&#xD;
Treatment A: Placebo was administered once daily</description>
          </group>
          <group group_id="O2">
            <title>400mg SPN-812</title>
            <description>400mg SPN-812 oral capsule&#xD;
Treatment B: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
          <group group_id="O3">
            <title>600mg SPN-812</title>
            <description>600mg SPN-812 oral capsule&#xD;
Treatment C: SPN-812 was administered once daily and compared to Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved&quot;]</title>
          <description>An additional secondary endpoint was the percentage of subjects who were &quot;improved&quot; by visit; &quot;improved&quot; was defined as a subject who had a Clinical Global Impression - Improvement (CGI-I) score of 1 = &quot;Very Much Improved&quot; or 2 = &quot;Much Improved&quot;. Values range from 0 to 100%. A higher percentage represents a greater number of subjects who were &quot;improved&quot;.</description>
          <population>Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4"/>
                    <measurement group_id="O2" value="15.2"/>
                    <measurement group_id="O3" value="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.1"/>
                    <measurement group_id="O2" value="33.1"/>
                    <measurement group_id="O3" value="25.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7"/>
                    <measurement group_id="O2" value="47.2"/>
                    <measurement group_id="O3" value="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.5"/>
                    <measurement group_id="O2" value="46.1"/>
                    <measurement group_id="O3" value="39.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.4"/>
                    <measurement group_id="O2" value="48.2"/>
                    <measurement group_id="O3" value="45.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5"/>
                    <measurement group_id="O2" value="56.5"/>
                    <measurement group_id="O3" value="46.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.5"/>
                    <measurement group_id="O2" value="60.6"/>
                    <measurement group_id="O3" value="47.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to Week 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1433</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0114</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to Week 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0008</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to Week 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0197</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to Week 5</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0573</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to Week 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0105</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to Week 7</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0004</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to Week 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2573</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1650</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to Week 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0372</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to Week 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1711</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to Week 5</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1428</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to Week 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2148</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>This analysis pertains to Week 7</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0662</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 weeks</time_frame>
      <desc>Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo oral capsule&#xD;
Treatment A: Placebo was administered once daily</description>
        </group>
        <group group_id="E2">
          <title>400mg SPN-812</title>
          <description>400mg SPN-812 oral capsule&#xD;
Treatment B: SPN-812 was administered once daily and compared to Placebo</description>
        </group>
        <group group_id="E3">
          <title>600mg SPN-812</title>
          <description>600mg SPN-812 oral capsule&#xD;
Treatment C: SPN-812 was administered once daily and compared to Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="92" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="74" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="99"/>
              </event>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="100"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Joseph Hull, PhD, Associate Director Clinical Research</name_or_title>
      <organization>Supernus</organization>
      <phone>240-403-5324</phone>
      <email>jhull@supernus.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


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/NCT03247556
org study id: 812P304
nct id: NCT03247556
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the efficacy and safety of high doses of SPN-812 in adolescents
      (12-17 years old) with ADHD
This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group
      study to assess the efficacy and safety of SPN-812 as a monotherapy for the treatment of
      adolescents 12-17 years old with ADHD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)
time frame: Baseline and Week 7 (End of Study)
description: The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 7 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (<0) represent a better outcome.
measure: Effect of SPN-812 Assessed by Clinical Global Impression-Improvement (CGI-I) Scale
time frame: Week 7 (End of Study)
description: The first Key Secondary Endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 7 (End of Study). The CGI-I scale is a single item assessment of how much the patient's illness has improved or worsened relative to a baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point Likert scale from 1 to 7, where 1 = "very much improved" and 7 = "very much worse." Successful therapy is indicated by a lower overall score in subsequent testing.
measure: Effect of SPN-812 Assessed by Conners 3 - Parent Short Form (C3PS)
time frame: Baseline and Week 7 (End of Study)
description: The second Key Secondary Endpoint was the change from baseline in the Conners 3rd Edition - Parent Short Form (C3PS) Composite T-score at Week 7 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for the assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3PS is completed by a child's parent/guardian and is comprised of 45 items with subsets of items related to six content scales: inattention, hyperactivity/impulsivity, executive functioning, learning problems, defiance/aggression and peer relations. The parent rates his/her child on the first 43 items of the C3PS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently]) based on past month; the last 2 items are fill-in-the-blank. Raw scores are converted to T-scores. Lower change from baseline T-scores (<0) represent a better outcome.
measure: Effect of SPN-812 Assessed by Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
time frame: Baseline and Week 7 (End of Study)
description: The third Key Secondary Endpoint was the change from baseline in the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) Total Average score at Week 7 (End of Study). The WFIRS instrument evaluates ADHD-related functional impairment. The WFIRS-P is completed by the child's parent/guardian and is comprised of 50 items grouped into six domains: Family (10 items), School (10 items, includes learning [4 items] and behavior [6 items]), Life Skills (10 items), Child's Self-Concept (3 items), Social Activities (7 items), and Risky Activities (10 items). The parent/guardian rates each item on a 4-point Likert scale (0-3; where 0=never or not at all to 3= very often or very much) based on their child's behavior past month. A Total Average score was computed by calculating mean rating of all 50 items (ranging from 0 to 3, where a higher value represents more severe functional impairment). Lower change from baseline Total Average scores (<0) represent a better outcome.
measure: Effect of SPN-812 Assessed by 50% Responder Rate Per the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)
time frame: Week 7 (End of Study)
description: An additional secondary endpoint was the percentage of responders at Week 7 (End of Study). A responder was defined as a subject who had a 50% or greater reduction (improvement) in their change from baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 7 (End of Study). Values range from 0 to 100%. A higher percentage represents a greater number of responders.
measure: Effect of SPN-812 Assessed by Stress Index for Parents of Adolescents (SIPA)
time frame: Baseline and Week 7 (End of Study)
description: Another secondary endpoint was the change from baseline in the Stress Index for Parents of Adolescents (SIPA) Total score to Week 7 (End of Study). The SIPA is a 112-item screening/diagnostic instrument for parents of adolescents 11-19 years of age that identifies areas of stress in parent-adolescent interactions. Items 1-90 are rated on a 5-point Likert scale (where SD=Strongly Disagree, D=Disagree, NS=Not Sure, A=Agree, and SA=Strongly Agree) and yields a raw score for 3 Domains (Adolescent Domain, Parent Domain, and Adolescent-Parent Domain) that focus on a parent's perception of their child's personality and on the parent's characteristics and behaviors. The sum of the 3 Domain scores yields the Total (Parent Stress) score (range: 90-450; higher total scores indicate higher levels of stress). Lower change from baseline scores (<0) represent a better outcome
measure: Effect of SPN-812 Assessed by the Hyperactivity/Impulsivity Subscale and the Inattention Subscale of the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)
time frame: Baseline and Week 7 (End of Study)
description: An additional secondary endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Hyperactivity/Impulsivity subscale score and Inattention subscale score at Week 7 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 DSM-5 symptoms of ADHD, including 9 items for the Hyperactivity/Impulsivity subscale and 9 items for the Inattention subscale. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). Each subscale score is calculated by adding the responses of all respective 9 items (range: 0-27; the higher the subscale score, the more severe the Hyperactivity/Impulsivity or Inattention symptoms). Lower change from baseline subscale scores (<0) represent a better outcome.
measure: Effect of SPN-812 Assessed by Conners 3 - Self Report Short Form
time frame: Baseline and Week 7 (End of Study)
description: An additional secondary endpoint was the change from baseline in the Conners 3rd Edition - Self Report Short Form (C3-SRS) Composite T score at Week 7 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3-SRS, which is only validated in children/adolescents 8-18 years of age, is comprised of 41 items with subsets of items related to five content scales: inattention, hyperactivity/impulsivity, learning problems, aggression and family relations. The subject rates himself/herself on the first 39 items of C3-SRS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently] based on past month; the last 2 items are fill-in-the-blank and do not contribute to the raw score(s). Raw scores are converted to T-scores. Lower change from baseline T-scores (<0) represent a better outcome.
measure: Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"]
time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7
description: An additional secondary endpoint was the percentage of subjects who were "improved" by visit; "improved" was defined as a subject who had a Clinical Global Impression - Improvement (CGI-I) score of 1 = "Very Much Improved" or 2 = "Much Improved". Values range from 0 to 100%. A higher percentage represents a greater number of subjects who were "improved".
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, qd, oral capsule
arm group label: 400mg SPN-812
arm group type: Experimental
description: 400mg SPN-812, qd, oral capsule
arm group label: 600mg SPN-812
arm group type: Experimental
description: 600mg SPN-812, qd, oral capsule
intervention type: Drug
intervention name: Placebo
description: Placebo was administered once daily
arm group label: Placebo
other name: PBO
intervention type: Drug
intervention name: 400mg SPN-812
description: 400mg SPN-812 was administered once daily and compared to Placebo
arm group label: 400mg SPN-812
other name: SPN-812
intervention type: Drug
intervention name: 600mg SPN-812
description: 600mg SPN-812 was administered once daily and compared to Placebo
arm group label: 600mg SPN-812
other name: SPN-812
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Jonathan Rubin, MD
role: Study Director
affiliation: Supernus Pharmaceuticals, Inc.
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country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 