<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/NCT03231800</url>
  </required_header>
  <id_info>
    <org_study_id>SEP-360-311</org_study_id>
    <nct_id>NCT03231800</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.</brief_title>
  <official_title>Dasotraline (2mg) in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD): A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of Efficacy and Safety in a Laboratory Classroom Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sumitomo Pharma America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sumitomo Pharma America, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A study to evaluate the efficacy and safety of dasotraline in children 6 to 12 years of age&#xD;
      with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety&#xD;
      study in children with ADHD in a laboratory classroom setting. The study will be comprised of&#xD;
      3 periods: Screening (up to 35 days) including a 3 - 5 day ADHD medication washout prior to&#xD;
      Day -1; Double-blind randomized treatment with either dasotraline (2 mg/day) or placebo for&#xD;
      14 days; and a final safety evaluation 7 days after last dose. Prior to the start of&#xD;
      treatment (Day 1) and following the conclusion of the double-blind period (Day 15), subjects&#xD;
      will undergo a full-day laboratory classroom evaluation in cohorts of up to 18 subjects. Each&#xD;
      laboratory classroom day will include seven 30-minute simulated classroom sessions where&#xD;
      trained observers will assess subjects using the Swanson, Kotkin, Agler, M-Flynn, and Pelham&#xD;
      (SKAMP) Scale. In addition during each classroom session, a 10-minute math test (Permanent&#xD;
      Product Measure of Performance [PERMP]) will be administered to evaluate sustained attention&#xD;
      and effort. Seven (± 2) days after the last dose of study drug, subjects will return to the&#xD;
      clinic and complete safety assessments.&#xD;
&#xD;
      This study is designed to test the superiority of dasotraline 2 mg/day against placebo based&#xD;
      on Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP)-Combined score in pediatric&#xD;
      subjects aged 6-12 years with ADHD who weigh ≤ 30 kg&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Actual">March 15, 2019</completion_date>
  <primary_completion_date type="Actual">March 15, 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>
    <intervention_model_description>This is a randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study in children with ADHD in a laboratory classroom setting</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline at Day 15 in , ADHD Symptoms as Measured by Mean Swanson,Kotkin,Agler,M-Flynn, Pelham Rating Scale(SKAMP)-Combined Score Obtained From an Average of the 7 Assessments Collected Across the 12-hour Classroom Day(12 to 24 Hours Postdose)</measure>
    <time_frame>Baseline to Day 15</time_frame>
    <description>The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The combined scores for the SKAMP are obtained by summing the values of all 13 items in the assessment. The range of SKAMP combined score is 0-78, with higher values represent a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)Attention Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)</measure>
    <time_frame>Baseline to Day 15</time_frame>
    <description>The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The Attention Subscale scores for the SKAMP are obtained by summing the values of Items 1-4 in the assessment. The range of SKAMP Attention Subscale score is 0-24, with higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Deportment Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)</measure>
    <time_frame>Baseline to Day 15</time_frame>
    <description>The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The Deportment Subscale scores for the SKAMP are obtained by summing the values of Items 5-8 in the assessment. The range of SKAMP Deportment Subscale score is 0-24, with higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline at Day 15 in Mean Permanent Product Measure of Performance (PERMP)-Attempted Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)</measure>
    <time_frame>Baseline to Day 15</time_frame>
    <description>The Permanent Product Measure of Performance (PERMP) is a math test consisting of 400 problems. Both attempted problems and correct problems are assessed. Subjects are to complete as many problems as possible in 10 minutes. Performance is measured by the number of math problems attempted and the number of math problems correctly completed. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline at Day 15 in Mean Permanent Product Measure of Performance (PERMP)-Correct Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)</measure>
    <time_frame>Baseline to Day 15</time_frame>
    <description>The Permanent Product Measure of Performance (PERMP) is a math test consisting of 400 problems. Both attempted problems and correct problems are assessed. Subjects are to complete as many problems as possible in 10 minutes. Performance is measured by the number of math problems attempted and the number of math problems correctly completed. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Attention-Deficit Hyperactivity Disorder (ADHD)</condition>
  <arm_group>
    <arm_group_label>Dasotraline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dasotraline capsule 2mg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsule</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dasotraline</intervention_name>
    <description>dasotraline 2mg capsule once daily</description>
    <arm_group_label>Dasotraline</arm_group_label>
    <other_name>SEP-225289</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo capsule once daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is 6 - 12 years old, inclusive at screening and randomization.&#xD;
&#xD;
          2. Subject weighs ≤ 30 kg at the time of screening.&#xD;
&#xD;
          3. At least one of the subject's parents/legal guardians must give written informed&#xD;
             consent, including privacy authorization, prior to study participation. The subject&#xD;
             will provide informed assent prior to study participation.&#xD;
&#xD;
          4. Subject meets Diagnostic and Statistical Manual of Mental Disorders Fifth Edition&#xD;
             (DSM-5) criteria for a primary diagnosis of ADHD (inattentive, hyperactive, or&#xD;
             combined presentation) at screening established by a comprehensive psychiatric&#xD;
             evaluation that reviews DSM-5 criteria and confirmed using the Schedule for Affective&#xD;
             Disorders and Schizophrenia for School-Age Children-Present and Lifetime version&#xD;
             (K-SADS-PL) at screening.&#xD;
&#xD;
          5. Subject is currently either untreated for ADHD or receiving a treatment regimen of a&#xD;
             stimulant medication prescribed as monotherapy (i.e., methylphenidate, mixed&#xD;
             amphetamine salts, lisdexamphetamine, or dextroamphetamine) within the approved&#xD;
             labeled dose range for ADHD..&#xD;
&#xD;
          6. In the opinion of the investigator, the subject is not treatment refractory.&#xD;
&#xD;
          7. Any subject not receiving ADHD medication at screening must display clinically&#xD;
             significant ADHD symptoms, as measured by an ADHD-RS-IV score ≥ 26 at screening and&#xD;
             Day -7.&#xD;
&#xD;
          8. For any subject receiving monotherapy stimulant treatment for ADHD, that treatment&#xD;
             must be well tolerated and clinically effective based on clinical assessment and&#xD;
             informant interview, as well as, review of available medical records. Note: The ADHD&#xD;
             Rating Scale Version IV - Home Version (modified for investigator administration)&#xD;
             (ADHD RS IV HV) will be administered at Screening by the investigator to inform&#xD;
             clinical evaluation.&#xD;
&#xD;
          9. Subject is male or a non-pregnant, non-lactating female.&#xD;
&#xD;
         10. Subject, if female, must not be pregnant or breastfeeding, and if ≥ 8 years of age&#xD;
             must have a negative serum pregnancy test at screening.&#xD;
&#xD;
         11. Female subjects of childbearing potential and male subjects with female partners of&#xD;
             childbearing potential must practice true abstinence (consistent with lifestyle) and&#xD;
             must agree to remain abstinent or agree to use an effective and medically acceptable&#xD;
             form of birth control, from the time of informed consent/assent to at least 14 days&#xD;
             after the last dose of the study drug has been taken.&#xD;
&#xD;
         12. Subject must be in general good health (defined as the absence of any clinically&#xD;
             relevant abnormalities as determined by the investigator) based on screening physical&#xD;
             and neurological examinations, medical history, and clinical laboratory values&#xD;
             (hematology, chemistry, and urinalysis). Note: If any of the hematology, chemistry, or&#xD;
             urinalysis results are not within the laboratory's reference range, then the subject&#xD;
             can be included only if the investigator determines the deviations to be not&#xD;
             clinically relevant.&#xD;
&#xD;
         13. Subject is within the 3rd to 97th percentile for gender specific weight-for-age from&#xD;
             the Centers for Disease Control and Prevention (CDC) growth charts&#xD;
&#xD;
         14. Subject must report a history of being able to swallow capsules.&#xD;
&#xD;
         15. Subject and subject's parent/legal guardian must be able to fully comprehend the&#xD;
             informed consent/assent forms, understand and be willing and able to comply with all&#xD;
             study procedures and visit schedule, and be able to communicate satisfactorily with&#xD;
             the investigator and study coordinator.&#xD;
&#xD;
         16. Subject, on Day -1, has evidence of clinically significant ADHD symptoms as measured&#xD;
             by an ADHD RS IV HV total score ≥ 26. If subject has been receiving stimulant&#xD;
             pharmacotherapy for ADHD the ADHD RS-IV should be administered following a minimum 72&#xD;
             hour washout from prior ADHD medication treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject or parent/legal guardian has commitments during the study that would interfere&#xD;
             with attending study visits.&#xD;
&#xD;
          2. Subject is currently being treated for ADHD with a non-stimulant product, or has been&#xD;
             treated with a non-stimulant product in the 4 weeks prior to the start of screening.&#xD;
&#xD;
          3. Subject has failed 2 adequate courses (dose and duration) of stimulant or&#xD;
             non-stimulant treatment for ADHD.&#xD;
&#xD;
          4. Subject is considered treatment refractory, as judged by the investigator.&#xD;
&#xD;
          5. Subject currently has a diagnosis of asthma that has required daily treatment with&#xD;
             bronchodilators or nebulizer treatments in the 30 days prior to screening and/or who&#xD;
             may require daily treatments with these agents over the course of the trial.&#xD;
             Intermittent use of bronchodilators is not exclusionary. Subjects who have a history&#xD;
             of requiring persistent asthma treatment should be discussed with the medical monitor&#xD;
             prior to randomization.&#xD;
&#xD;
          6. Subject has any clinically significant unstable medical abnormality, chronic disease,&#xD;
             or a history of a clinically significant abnormality of the cardiovascular,&#xD;
             gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of&#xD;
             a condition (eg, malabsorption, gastrointestinal surgery) that may interfere with drug&#xD;
             absorption, distribution, metabolism, or excretion. Note: Active medical conditions&#xD;
             that are minor or well-controlled are not exclusionary if they do not affect risk to&#xD;
             the subject or the study results. In cases in which the impact of the condition upon&#xD;
             risk to the subject or study results is unclear, the medical monitor should be&#xD;
             consulted. Any subject with a known cardiovascular disease or condition (even if&#xD;
             controlled) must be discussed with the medical monitor during screening.&#xD;
&#xD;
          7. Subject has a history or presence of abnormal ECGs, which in the investigator's&#xD;
             opinion is clinically significant. Screening site ECGs will be centrally over-read,&#xD;
             and eligibility will be determined by the investigator based on the results of the&#xD;
             over-read report.&#xD;
&#xD;
          8. Subject has any diagnosis of bipolar I or II disorder, major depressive disorder,&#xD;
             conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism&#xD;
             spectrum disorder, disruptive mood dysregulation disorder (DMDD), intellectual&#xD;
             disability, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or&#xD;
             behavioral disturbances. Note: Subjects with oppositional defiant disorder (ODD) are&#xD;
             permitted to enroll in the study as long as ODD is not the primary focus of treatment.&#xD;
&#xD;
          9. Subject has a first-degree relative (biological parent or sibling) with a history of&#xD;
             schizophrenia, schizoaffective disorder, bipolar I disorder, or bipolar II disorder.&#xD;
&#xD;
         10. Subject has generalized anxiety disorder or panic disorder that has been the primary&#xD;
             focus of treatment at any time during the 12 months prior to screening or that has&#xD;
             required pharmacotherapy any time during the 6 months prior to screening.&#xD;
&#xD;
         11. Subject has evidence of any chronic disease of the central nervous system (CNS) such&#xD;
             as tumors, inflammation, seizure disorder, vascular disorder, potential CNS related&#xD;
             disorders that might occur in childhood (eg, Duchenne Muscular dystrophy, myasthenia&#xD;
             gravis, or other neurologic or serious neuromuscular disorders)&#xD;
&#xD;
         12. Subjects with a history of persistent neurological symptoms attributable to serious&#xD;
             head injury.&#xD;
&#xD;
         13. History of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is&#xD;
             exclusionary.&#xD;
&#xD;
         14. Subjects taking anticonvulsants for seizure control currently or within the past 2&#xD;
             years are not eligible for study participation.&#xD;
&#xD;
         15. Subject has uncontrolled thyroid disorder as evidenced by thyroid stimulating hormone&#xD;
             (TSH) ≤ 0.8 x the lower limit of normal (LLN) or ≥ 1.25 x the upper limit of normal&#xD;
             (ULN) for the reference laboratory&#xD;
&#xD;
         16. Subject answers &quot;yes&quot; to &quot;Suicidal Ideation&quot; item 4 (active suicidal ideation with&#xD;
             some intent to act, without specific plan) or item 5 (active suicidal ideation with&#xD;
             specific plan and intent) for any lifetime history on the C-SSRS Children's&#xD;
             Lifetime/Recent assessment at screening.&#xD;
&#xD;
         17. Subject has any history of attempted suicide or clinically significant suicidal&#xD;
             ideation, in the opinion of the investigator.&#xD;
&#xD;
         18. Subject has a history of severe allergies to more than 1 class of medication or&#xD;
             multiple adverse drug reactions or has a history of allergic reaction or has a known&#xD;
             or suspected sensitivity to any substance that is contained in the study drug&#xD;
             formulations&#xD;
&#xD;
         19. Subject has history of intolerance (safety) or lack of efficacy to stimulants.&#xD;
&#xD;
         20. Subject has taken any antipsychotic medication within 6 months prior to screening.&#xD;
&#xD;
         21. Subject has taken any herbal and/or complementary treatments, eg, St. John's Wort,&#xD;
             within 6 months prior to Day 1.&#xD;
&#xD;
         22. Subject has taken any antidepressant medication (eg, bupropion, selective serotonin&#xD;
             reuptake inhibitor [SSRI]/ serotonin norepinephrine reuptake inhibitor [SNRI],&#xD;
             tricyclic, etc) within 6 months prior to Day 1.&#xD;
&#xD;
         23. Subject has ever taken any monoamine oxidase [MAO] inhibitor at any time.&#xD;
&#xD;
         24. Subject is currently undergoing ongoing or newly initiated Cognitive Behavioral&#xD;
             Therapy (CBT) for the treatment of ADHD; behavioral therapies, including school based&#xD;
             interventions that were initiated less than one month prior to screening; or,&#xD;
             behavioral therapy that in the opinion of the investigator would interfere with the&#xD;
             subject's ability to participate for the duration of the study. School based&#xD;
             interventions that have been in place for more than one month prior to screening will&#xD;
             be allowed. Note: Unavoidable changes in school-based interventions that occur during&#xD;
             study participation will not be exclusionary, but should be documented by the&#xD;
             investigator, to the extent possible. Subjects should not be enrolled who, in the&#xD;
             judgment of the investigator, are expected to start substantially different or more&#xD;
             intensive course of behavioral therapy over the duration of their participation in the&#xD;
             study.&#xD;
&#xD;
         25. Subject or subject's family anticipates a move outside the geographic range of&#xD;
             investigative site during the study period, or plans extended travel inconsistent with&#xD;
             the recommended visit interval during study duration.&#xD;
&#xD;
         26. Subject has history of, or current, malignancy other than non-melanomatous skin&#xD;
             cancer.&#xD;
&#xD;
         27. Subject has history of positive test for Hepatitis B surface antigen or Hepatitis C&#xD;
             antibody.&#xD;
&#xD;
         28. Subject is known to have tested positive for human immunodeficiency virus (HIV).&#xD;
&#xD;
         29. Subject has participated in a classroom study within 6 months prior to the start of&#xD;
             screening or has participated in any other clinical study with an investigational&#xD;
             drug/product within 90 days prior to the start of screening or is currently&#xD;
             participating in another clinical trial.&#xD;
&#xD;
         30. Subject shows evidence of substance or alcohol use or is currently using tobacco or&#xD;
             other nicotine-containing products, or has a positive urine drug screen (UDS) at&#xD;
             screening. Note: Subjects with a positive UDS may be allowed to continue in the study,&#xD;
             provided that the investigator determines that the positive test is as a result of&#xD;
             taking medications as prescribed after consultation with the medical monitor.&#xD;
&#xD;
         31. Subject is taking any disallowed medications for chronic treatment.&#xD;
&#xD;
         32. Subject has previously been enrolled in a clinical trial of dasotraline (SEP-225289).&#xD;
&#xD;
         33. Subject's parent/legal guardian is an investigational site staff member or the&#xD;
             relative of an investigational site staff member.&#xD;
&#xD;
         34. Subject is, in the opinion of the investigator, unsuitable in any other way to&#xD;
             participate in this study.&#xD;
&#xD;
         35. Subject's sibling or family member living in the same household is participating in&#xD;
             the same laboratory classroom cohort for this study.&#xD;
&#xD;
         36. Subject is unable to perform at the basic level of the standardized math test as&#xD;
             defined in the laboratory classroom manual.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CNS Mecdical Director</last_name>
    <role>Study Chair</role>
    <affiliation>Sunovion Pharmacetuicals Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Avida Inc</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qps-Mra, Llc</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Shore Psychiatric Services PC</name>
      <address>
        <city>Hingham</city>
        <state>Massachusetts</state>
        <zip>02043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Psychiatry and Behavioral Medicine, Inc</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bayou City Research, Ltd</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ericksen Reasearch and 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 2020</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <results_first_submitted>June 4, 2020</results_first_submitted>
  <results_first_submitted_qc>June 4, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 24, 2020</results_first_posted>
  <disposition_first_submitted>March 2, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>March 2, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 4, 2020</disposition_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Attention-Deficit Hyperactivity Disorder (ADHD)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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>November 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03231800/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>March 26, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03231800/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 capsule</description>
        </group>
        <group group_id="P2">
          <title>Dasotraline</title>
          <description>Dasotraline capsule 2mg/day</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>reason not provided</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo capsule</description>
        </group>
        <group group_id="B2">
          <title>Dasotraline</title>
          <description>Dasotraline capsule 2mg/day</description>
        </group>
        <group group_id="B3">
          <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="47"/>
            <count group_id="B2" value="47"/>
            <count group_id="B3" value="94"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="7.4" spread="1.17"/>
                    <measurement group_id="B2" value="7.5" spread="1.21"/>
                    <measurement group_id="B3" value="7.5" spread="1.19"/>
                  </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="13"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="63"/>
                  </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="14"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="69"/>
                  </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_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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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_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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height (cm)</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="125.1" spread="8.37"/>
                    <measurement group_id="B2" value="127.3" spread="6.95"/>
                    <measurement group_id="B3" value="126.2" spread="7.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight (kg)</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.9" spread="3.35"/>
                    <measurement group_id="B2" value="25.6" spread="3.8"/>
                    <measurement group_id="B3" value="25.3" spread="3.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI (kg/m^2)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.92" spread="1.185"/>
                    <measurement group_id="B2" value="15.68" spread="1.261"/>
                    <measurement group_id="B3" value="15.8" spread="1.223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Averaged Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale - CS</title>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.23" spread="12.15"/>
                    <measurement group_id="B2" value="24.61" spread="13.362"/>
                    <measurement group_id="B3" value="25.42" spread="12.727"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Averaged Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale ( - Attention Subscale Score</title>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.07" spread="3.323"/>
                    <measurement group_id="B2" value="4.74" spread="3.562"/>
                    <measurement group_id="B3" value="4.91" spread="3.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Averaged Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale ( - Deportment Subscale Score</title>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.7" spread="4.729"/>
                    <measurement group_id="B2" value="6.4" spread="4.807"/>
                    <measurement group_id="B3" value="6.55" spread="4.745"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Averaged Permanent Product Measure of Performance (PERMP) - Problems Attempted</title>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.09" spread="36.173"/>
                    <measurement group_id="B2" value="79.62" spread="47.008"/>
                    <measurement group_id="B3" value="73.85" spread="42.116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Averaged Permanent Product Measure of Performance (PERMP)- Problems Correct</title>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.36" spread="37.26"/>
                    <measurement group_id="B2" value="76.41" spread="47.42"/>
                    <measurement group_id="B3" value="68.39" spread="43.173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline at Day 15 in , ADHD Symptoms as Measured by Mean Swanson,Kotkin,Agler,M-Flynn, Pelham Rating Scale(SKAMP)-Combined Score Obtained From an Average of the 7 Assessments Collected Across the 12-hour Classroom Day(12 to 24 Hours Postdose)</title>
        <description>The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The combined scores for the SKAMP are obtained by summing the values of all 13 items in the assessment. The range of SKAMP combined score is 0-78, with higher values represent a worse outcome.</description>
        <time_frame>Baseline to Day 15</time_frame>
        <population>intent to treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule</description>
          </group>
          <group group_id="O2">
            <title>Dasotraline</title>
            <description>Dasotraline capsule 2mg/day</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline at Day 15 in , ADHD Symptoms as Measured by Mean Swanson,Kotkin,Agler,M-Flynn, Pelham Rating Scale(SKAMP)-Combined Score Obtained From an Average of the 7 Assessments Collected Across the 12-hour Classroom Day(12 to 24 Hours Postdose)</title>
          <description>The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The combined scores for the SKAMP are obtained by summing the values of all 13 items in the assessment. The range of SKAMP combined score is 0-78, with higher values represent a worse outcome.</description>
          <population>intent to treat population</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="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.57" spread="0.773"/>
                    <measurement group_id="O2" value="-3.67" spread="0.775"/>
                  </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>Least squares means, SEs, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), mean SKAMP-CS at baseline, and site as fixed effects.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.059</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.351</ci_lower_limit>
            <ci_upper_limit>-3.137</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)Attention Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)</title>
        <description>The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The Attention Subscale scores for the SKAMP are obtained by summing the values of Items 1-4 in the assessment. The range of SKAMP Attention Subscale score is 0-24, with higher values represent a worse outcome.</description>
        <time_frame>Baseline to Day 15</time_frame>
        <population>intent to treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule</description>
          </group>
          <group group_id="O2">
            <title>Dasotraline</title>
            <description>Dasotraline capsule 2mg/day</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)Attention Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)</title>
          <description>The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The Attention Subscale scores for the SKAMP are obtained by summing the values of Items 1-4 in the assessment. The range of SKAMP Attention Subscale score is 0-24, with higher values represent a worse outcome.</description>
          <population>intent to treat population</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="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" spread="0.293"/>
                    <measurement group_id="O2" value="-0.27" spread="0.294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Deportment Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)</title>
        <description>The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The Deportment Subscale scores for the SKAMP are obtained by summing the values of Items 5-8 in the assessment. The range of SKAMP Deportment Subscale score is 0-24, with higher values represent a worse outcome.</description>
        <time_frame>Baseline to Day 15</time_frame>
        <population>intent to treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule</description>
          </group>
          <group group_id="O2">
            <title>Dasotraline</title>
            <description>Dasotraline capsule 2mg/day</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Deportment Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)</title>
          <description>The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The Deportment Subscale scores for the SKAMP are obtained by summing the values of Items 5-8 in the assessment. The range of SKAMP Deportment Subscale score is 0-24, with higher values represent a worse outcome.</description>
          <population>intent to treat population</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="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="0.304"/>
                    <measurement group_id="O2" value="-1.78" spread="0.306"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline at Day 15 in Mean Permanent Product Measure of Performance (PERMP)-Attempted Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)</title>
        <description>The Permanent Product Measure of Performance (PERMP) is a math test consisting of 400 problems. Both attempted problems and correct problems are assessed. Subjects are to complete as many problems as possible in 10 minutes. Performance is measured by the number of math problems attempted and the number of math problems correctly completed. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.</description>
        <time_frame>Baseline to Day 15</time_frame>
        <population>intent to treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule</description>
          </group>
          <group group_id="O2">
            <title>Dasotraline</title>
            <description>Dasotraline capsule 2mg/day</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline at Day 15 in Mean Permanent Product Measure of Performance (PERMP)-Attempted Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)</title>
          <description>The Permanent Product Measure of Performance (PERMP) is a math test consisting of 400 problems. Both attempted problems and correct problems are assessed. Subjects are to complete as many problems as possible in 10 minutes. Performance is measured by the number of math problems attempted and the number of math problems correctly completed. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.</description>
          <population>intent to treat population</population>
          <units>problems</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="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.51" spread="4.128"/>
                    <measurement group_id="O2" value="17.37" spread="4.074"/>
                  </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>0.016</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>13.86</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.612</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.694</ci_lower_limit>
            <ci_upper_limit>25.017</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline at Day 15 in Mean Permanent Product Measure of Performance (PERMP)-Correct Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)</title>
        <description>The Permanent Product Measure of Performance (PERMP) is a math test consisting of 400 problems. Both attempted problems and correct problems are assessed. Subjects are to complete as many problems as possible in 10 minutes. Performance is measured by the number of math problems attempted and the number of math problems correctly completed. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.</description>
        <time_frame>Baseline to Day 15</time_frame>
        <population>intent to treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule</description>
          </group>
          <group group_id="O2">
            <title>Dasotraline</title>
            <description>Dasotraline capsule 2mg/day</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline at Day 15 in Mean Permanent Product Measure of Performance (PERMP)-Correct Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)</title>
          <description>The Permanent Product Measure of Performance (PERMP) is a math test consisting of 400 problems. Both attempted problems and correct problems are assessed. Subjects are to complete as many problems as possible in 10 minutes. Performance is measured by the number of math problems attempted and the number of math problems correctly completed. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.</description>
          <population>intent to treat population</population>
          <units>problems</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="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.47" spread="4.047"/>
                    <measurement group_id="O2" value="17.53" spread="3.979"/>
                  </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>0.031</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>12.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.508</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.105</ci_lower_limit>
            <ci_upper_limit>23.017</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo capsule</description>
        </group>
        <group group_id="E2">
          <title>Dasotraline</title>
          <description>Dasotraline capsule 2mg/day</description>
        </group>
      </group_list>
      <serious_events>
        <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="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</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="2" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="47"/>
              </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>
      <restrictive_agreement>In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>CNS Medical Director</name_or_title>
      <organization>Sunovion Pharmaceuticals Inc.</organization>
      <phone>1-866-503-6351</phone>
      <email>ClinicalTrialDisclosure@sunovion.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/NCT03231800
org study id: SEP-360-311
nct id: NCT03231800
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A study to evaluate the efficacy and safety of dasotraline in children 6 to 12 years of age
      with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.
This is a randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety
      study in children with ADHD in a laboratory classroom setting. The study will be comprised of
      3 periods: Screening (up to 35 days) including a 3 - 5 day ADHD medication washout prior to
      Day -1; Double-blind randomized treatment with either dasotraline (2 mg/day) or placebo for
      14 days; and a final safety evaluation 7 days after last dose. Prior to the start of
      treatment (Day 1) and following the conclusion of the double-blind period (Day 15), subjects
      will undergo a full-day laboratory classroom evaluation in cohorts of up to 18 subjects. Each
      laboratory classroom day will include seven 30-minute simulated classroom sessions where
      trained observers will assess subjects using the Swanson, Kotkin, Agler, M-Flynn, and Pelham
      (SKAMP) Scale. In addition during each classroom session, a 10-minute math test (Permanent
      Product Measure of Performance [PERMP]) will be administered to evaluate sustained attention
      and effort. Seven (± 2) days after the last dose of study drug, subjects will return to the
      clinic and complete safety assessments.

      This study is designed to test the superiority of dasotraline 2 mg/day against placebo based
      on Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP)-Combined score in pediatric
      subjects aged 6-12 years with ADHD who weigh ≤ 30 kg
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study in children with ADHD in a laboratory classroom setting
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double Blind
measure: Change From Baseline at Day 15 in , ADHD Symptoms as Measured by Mean Swanson,Kotkin,Agler,M-Flynn, Pelham Rating Scale(SKAMP)-Combined Score Obtained From an Average of the 7 Assessments Collected Across the 12-hour Classroom Day(12 to 24 Hours Postdose)
time frame: Baseline to Day 15
description: The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The combined scores for the SKAMP are obtained by summing the values of all 13 items in the assessment. The range of SKAMP combined score is 0-78, with higher values represent a worse outcome.
measure: Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)Attention Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)
time frame: Baseline to Day 15
description: The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The Attention Subscale scores for the SKAMP are obtained by summing the values of Items 1-4 in the assessment. The range of SKAMP Attention Subscale score is 0-24, with higher values represent a worse outcome.
measure: Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Deportment Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)
time frame: Baseline to Day 15
description: The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The Deportment Subscale scores for the SKAMP are obtained by summing the values of Items 5-8 in the assessment. The range of SKAMP Deportment Subscale score is 0-24, with higher values represent a worse outcome.
measure: Change From Baseline at Day 15 in Mean Permanent Product Measure of Performance (PERMP)-Attempted Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)
time frame: Baseline to Day 15
description: The Permanent Product Measure of Performance (PERMP) is a math test consisting of 400 problems. Both attempted problems and correct problems are assessed. Subjects are to complete as many problems as possible in 10 minutes. Performance is measured by the number of math problems attempted and the number of math problems correctly completed. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.
measure: Change From Baseline at Day 15 in Mean Permanent Product Measure of Performance (PERMP)-Correct Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)
time frame: Baseline to Day 15
description: The Permanent Product Measure of Performance (PERMP) is a math test consisting of 400 problems. Both attempted problems and correct problems are assessed. Subjects are to complete as many problems as possible in 10 minutes. Performance is measured by the number of math problems attempted and the number of math problems correctly completed. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.
arm group label: Dasotraline
arm group type: Experimental
description: Dasotraline capsule 2mg/day
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsule
intervention type: Drug
intervention name: dasotraline
description: dasotraline 2mg capsule once daily
arm group label: Dasotraline
other name: SEP-225289
intervention type: Drug
intervention name: Placebo
description: Placebo capsule once daily
arm group label: Placebo
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: CNS Mecdical Director
role: Study Chair
affiliation: Sunovion Pharmacetuicals Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 