<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/NCT01711021</url>
  </required_header>
  <id_info>
    <org_study_id>N25-006</org_study_id>
    <nct_id>NCT01711021</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Safety &amp; Efficacy of d-Amphetamine Transdermal System vs Placebo in Children &amp; Adolescents With ADHD</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Crossover, Laboratory Classroom Study to Evaluate the Safety and Efficacy of d-Amphetamine Transdermal Drug Delivery System (d-ATS) Compared to Placebo in Children and Adolescents With ADHD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Noven Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Noven Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate safety and efficacy of d-Amphetamine Transdermal System for the&#xD;
      treatment of Attention Deficit Hyperactivity Disorder in children and adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will consist of a four-week screening period, a 3-day wash-out period (if&#xD;
      applicable), a five-week open-label, step-wise dose optimization period and two-week double&#xD;
      blind randomized crossover treatment period with weekly classroom assessments and a safety&#xD;
      follow-up by telephone 7 - 10 days after last dose of study drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) total score</measure>
    <time_frame>Pre-dose through all post-dose time points up to 12 hours post-dose (3 hours post-removal)</time_frame>
    <description>The SKAMP total score comprises all 13 items. The SKAMP was designed for independent observers to rate 13 items representing 2 factors of classroom behavior: attention (SKAMP-A) and deportment (SKAMP-D), as well as quality of work. Items are specific to place (classroom setting) and time (during a typical classroom period), and the scale is used to assess multiple ratings taken within a day.&#xD;
The SKAMP-D subscale evaluates deportment, including interacting with other children, interacting with adults, remaining quiet according to classroom rules, and staying seated according to classroom rules. The SKAMP-A subscale is a measure of attention and evaluates getting started on assignments, sticking with tasks, attending to an activity, and making activity transitions. The SKAMP quality of work subscale includes 3 items: completing assigned work, performing work accurately, and being careful and neat while writing or drawing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the onset of clinical effect for the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) total score</measure>
    <time_frame>Onset of efficacy defined as the time of the first assessment time showing statistical significance between d-ATS and placebo: 2 hours post-dose</time_frame>
    <description>The SKAMP total score comprises all 13 items. The SKAMP was designed for independent observers to rate 13 items representing 2 factors of classroom behavior: attention (SKAMP-A) and deportment (SKAMP-D), as well as quality of work. Items are specific to place (classroom setting) and time (during a typical classroom period), and the scale is used to assess multiple ratings taken within a day.&#xD;
The SKAMP-D subscale evaluates deportment, including interacting with other children, interacting with adults, remaining quiet according to classroom rules, and staying seated according to classroom rules. The SKAMP-A subscale is a measure of attention and evaluates getting started on assignments, sticking with tasks, attending to an activity, and making activity transitions. The SKAMP quality of work subscale includes 3 items: completing assigned work, performing work accurately, and being careful and neat while writing or drawing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the duration of clinical effect for the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) total score</measure>
    <time_frame>Double-blind Week 6 and Week 7: Duration of Effect from onset (2 hours) and up to 12 hours post-dose (p&lt;0.001)</time_frame>
    <description>The SKAMP total score comprises all 13 items. The SKAMP was designed for independent observers to rate 13 items representing 2 factors of classroom behavior: attention (SKAMP-A) and deportment (SKAMP-D), as well as quality of work. Items are specific to place (classroom setting) and time (during a typical classroom period), and the scale is used to assess multiple ratings taken within a day.&#xD;
The SKAMP-D subscale evaluates deportment, including interacting with other children, interacting with adults, remaining quiet according to classroom rules, and staying seated according to classroom rules. The SKAMP-A subscale is a measure of attention and evaluates getting started on assignments, sticking with tasks, attending to an activity, and making activity transitions. The SKAMP quality of work subscale includes 3 items: completing assigned work, performing work accurately, and being careful and neat while writing or drawing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Permanent Product Measure of Performance (PERMP) scores</measure>
    <time_frame>1,2, 3, 4.5,6,7,9,10 and 12 hours post-dose on combined double blind period (week 6 and week 7)</time_frame>
    <description>To assess efficacy of d-ATS compared to placebo as measured by the PERMP-C (number of correct answers) and PERMP-A (number of attempted answers) score. The PERMP is an age-adjusted written math test, of 10 minutes' duration administered at multiple time points. Subjects are given 5 pages of 80 math problems (400 total problems) and are instructed to work at their desks and to complete as many problems as possible in 10 minutes. Performance is measured as the number of problems attempted (PERMP-A) and the number of problems worked correctly (PERMP-C).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the clinician-rated scale of ADHD symptoms based on DSM-IV-TR criteria (ADHD-RS-IV).</measure>
    <time_frame>Combined Week 6 (visit 6) and Week 7 (visit 7) in the Double-Blind Cross-Over period</time_frame>
    <description>The ADHD-RS-IV is based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria to assess efficacy of d-ATS compared to placebo. The ADHD-RS-IV scale was developed to measure the behaviors of children with ADHD, and it consists of 18 items designed to reflect current symptomatology of ADHD based on DSM-IV criteria. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0 to 54.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Conners Parent Rating Scale Revised Short Form (CPRS-R:S) total scores</measure>
    <time_frame>Baseline to combined week 6 and 7</time_frame>
    <description>The CPRS-R:S evaluates problem behaviors as reported by the parent or alternative caregivers. The CPRS-R:S total score comprises 27 items and covers a subset of the subscales and items on the long parent form.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Global Impression (CGI) scores</measure>
    <time_frame>Improvement from Baseline to combined week 6 (visit 6) and week 7 (visit 7)</time_frame>
    <description>The CGI scale permits a global evaluation of the subject's improvement over time. Prior to dosing (at baseline), the investigator assessed the severity of the subject's condition using a CGI-Severity (CGI-S) Scale. During the Dose Optimization Period and the Double-Blind Treatment Period, the investigator assessed the subject's improvement relative to symptoms prior to dosing, using the CGI-I Scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>d-Amphetamine Transdermal System</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>d-Amphetamine Transdermal System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo patch</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo patch</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>d-Amphetamine Transdermal System</intervention_name>
    <description>Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied.</description>
    <arm_group_label>d-Amphetamine Transdermal System</arm_group_label>
    <other_name>d-Amphetamine</other_name>
    <other_name>Amphetamine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo patch</intervention_name>
    <description>Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied.</description>
    <arm_group_label>Placebo patch</arm_group_label>
    <other_name>Placebo</other_name>
    <other_name>Sham treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Gender: Male or female&#xD;
&#xD;
          2. Age: Between 6 and 17 years of age (inclusive)&#xD;
&#xD;
          3. Race: All eligible&#xD;
&#xD;
          4. Females of child-bearing potential must have agreed to practice a clinically accepted&#xD;
             method of contraception during the study and for at least 1 month prior to study&#xD;
             dosing and 1 month following completion of the study. Acceptable contraceptive methods&#xD;
             included abstinence, oral contraception, surgical sterilization (bilateral tubal&#xD;
             ligation, bilateral oophorectomy, or hysterectomy), intrauterine device, diaphragm in&#xD;
             addition to spermicidal foam and condom on male partner, or systemic contraception&#xD;
             (e.g., Norplant System)&#xD;
&#xD;
          5. Must have met Diagnostic and Statistical Manual of Mental Disorders, 4th edition -&#xD;
             Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD combined,&#xD;
             hyperactive/impulsive subtype, or predominately inattentive subtype&#xD;
&#xD;
          6. The Screening and Baseline visit ADHD-RS-IV total score must have been ≥90% of the&#xD;
             general population of children by age and gender&#xD;
&#xD;
          7. Able to wear a patch for 9 hours (for children and, if applicable, for adolescents,&#xD;
             parent or caregiver must be present to apply and remove the patches and maintain the&#xD;
             used and unused patches in a secure, controlled area of the home)&#xD;
&#xD;
          8. Functioning at an age-appropriate level intellectually as determined by an&#xD;
             intelligence quotient (IQ) of ≥80 on the Wechsler Abbreviated Scale of Intelligence&#xD;
             II™ (WASI II™) vocabulary and matrix reasoning components&#xD;
&#xD;
          9. Must have been able to complete PERMP assessment&#xD;
&#xD;
         10. Must have provided parental consent (signed ICF) and obtained written/verbal assent&#xD;
             from the subject&#xD;
&#xD;
         11. Subject and parent(s)/ caregiver must have been willing and able to comply with all&#xD;
             the protocol requirements and parent(s) or caregiver must be able to provide&#xD;
             transportation for the subject to and from the analog classroom sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Blood pressure outside the 95th percentile for age and gender&#xD;
&#xD;
          2. Pulse of &lt;50 (age 6 - 17), or &gt;120 (age 6 - 12), or &gt;125 (age 13 - 17)&#xD;
&#xD;
          3. Known non-responder to amphetamine treatment&#xD;
&#xD;
          4. Documented allergy, intolerance, or hypersensitivity to amphetamine&#xD;
&#xD;
          5. Currently taking an ADHD medication that is providing symptom control with no residual&#xD;
             impairment at home or school and has acceptable tolerability and adherence&#xD;
&#xD;
          6. Recent history (within the past 6 months) of suspected substance abuse or dependence&#xD;
             disorder (including nicotine)&#xD;
&#xD;
          7. History of seizures during the last 2 years (excluding infantile febrile seizures), a&#xD;
             tic disorder (exclusive of transient tic disorder), a current diagnosis, and/or a&#xD;
             family history of Tourette's Disorder. Mild medication-induced tics were not&#xD;
             exclusionary&#xD;
&#xD;
          8. Any psychiatric disorder that could interfere with study participation or the safety&#xD;
             of the subject or other participants, such as conduct disorder (CD) or oppositional&#xD;
             defiant disorder (ODD) with a history of prominent aggressive outbursts. Children&#xD;
             meeting CD or ODD but without prominent aggression will be allowed to enroll at the&#xD;
             discretion of the Investigator&#xD;
&#xD;
          9. Autism or Asperger's Disorder&#xD;
&#xD;
         10. Family history (first degree relatives) of sudden cardiac death&#xD;
&#xD;
         11. Current controlled (requiring medication) or uncontrolled comorbid psychiatric&#xD;
             conditions such as post-traumatic stress disorder, psychosis, bipolar illness, severe&#xD;
             obsessive compulsive disorder, severe depressive or severe anxiety disorder, was&#xD;
             considered a suicide risk, had recent (last 6 months) suicidal ideation, or any&#xD;
             lifetime self-harm event&#xD;
&#xD;
         12. History of abnormal thyroid function&#xD;
&#xD;
         13. Has a body mass index (BMI) for age greater than 95th percentile per Centers for&#xD;
             Disease Control BMI (for gender-specific charts)&#xD;
&#xD;
         14. Known history of symptomatic cardiovascular disease, advanced arteriosclerosis,&#xD;
             structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities,&#xD;
             coronary artery disease, or other serious cardiac problems that may place them at&#xD;
             increased vulnerability to the sympathomimetic effects of a stimulant drug&#xD;
&#xD;
         15. Any skin abnormality present at the potential application site (i.e., infection, rash,&#xD;
             atrophy, excessive fragility or dryness, any cut or abrasion, or tattoo)&#xD;
&#xD;
         16. History of hypersensitivity, allergy to topical medication, preparation, or adhesive&#xD;
             dressings&#xD;
&#xD;
         17. Concurrent chronic or significant acute illnesses (such as severe allergic rhinitis or&#xD;
             an infectious process requiring antibiotics, unless expected to resolve or has&#xD;
             resolved by Day 0) disability or any unstable medical condition that in the&#xD;
             Investigator's opinion would lead to difficulty complying with the protocol&#xD;
             requirements&#xD;
&#xD;
         18. Used any investigational drug within 30 days of the Screening visit&#xD;
&#xD;
         19. History of physical, sexual, or emotional abuse in the last year&#xD;
&#xD;
         20. Medical history of hepatitis A/B/C or HIV&#xD;
&#xD;
         21. Positive urine drug screen for drugs of abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Waxmonsky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Not Affiliated</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California - Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida International University Center for Children and Families</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33199</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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <disposition_first_submitted>April 1, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>April 1, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">April 30, 2014</disposition_first_posted>
  <last_update_submitted>April 11, 2022</last_update_submitted>
  <last_update_submitted_qc>April 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amphetamine</mesh_term>
    <mesh_term>Dextroamphetamine</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>April 22, 2022</submitted>
    <returned>May 19, 2022</returned>
    <submitted>June 27, 2023</submitted>
    <returned>July 19, 2023</returned>
    <submitted>August 11, 2023</submitted>
    <submission_canceled>August 11, 2023</submission_canceled>
    <submitted>August 31, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01711021
org study id: N25-006
nct id: NCT01711021
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
This study will evaluate safety and efficacy of d-Amphetamine Transdermal System for the
      treatment of Attention Deficit Hyperactivity Disorder in children and adolescents.
The study will consist of a four-week screening period, a 3-day wash-out period (if
      applicable), a five-week open-label, step-wise dose optimization period and two-week double
      blind randomized crossover treatment period with weekly classroom assessments and a safety
      follow-up by telephone 7 - 10 days after last dose of study drug.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) total score
time frame: Pre-dose through all post-dose time points up to 12 hours post-dose (3 hours post-removal)
description: The SKAMP total score comprises all 13 items. The SKAMP was designed for independent observers to rate 13 items representing 2 factors of classroom behavior: attention (SKAMP-A) and deportment (SKAMP-D), as well as quality of work. Items are specific to place (classroom setting) and time (during a typical classroom period), and the scale is used to assess multiple ratings taken within a day.
The SKAMP-D subscale evaluates deportment, including interacting with other children, interacting with adults, remaining quiet according to classroom rules, and staying seated according to classroom rules. The SKAMP-A subscale is a measure of attention and evaluates getting started on assignments, sticking with tasks, attending to an activity, and making activity transitions. The SKAMP quality of work subscale includes 3 items: completing assigned work, performing work accurately, and being careful and neat while writing or drawing.
measure: Change in the onset of clinical effect for the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) total score
time frame: Onset of efficacy defined as the time of the first assessment time showing statistical significance between d-ATS and placebo: 2 hours post-dose
description: The SKAMP total score comprises all 13 items. The SKAMP was designed for independent observers to rate 13 items representing 2 factors of classroom behavior: attention (SKAMP-A) and deportment (SKAMP-D), as well as quality of work. Items are specific to place (classroom setting) and time (during a typical classroom period), and the scale is used to assess multiple ratings taken within a day.
The SKAMP-D subscale evaluates deportment, including interacting with other children, interacting with adults, remaining quiet according to classroom rules, and staying seated according to classroom rules. The SKAMP-A subscale is a measure of attention and evaluates getting started on assignments, sticking with tasks, attending to an activity, and making activity transitions. The SKAMP quality of work subscale includes 3 items: completing assigned work, performing work accurately, and being careful and neat while writing or drawing.
measure: Change in the duration of clinical effect for the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) total score
time frame: Double-blind Week 6 and Week 7: Duration of Effect from onset (2 hours) and up to 12 hours post-dose (p<0.001)
description: The SKAMP total score comprises all 13 items. The SKAMP was designed for independent observers to rate 13 items representing 2 factors of classroom behavior: attention (SKAMP-A) and deportment (SKAMP-D), as well as quality of work. Items are specific to place (classroom setting) and time (during a typical classroom period), and the scale is used to assess multiple ratings taken within a day.
The SKAMP-D subscale evaluates deportment, including interacting with other children, interacting with adults, remaining quiet according to classroom rules, and staying seated according to classroom rules. The SKAMP-A subscale is a measure of attention and evaluates getting started on assignments, sticking with tasks, attending to an activity, and making activity transitions. The SKAMP quality of work subscale includes 3 items: completing assigned work, performing work accurately, and being careful and neat while writing or drawing.
measure: Change in Permanent Product Measure of Performance (PERMP) scores
time frame: 1,2, 3, 4.5,6,7,9,10 and 12 hours post-dose on combined double blind period (week 6 and week 7)
description: To assess efficacy of d-ATS compared to placebo as measured by the PERMP-C (number of correct answers) and PERMP-A (number of attempted answers) score. The PERMP is an age-adjusted written math test, of 10 minutes' duration administered at multiple time points. Subjects are given 5 pages of 80 math problems (400 total problems) and are instructed to work at their desks and to complete as many problems as possible in 10 minutes. Performance is measured as the number of problems attempted (PERMP-A) and the number of problems worked correctly (PERMP-C).
measure: Change in the clinician-rated scale of ADHD symptoms based on DSM-IV-TR criteria (ADHD-RS-IV).
time frame: Combined Week 6 (visit 6) and Week 7 (visit 7) in the Double-Blind Cross-Over period
description: The ADHD-RS-IV is based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria to assess efficacy of d-ATS compared to placebo. The ADHD-RS-IV scale was developed to measure the behaviors of children with ADHD, and it consists of 18 items designed to reflect current symptomatology of ADHD based on DSM-IV criteria. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0 to 54.
measure: Change in Conners Parent Rating Scale Revised Short Form (CPRS-R:S) total scores
time frame: Baseline to combined week 6 and 7
description: The CPRS-R:S evaluates problem behaviors as reported by the parent or alternative caregivers. The CPRS-R:S total score comprises 27 items and covers a subset of the subscales and items on the long parent form.
measure: Change in Clinical Global Impression (CGI) scores
time frame: Improvement from Baseline to combined week 6 (visit 6) and week 7 (visit 7)
description: The CGI scale permits a global evaluation of the subject's improvement over time. Prior to dosing (at baseline), the investigator assessed the severity of the subject's condition using a CGI-Severity (CGI-S) Scale. During the Dose Optimization Period and the Double-Blind Treatment Period, the investigator assessed the subject's improvement relative to symptoms prior to dosing, using the CGI-I Scale.
arm group label: d-Amphetamine Transdermal System
arm group type: Active Comparator
description: d-Amphetamine Transdermal System
arm group label: Placebo patch
arm group type: Placebo Comparator
description: Placebo patch
intervention type: Drug
intervention name: d-Amphetamine Transdermal System
description: Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied.
arm group label: d-Amphetamine Transdermal System
other name: d-Amphetamine
other name: Amphetamine
intervention type: Drug
intervention name: Placebo patch
description: Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied.
arm group label: Placebo patch
other name: Placebo
other name: Sham treatment
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: James Waxmonsky, MD
role: Principal Investigator
affiliation: Not Affiliated
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Attention Deficit Disorder with Hyperactivity
mesh term: Amphetamine
mesh term: Dextroamphetamine
submitted: April 22, 2022
returned: May 19, 2022
submitted: June 27, 2023
returned: July 19, 2023
submitted: August 11, 2023
submission canceled: August 11, 2023
submitted: August 31, 2023