<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/NCT02253745</url>
  </required_header>
  <id_info>
    <org_study_id>V81444-1CNS-01</org_study_id>
    <nct_id>NCT02253745</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, PK &amp; Efficacy of V81444 in Volunteers With Attention Deficit/ Hyperactivity Disorder (ADHD)</brief_title>
  <official_title>A Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Repeat Oral Doses of V81444 in Volunteers With Attention Deficit / Hyperactivity Disorder (ADHD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vernalis (R&amp;D) Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vernalis (R&amp;D) Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to evaluate the safety, tolerability, effectiveness,&#xD;
      and pharmacokinetics (PK) of twice daily oral doses of V81444 in adults with ADHD.&#xD;
      Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and&#xD;
      eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood&#xD;
      samples will be taken throughout the study for PK analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 1/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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ADHD-RS</measure>
    <time_frame>5 weeks</time_frame>
    <description>The absolute and change from baseline in ADHD-RS scores, and percentage change from baseline in ADHD-RS score will be summarized appropriately</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PERM-P</measure>
    <time_frame>5 weeks</time_frame>
    <description>The average of the on-treatment total post-dose PERM-P scores for each treatment assessment day during the randomized treatment period will be calculated for each individual.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression (CGI)</measure>
    <time_frame>5 weeks</time_frame>
    <description>The CGI scores will be summarised using frequency counts and percentages.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability</measure>
    <time_frame>11 weeks</time_frame>
    <description>Parameters for evaluation of safety and tolerability:&#xD;
Adverse events, Clinical laboratory safety tests, Physical examination, Vital signs, 12-lead ECG, Telemetry, EGD findings, CSSRS, LSEQ</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>ADHD</condition>
  <arm_group>
    <arm_group_label>Placebo:V81444</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo followed by a 7 day washout then V81444</description>
  </arm_group>
  <arm_group>
    <arm_group_label>V81444:placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>V81444 followed by a 7 day washout then Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>V81444</intervention_name>
    <description>V81444 capsules for oral administration, 100 mg twice daily for 13 days and once on Day 14</description>
    <arm_group_label>Placebo:V81444</arm_group_label>
    <arm_group_label>V81444:placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Capsules to match V81444 twice daily for 13 days and once on Day 14</description>
    <arm_group_label>Placebo:V81444</arm_group_label>
    <arm_group_label>V81444:placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must:&#xD;
&#xD;
               1. Be male or female subjects aged 18 to 50 years inclusive&#xD;
&#xD;
               2. Meet DSM-IV-TR criteria for a primary diagnosis of ADHD combined,&#xD;
                  hyperactive-impulsive or predominantly inattentive type; confirmed by a minimum&#xD;
                  score of 24 on the ADHD-RS with adult prompts:&#xD;
&#xD;
               3. Have a body mass index (BMI) between 19 and 32 kg/m2 inclusive&#xD;
&#xD;
               4. Be willing and able to comply with the requirements of the entire study&#xD;
&#xD;
               5. Be able to read and understand English&#xD;
&#xD;
               6. Give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have a significant medical condition or a history of such a condition that the&#xD;
             Investigator considers should exclude the subject from the study&#xD;
&#xD;
          2. Have any other significant psychiatric disorder, as determined by the Structured&#xD;
             Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I)&#xD;
&#xD;
          3. Have known mental impairment defined as an intelligence quotient (IQ) less than 75, or&#xD;
             clinical evidence of mental impairment based on the opinion of the Investigator&#xD;
&#xD;
          4. Have a history or evidence of clinically significant GI disease, including ulcers,&#xD;
             gastro-esophageal reflux disease, hiatus hernia or gastritis&#xD;
&#xD;
          5. Have had any previous gastric surgery and/or bariatric procedure&#xD;
&#xD;
          6. Have any known malformations that would make EGD difficult or unsafe&#xD;
&#xD;
          7. Have taken any prohibited concomitant medication&#xD;
&#xD;
          8. Have multiple drug allergies or be allergic to any of the components of V81444 study&#xD;
             medication or its matching placebo (see Section 7.1) or lidocaine&#xD;
&#xD;
          9. Have abused drugs in the 12 months before study drug administration&#xD;
&#xD;
         10. In the 90 days before study drug administration, on average&#xD;
&#xD;
               -  have smoked more than 5 cigarettes per day&#xD;
&#xD;
               -  have consumed more than 28 units of alcohol per week&#xD;
&#xD;
               -  have consumed more than 500 mg of caffeine per day&#xD;
&#xD;
         11. In the 2 calendar months before study drug administration&#xD;
&#xD;
               -  have donated blood or plasma in excess of 500 mL&#xD;
&#xD;
               -  been exposed to any new investigational agent&#xD;
&#xD;
         12. In the calendar month prior to screening&#xD;
&#xD;
               -  used non-steroidal anti-inflammatory drugs regularly&#xD;
&#xD;
               -  had a new tattoo or body piercing&#xD;
&#xD;
         13. Have any clinically relevant abnormal findings at Screening and/or admission&#xD;
&#xD;
         14. Plan to undergo elective procedures/surgery at any time during the study&#xD;
&#xD;
         15. Have any other condition that might increase the risk to the individual or decrease&#xD;
             the chance of obtaining satisfactory data, as assessed by the Investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bradley Vince, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VACR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vince and Associates Clinical Research</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <disposition_first_submitted>June 1, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>December 9, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">January 11, 2016</disposition_first_posted>
  <last_update_submitted>May 4, 2016</last_update_submitted>
  <last_update_submitted_qc>May 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD</keyword>
  <keyword>Attention Deficit/ Hyperactivity Disorder</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>
  <!-- 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/NCT02253745
org study id: V81444-1CNS-01
nct id: NCT02253745
lead sponsor: 
has dmc: No
The purpose of this research study is to evaluate the safety, tolerability, effectiveness,
      and pharmacokinetics (PK) of twice daily oral doses of V81444 in adults with ADHD.
      Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and
      eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood
      samples will be taken throughout the study for PK analysis.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: ADHD-RS
time frame: 5 weeks
description: The absolute and change from baseline in ADHD-RS scores, and percentage change from baseline in ADHD-RS score will be summarized appropriately
measure: PERM-P
time frame: 5 weeks
description: The average of the on-treatment total post-dose PERM-P scores for each treatment assessment day during the randomized treatment period will be calculated for each individual.
measure: Clinical Global Impression (CGI)
time frame: 5 weeks
description: The CGI scores will be summarised using frequency counts and percentages.
measure: Safety and Tolerability
time frame: 11 weeks
description: Parameters for evaluation of safety and tolerability:
Adverse events, Clinical laboratory safety tests, Physical examination, Vital signs, 12-lead ECG, Telemetry, EGD findings, CSSRS, LSEQ
arm group label: Placebo:V81444
arm group type: Experimental
description: Placebo followed by a 7 day washout then V81444
arm group label: V81444:placebo
arm group type: Experimental
description: V81444 followed by a 7 day washout then Placebo
intervention type: Drug
intervention name: V81444
description: V81444 capsules for oral administration, 100 mg twice daily for 13 days and once on Day 14
arm group label: Placebo:V81444
arm group label: V81444:placebo
intervention type: Drug
intervention name: Placebo
description: Capsules to match V81444 twice daily for 13 days and once on Day 14
arm group label: Placebo:V81444
arm group label: V81444:placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Bradley Vince, MD
role: Principal Investigator
affiliation: VACR
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity