<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/NCT02993861</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00070924</org_study_id>
    <nct_id>NCT02993861</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Anti-epileptic Drugs in Obese Children</brief_title>
  <official_title>Pharmacokinetics of Anti-epileptic Drugs in Obese Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christoph P Hornik, MD MPH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Emmes Company, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to&#xD;
      characterize the pharmacokinetics and safety of four oral anti-epileptics drugs&#xD;
      (levetiracetam, valproic acid [divalproex sodium ER or immediate release formulation if&#xD;
      inadequate enrollment}, topiramate, and oxcarbazepine) in a non-randomized sample of obese&#xD;
      children and adolescents. The study's duration will be up to eleven days (up to seven days of&#xD;
      screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18&#xD;
      years will be identified through outpatient clinic schedules and inpatient admissions at each&#xD;
      clinic site. Participants receiving at least one of the study drugs per local standard of&#xD;
      care will have pharmacokinetic concentrations in plasma drawn according to the specific&#xD;
      dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip&#xD;
      ratio, medical history, concomitant medication history, documentation of study drug oral&#xD;
      intake, adverse effects, and physical examination. The sample size will include 24&#xD;
      participants for each anti-epileptic drug (total 96).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 9, 2016</start_date>
  <completion_date type="Actual">October 17, 2019</completion_date>
  <primary_completion_date type="Actual">October 10, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Steady-state pharmacokinetics area under the curve</measure>
    <time_frame>Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Steady-state pharmacokinetics maximum concentration</measure>
    <time_frame>Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Steady-state pharmacokinetics time to reach maximum concentration</measure>
    <time_frame>Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Steady-state pharmacokinetics oral apparent volume of distribution</measure>
    <time_frame>Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Steady-state pharmacokinetics half life</measure>
    <time_frame>Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Steady-state pharmacokinetics oral apparent clearance</measure>
    <time_frame>Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Steady-state pharmacokinetics absorption rate constant</measure>
    <time_frame>Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events</measure>
    <time_frame>Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)</time_frame>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">106</enrollment>
  <condition>Epilepsy</condition>
  <condition>Obese</condition>
  <arm_group>
    <arm_group_label>Levetiracetam</arm_group_label>
    <description>Children with epilepsy who are treated with levetiracetam per local standard of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Valproic Acid</arm_group_label>
    <description>Children with epilepsy who are treated with valproic acid per local standard of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topiramate</arm_group_label>
    <description>Children with epilepsy who are treated with topiramate per local standard of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxcarbazepine</arm_group_label>
    <description>Children with epilepsy who are treated with oxcarbazepine per local standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anti-epileptics</intervention_name>
    <arm_group_label>Levetiracetam</arm_group_label>
    <arm_group_label>Oxcarbazepine</arm_group_label>
    <arm_group_label>Topiramate</arm_group_label>
    <arm_group_label>Valproic Acid</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with epilepsy who are inpatients in local hospital or managed in outpatient&#xD;
        settings - community sample.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  2 years to &lt; 18 years at the time of enrollment&#xD;
&#xD;
          -  BMI ≥ 95th percentile for age and sex, based on CDC recommendations&#xD;
&#xD;
          -  Informed consent/HIPAA from the parent/legal guardian and assent (as applicable)&#xD;
&#xD;
          -  Receiving ≥ 1 of the study drugs per local standard of care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known pregnancy as determined via interview or test results, if available&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kanecia Zimmerman, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Medical Center/Duke Clinical Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemours Alfred I. DuPont Hospital for Children</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens Healthcare of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann and Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville Norton Childrens Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Health System</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Children's Services</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-8589</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>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Duke University</investigator_affiliation>
    <investigator_full_name>Christoph P Hornik, MD MPH</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Epilepsy</keyword>
  <keyword>Obese</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anticonvulsants</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02993861
org study id: Pro00070924
nct id: NCT02993861
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to
      characterize the pharmacokinetics and safety of four oral anti-epileptics drugs
      (levetiracetam, valproic acid [divalproex sodium ER or immediate release formulation if
      inadequate enrollment}, topiramate, and oxcarbazepine) in a non-randomized sample of obese
      children and adolescents. The study's duration will be up to eleven days (up to seven days of
      screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18
      years will be identified through outpatient clinic schedules and inpatient admissions at each
      clinic site. Participants receiving at least one of the study drugs per local standard of
      care will have pharmacokinetic concentrations in plasma drawn according to the specific
      dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip
      ratio, medical history, concomitant medication history, documentation of study drug oral
      intake, adverse effects, and physical examination. The sample size will include 24
      participants for each anti-epileptic drug (total 96).
observational model: Cohort
time perspective: Prospective
measure: Steady-state pharmacokinetics area under the curve
time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
measure: Steady-state pharmacokinetics maximum concentration
time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
measure: Steady-state pharmacokinetics time to reach maximum concentration
time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
measure: Steady-state pharmacokinetics oral apparent volume of distribution
time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
measure: Steady-state pharmacokinetics half life
time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
measure: Steady-state pharmacokinetics oral apparent clearance
time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
measure: Steady-state pharmacokinetics absorption rate constant
time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
measure: Serious adverse events
time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
arm group label: Levetiracetam
description: Children with epilepsy who are treated with levetiracetam per local standard of care
arm group label: Valproic Acid
description: Children with epilepsy who are treated with valproic acid per local standard of care
arm group label: Topiramate
description: Children with epilepsy who are treated with topiramate per local standard of care
arm group label: Oxcarbazepine
description: Children with epilepsy who are treated with oxcarbazepine per local standard of care
intervention type: Other
intervention name: Anti-epileptics
arm group label: Levetiracetam
arm group label: Oxcarbazepine
arm group label: Topiramate
arm group label: Valproic Acid
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: No
last name: Kanecia Zimmerman, MD, MPH
role: Principal Investigator
affiliation: Duke Medical Center/Duke Clinical Research Institute
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Duke University
investigator full name: Christoph P Hornik, MD MPH
investigator title: Associate Professor of Pediatrics
mesh term: Epilepsy
mesh term: Anticonvulsants