<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/NCT03014440</url>
  </required_header>
  <id_info>
    <org_study_id>13-010562</org_study_id>
    <nct_id>NCT03014440</nct_id>
  </id_info>
  <brief_title>Study of Cannabidiol for Drug-Resistant Epilepsies</brief_title>
  <official_title>A Phase 1/2, Safety, Tolerability, and Dose-Finding Study of Cannabidiol for Drug-Resistant Epilepsies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eric Marsh, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Geisinger Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital of Philadelphia</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if cannabidiol is safe and effective at different&#xD;
      doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has&#xD;
      potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure&#xD;
      frequency. There are only a few open label studies that have demonstrated the safety and&#xD;
      tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies&#xD;
      were performed either retrospectively or with varying cannabidiol preparations. There are no&#xD;
      well-documented studies and completely analyzed data for pediatric epileptic patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <condition>Drug Resistant Epilepsy</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cannabidiol</intervention_name>
    <other_name>CBD</other_name>
    <other_name>Epidiolex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ages between 1 year old and 20 years old, male or female at the first visit, Week -4&#xD;
             (at time informed consent form is signed)&#xD;
&#xD;
          2. Documentation of a diagnosis of drug-resistant epilepsy as proven by and documented&#xD;
             with medical records and/or the following clinical features (must have all 3 of the&#xD;
             following):&#xD;
&#xD;
               1. Failure to control seizures despite appropriate trial of 3 or more AEDs at&#xD;
                  therapeutic doses&#xD;
&#xD;
               2. An intractable childhood epilepsy including, Dravet Syndrome or Lennox-Gastaut&#xD;
                  Syndrome&#xD;
&#xD;
               3. Must report at least 3 countable (non-countable seizures includes absence and&#xD;
                  myoclonic) seizures per month&#xD;
&#xD;
          3. Between 1-3 baseline AEDs . Vagus nerve stimulator (VNS), ketogenic diet, and modified&#xD;
             Atkins diet do not count towards this limit.&#xD;
&#xD;
          4. VNS must be on stable settings for a minimum of 3 months.&#xD;
&#xD;
          5. If on the ketogenic diet, must be on stable ratio for a minimum of 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Epilepsies associated with neurodegenerative diseases, including neuronal&#xD;
             ceroidolipofuscinosis, progressive myoclonus epilepsies, Rasmussen encephalitis, and&#xD;
             tumors&#xD;
&#xD;
          2. Epilepsies associated with an inborn error of metabolism, including mitochondrial&#xD;
             disorders&#xD;
&#xD;
          3. Felbatol initiated within the past 12 months&#xD;
&#xD;
          4. Use of any Cannabis-related product (including hemp oil) in the past 12 months as&#xD;
             assessed by parental questioning.&#xD;
&#xD;
          5. Laboratory values on comprehensive metabolic panel (CMP) and complete blood count&#xD;
             (CBC) testing that are Class 3 or higher according to the CTCAE v4.0.&#xD;
&#xD;
          6. Positive pregnancy test.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>20 Years</maximum_age>
  </eligibility>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>March 30, 2017</last_update_submitted>
  <last_update_submitted_qc>March 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital of Philadelphia</investigator_affiliation>
    <investigator_full_name>Eric Marsh, MD</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics and Neurology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Drug Resistant Epilepsy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cannabidiol</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/NCT03014440
org study id: 13-010562
nct id: NCT03014440
lead sponsor: 
collaborator: 
collaborator: 
The purpose of this study is to determine if cannabidiol is safe and effective at different
      doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has
      potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure
      frequency. There are only a few open label studies that have demonstrated the safety and
      tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies
      were performed either retrospectively or with varying cannabidiol preparations. There are no
      well-documented studies and completely analyzed data for pediatric epileptic patients.
intervention type: Drug
intervention name: Cannabidiol
other name: CBD
other name: Epidiolex
criteria: 
gender: All
minimum age: 1 Year
maximum age: 20 Years
responsible party type: Sponsor-Investigator
investigator affiliation: Children's Hospital of Philadelphia
investigator full name: Eric Marsh, MD
investigator title: Assistant Professor of Pediatrics and Neurology
mesh term: Epilepsy
mesh term: Drug Resistant Epilepsy
mesh term: Cannabidiol