<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/NCT04485104</url>
  </required_header>
  <id_info>
    <org_study_id>GWEP17005</org_study_id>
    <secondary_id>2020-002132-67</secondary_id>
    <nct_id>NCT04485104</nct_id>
  </id_info>
  <brief_title>Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures</brief_title>
  <official_title>An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to &lt; 2 Years of Age), Dravet Syndrome (1 Year to &lt; 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to &lt; 2 Years of Age) Who Experience Inadequately-controlled Seizures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jazz Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jazz Pharmaceuticals</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>
      This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of&#xD;
      adjunctive GWP42003-P in participants &lt; 2 years of age with tuberous sclerosis complex (TSC),&#xD;
      Lennox-Gastaut syndrome (LGS), or Dravet syndrome (DS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study duration will be up to approximately 62 weeks, including a 4-week&#xD;
      screening/baseline period, a 52-week dose optimization treatment period (which includes a&#xD;
      fixed 2-week titration period followed by flexible dose optimization), a 10-day taper period,&#xD;
      and a safety follow-up period (4 weeks after the end-of-taper visit).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 19, 2021</start_date>
  <completion_date type="Anticipated">December 27, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 29, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Blood Pressure</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Pulse Rate</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Respiration Rate</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change from Baseline in Body Temperature</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Height</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Body Weight</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Heart Rate</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in RR Interval</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in PR Interval</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in QRS Duration</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in QT Interval</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in QTcB and QTcF</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with a Clinically Significant Change in Laboratory Parameters</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Emergence of New Types of Seizures</measure>
    <time_frame>From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentrations of GWP42003-P and its Major Metabolites</measure>
    <time_frame>Predose, 3 hours and 6 hours post dose on Days 1, 15, 29, 57, and End of Treatment (Week 52)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage Change from Baseline in Indication-Specific Total Countable Seizures as Recorded by Caregivers and Investigators</measure>
    <time_frame>Week 12, and every 4 weeks thereafter, up to Week 52</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Responders</measure>
    <time_frame>Week 12, and every 4 weeks thereafter, up to Week 52</time_frame>
    <description>Treatment Responders are defined as participants with ≥ 50% reduction from baseline in caregiver- and Investigator-Reported total countable seizures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change from Baseline in Total Countable Seizures</measure>
    <time_frame>Week 12, and every 4 weeks thereafter, up to Week 52</time_frame>
    <description>This endpoint includes the following changes in percentage of seizures:&#xD;
&gt; 25% (increase);&#xD;
≥ 0% to ≤ 25% (increase);&#xD;
&gt; -25% to &lt; 0% (reduction);&#xD;
&gt; -50% to ≤ -25% (reduction);&#xD;
&gt; -75% to ≤ -50% (reduction);&#xD;
≤ -75% (reduction).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieved Seizure-Free Status</measure>
    <time_frame>Week 12, and every 4 weeks thereafter, up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Still Receiving GWP42003-P</measure>
    <time_frame>Week 12, and every 4 weeks thereafter, up to Week 52</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">27</enrollment>
  <condition>Seizure in Participants With Tuberous Sclerosis Complex</condition>
  <condition>Seizure in Participants With Dravet Syndrome</condition>
  <condition>Seizure in Participants With Lennox-Gastaut Syndrome</condition>
  <arm_group>
    <arm_group_label>GWP42003-P</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 52-week treatment period includes a fixed 2-week titration schedule followed by flexible dose optimization.&#xD;
Day 1: 5 mg/kg/day (2.5 mg/kg twice daily (b.i.d.))&#xD;
Day 8: 10 mg/kg/day (5 mg/kg b.i.d.)&#xD;
Day 15 to Week 52: Flexible dosing based on the participant's observed efficacy, safety, and tolerability per the investigator's clinical judgement. Up to a maximum of 20 mg/kg/day (10 mg/kg b.i.d.) for LGS and DS or 25 mg/kg/day (12.5 mg/kg b.i.d.) for TSC, in maximum weekly increments of 5 mg/kg/day (≤ 2.5 mg/kg b.i.d.).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GWP42003-P</intervention_name>
    <description>Oral Solution</description>
    <arm_group_label>GWP42003-P</arm_group_label>
    <other_name>Cannabidiol</other_name>
    <other_name>Epidiolex</other_name>
    <other_name>Epidyolex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Participants with TSC (1 month to &lt; 2 years of age), or DS (1 year to &lt; 2 years of&#xD;
             age), or LGS (1 year to &lt; 2 years of age) within the specified age range at the time&#xD;
             of initial informed consent.&#xD;
&#xD;
          -  Parent(s)/legal representative is/are willing and able to give informed consent for&#xD;
             participation in the study.&#xD;
&#xD;
          -  Parent(s)/legal representative is/are willing and able (in the investigator's opinion)&#xD;
             to comply with all study requirements (including accurate electronic&#xD;
             participant-reported outcome [ePRO] diary completion).&#xD;
&#xD;
          -  Participants with TSC must have a diagnosis per the 2012 International Tuberous&#xD;
             Sclerosis Complex Consensus Conference. Participants with LGS or DS must have a&#xD;
             diagnosis that is consistent with International League Against Epilepsy (ILAE)&#xD;
             guidelines and confirmed by the Epilepsy Study Consortium (ESCI).&#xD;
&#xD;
          -  Participants who have uncontrolled seizures, and who are currently receiving 1 or more&#xD;
             antiseizure medication (ASMs).&#xD;
&#xD;
          -  A suitable VEEG, as available in the medical record, within 1 year of Visit 1. When a&#xD;
             historical VEEG is not available, and if clinically indicated and appropriate (due to&#xD;
             uncertainties or new seizures), a VEEG will be completed and read to confirm diagnosis&#xD;
             prior to Visit 3. All VEEGs are to be read at baseline by the investigator and by an&#xD;
             independent reviewer.&#xD;
&#xD;
          -  Has seizures which are not adequately controlled through their current ASMs, defined&#xD;
             as ≥ 1 seizure reported on the seizure diary during the screening/baseline period&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Has tumor growth which, in the opinion of the investigator, could affect participant&#xD;
             safety.&#xD;
&#xD;
          -  Has clinically significant abnormal laboratory values, in the investigator's opinion,&#xD;
             at screening/baseline.&#xD;
&#xD;
          -  Has clinically significant abnormalities in the electrocardiogram (ECG) measured at&#xD;
             screening/baseline.&#xD;
&#xD;
          -  Has any concurrent cardiovascular conditions, that will, in the investigator's&#xD;
             opinion, interfere with the ability to assess their ECGs.&#xD;
&#xD;
          -  Has any known or suspected hypersensitivity to cannabinoids or any of the excipients&#xD;
             of the study intervention such as sesame seed oil.&#xD;
&#xD;
          -  Has significantly impaired hepatic function prior to Visit 3, defined as:&#xD;
&#xD;
               -  Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt; 3 ×&#xD;
                  upper limit of normal (ULN) and (total bilirubin [TBL] &gt; 2 × ULN or international&#xD;
                  normalized ratio [INR] &gt; 1.5).&#xD;
&#xD;
               -  Serum ALT or AST &gt; 5 × ULN.&#xD;
&#xD;
               -  Serum ALT or AST &gt; 3 × ULN with the presence of fatigue, nausea, vomiting, right&#xD;
                  upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (&gt; 5%).&#xD;
&#xD;
               -  Elevated ALT or AST should be discussed with the medical monitor prior to Visit&#xD;
                  3; the medical monitor may allow for a confirmatory re-draw prior to Visit 3.&#xD;
&#xD;
          -  Has any other clinically significant disease or disorder which, in the opinion of the&#xD;
             investigator, may either put the participant, other participants, or site staff at&#xD;
             risk because of participation in the study, may influence the result of the study, or&#xD;
             may affect the participant's ability to take part in the study.&#xD;
&#xD;
          -  Any clinically significant abnormalities identified following a physical examination&#xD;
             of the participant that, in the opinion of the investigator, would jeopardize the&#xD;
             safety of the participant if they took part in the study.&#xD;
&#xD;
          -  Has previously been enrolled into this study.&#xD;
&#xD;
          -  Has plans to travel outside their country of residence during the study, unless the&#xD;
             participant has confirmation that the study intervention is permitted in the&#xD;
             destination country.&#xD;
&#xD;
        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>23 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Clinical Trial Disclosure &amp; Transparency</last_name>
    <phone>215-832-3750</phone>
    <email>ClinicalTrialDisclosure@JazzPharma.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>August 18, 2023</last_update_submitted>
  <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Epilepsy</keyword>
  <keyword>Seizures</keyword>
  <keyword>Infantile Spasms</keyword>
  <keyword>Tumors</keyword>
  <keyword>Pediatric</keyword>
  <keyword>Children</keyword>
  <keyword>Infants</keyword>
  <keyword>Cannabidiol oral solution</keyword>
  <keyword>GWP42003-P</keyword>
  <keyword>Tuberous Sclerosis Complex</keyword>
  <keyword>TSC</keyword>
  <keyword>Tuberous Sclerosis</keyword>
  <keyword>Cannabidiol</keyword>
  <keyword>Epidiolex</keyword>
  <keyword>CBD</keyword>
  <keyword>Seizure</keyword>
  <keyword>Child</keyword>
  <keyword>TSC1</keyword>
  <keyword>TSC2</keyword>
  <keyword>Tuberous Sclerosis 1</keyword>
  <keyword>Tuberous Sclerosis 2</keyword>
  <keyword>Lennox-Gastaut Syndrome</keyword>
  <keyword>Dravet Syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberous Sclerosis</mesh_term>
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Epilepsies, Myoclonic</mesh_term>
    <mesh_term>Lennox Gastaut Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cannabidiol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04485104
org study id: GWEP17005
secondary id: 2020-002132-67
nct id: NCT04485104
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of
      adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC),
      Lennox-Gastaut syndrome (LGS), or Dravet syndrome (DS).
The study duration will be up to approximately 62 weeks, including a 4-week
      screening/baseline period, a 52-week dose optimization treatment period (which includes a
      fixed 2-week titration period followed by flexible dose optimization), a 10-day taper period,
      and a safety follow-up period (4 weeks after the end-of-taper visit).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Mean Change From Baseline in Blood Pressure
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Mean Change From Baseline in Pulse Rate
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Mean Change From Baseline in Respiration Rate
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Mean Change from Baseline in Body Temperature
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Mean Change From Baseline in Height
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Mean Change From Baseline in Body Weight
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Mean Change From Baseline in Heart Rate
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Mean Change From Baseline in RR Interval
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Mean Change From Baseline in PR Interval
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Mean Change From Baseline in QRS Duration
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Mean Change From Baseline in QT Interval
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Mean Change From Baseline in QTcB and QTcF
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Number of Participants with a Clinically Significant Change in Laboratory Parameters
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Number of Participants with Emergence of New Types of Seizures
time frame: From signing of informed consent up to the post-treatment safety follow-up visit; up to 62 Weeks
measure: Plasma Concentrations of GWP42003-P and its Major Metabolites
time frame: Predose, 3 hours and 6 hours post dose on Days 1, 15, 29, 57, and End of Treatment (Week 52)
measure: Percentage Change from Baseline in Indication-Specific Total Countable Seizures as Recorded by Caregivers and Investigators
time frame: Week 12, and every 4 weeks thereafter, up to Week 52
measure: Number of Treatment Responders
time frame: Week 12, and every 4 weeks thereafter, up to Week 52
description: Treatment Responders are defined as participants with ≥ 50% reduction from baseline in caregiver- and Investigator-Reported total countable seizures
measure: Percentage Change from Baseline in Total Countable Seizures
time frame: Week 12, and every 4 weeks thereafter, up to Week 52
description: This endpoint includes the following changes in percentage of seizures:
> 25% (increase);
≥ 0% to ≤ 25% (increase);
> -25% to < 0% (reduction);
> -50% to ≤ -25% (reduction);
> -75% to ≤ -50% (reduction);
≤ -75% (reduction).
measure: Number of Participants Who Achieved Seizure-Free Status
time frame: Week 12, and every 4 weeks thereafter, up to Week 52
measure: Percentage of Participants Still Receiving GWP42003-P
time frame: Week 12, and every 4 weeks thereafter, up to Week 52
arm group label: GWP42003-P
arm group type: Experimental
description: The 52-week treatment period includes a fixed 2-week titration schedule followed by flexible dose optimization.
Day 1: 5 mg/kg/day (2.5 mg/kg twice daily (b.i.d.))
Day 8: 10 mg/kg/day (5 mg/kg b.i.d.)
Day 15 to Week 52: Flexible dosing based on the participant's observed efficacy, safety, and tolerability per the investigator's clinical judgement. Up to a maximum of 20 mg/kg/day (10 mg/kg b.i.d.) for LGS and DS or 25 mg/kg/day (12.5 mg/kg b.i.d.) for TSC, in maximum weekly increments of 5 mg/kg/day (≤ 2.5 mg/kg b.i.d.).
intervention type: Drug
intervention name: GWP42003-P
description: Oral Solution
arm group label: GWP42003-P
other name: Cannabidiol
other name: Epidiolex
other name: Epidyolex
criteria: 
gender: All
minimum age: 1 Month
maximum age: 23 Months
healthy volunteers: No
last name: Clinical Trial Disclosure & Transparency
phone: 215-832-3750
email: ClinicalTrialDisclosure@JazzPharma.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Tuberous Sclerosis
mesh term: Seizures
mesh term: Epilepsies, Myoclonic
mesh term: Lennox Gastaut Syndrome
mesh term: Syndrome
mesh term: Sclerosis
mesh term: Cannabidiol
sharing ipd: No