<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/NCT03778424</url>
  </required_header>
  <id_info>
    <org_study_id>E2080-E044-501</org_study_id>
    <nct_id>NCT03778424</nct_id>
  </id_info>
  <brief_title>An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303</brief_title>
  <official_title>An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <brief_summary>
    <textblock>
      This is an extended access study for participants who have completed Rufinamide Study&#xD;
      E2080-G000-303 to continue to have access to rufinamide until it becomes commercially&#xD;
      available in Poland or until no participants remain in the EAP.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
    <expanded_access_type_treatment>Yes</expanded_access_type_treatment>
  </expanded_access_info>
  <condition>Lennox Gastaut Syndrome</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rufinamide</intervention_name>
    <description>Rufinamide up to 45 milligram per kilogram per day (mg/kg/day).</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who were on rufinamide treatment and have completed Study E2080-G000-303&#xD;
             in Poland.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants were randomized to the other antiepileptic drug (AED) treatment group in&#xD;
             study E2080-G000-303.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Eisai Medical Information</last_name>
    <phone>1-888-274-2378</phone>
    <email>esi_medinfo@eisai.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Generała Tadeusza Kościuszki 52</name>
      <address>
        <city>Kielce</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Available</status>
  </location>
  <location>
    <facility>
      <name>Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu</name>
      <address>
        <city>Poznań</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Available</status>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 5, 2023</last_update_submitted>
  <last_update_submitted_qc>May 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Central Nervous System</keyword>
  <keyword>E2080</keyword>
  <keyword>Rufinamide</keyword>
  <keyword>Epilepsy</keyword>
  <keyword>Seizures</keyword>
  <keyword>Brain Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lennox Gastaut Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rufinamide</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/NCT03778424
org study id: E2080-E044-501
nct id: NCT03778424
lead sponsor: 
This is an extended access study for participants who have completed Rufinamide Study
      E2080-G000-303 to continue to have access to rufinamide until it becomes commercially
      available in Poland or until no participants remain in the EAP.
expanded access type individual: Yes
expanded access type treatment: Yes
intervention type: Drug
intervention name: Rufinamide
description: Rufinamide up to 45 milligram per kilogram per day (mg/kg/day).
criteria: 
gender: All
minimum age: 4 Years
maximum age: N/A
last name: Eisai Medical Information
phone: 1-888-274-2378
email: esi_medinfo@eisai.com
facility: 
status: Available
facility: 
status: Available
country: Poland
responsible party type: Sponsor
mesh term: Lennox Gastaut Syndrome
mesh term: Syndrome
mesh term: Rufinamide