<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/NCT04457687</url>
  </required_header>
  <id_info>
    <org_study_id>E2023-A001-405</org_study_id>
    <nct_id>NCT04457687</nct_id>
  </id_info>
  <brief_title>Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies</brief_title>
  <official_title>Extended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory Epilepsies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to provide continued access of lorcaserin to&#xD;
      participants with Dravet syndrome and other refractory epilepsies.&#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_intermediate>Yes</expanded_access_type_intermediate>
  </expanded_access_info>
  <condition>Epilepsies, Myoclonic</condition>
  <condition>Drug Resistant Epilepsy</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lorcaserin</intervention_name>
    <description>Lorcaserin 10 milligram (mg) tablets orally.</description>
    <other_name>E2023</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Confirmed diagnosis of Dravet syndrome (according to Recommendation from a North&#xD;
             American Consensus Panel, 2017) or other refractory epilepsy (per the judgment of the&#xD;
             treating physician)&#xD;
&#xD;
          2. Male or female, age at least 2 years at the time of informed consent&#xD;
&#xD;
          3. Currently treated with lorcaserin, that the treatment is for Dravet syndrome or other&#xD;
             refractory epilepsies, and the treatment was initiated before 13 Feb 2020; or has&#xD;
             completed Study E2023-A001-304&#xD;
&#xD;
          4. Has a clinical benefit from lorcaserin in the opinion of the treating physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 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>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Extended Access Program</keyword>
  <keyword>Expanded Access Program</keyword>
  <keyword>Dravet Syndrome</keyword>
  <keyword>Refractory Epilepsies</keyword>
  <keyword>Lorcaserin</keyword>
  <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>
    <mesh_term>Epilepsies, Myoclonic</mesh_term>
  </condition_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/NCT04457687
org study id: E2023-A001-405
nct id: NCT04457687
lead sponsor: 
The primary purpose of this study is to provide continued access of lorcaserin to
      participants with Dravet syndrome and other refractory epilepsies.
expanded access type intermediate: Yes
intervention type: Drug
intervention name: Lorcaserin
description: Lorcaserin 10 milligram (mg) tablets orally.
other name: E2023
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
last name: Eisai Medical Information
phone: +1-888-274-2378
email: esi_medinfo@eisai.com
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Drug Resistant Epilepsy
mesh term: Epilepsies, Myoclonic