<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/NCT04437004</url>
  </required_header>
  <id_info>
    <org_study_id>ZX008-1800</org_study_id>
    <nct_id>NCT04437004</nct_id>
  </id_info>
  <brief_title>Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)</brief_title>
  <acronym>Dravet</acronym>
  <official_title>Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <brief_summary>
    <textblock>
      The purpose of this research study is to (1) provide access to fenfluramine for patients with&#xD;
      intractable epilepsy associated with Dravet syndrome, and (2) evaluate the safety of&#xD;
      fenfluramine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research study is to (1) provide access to fenfluramine for patients with&#xD;
      intractable epilepsy associated with Dravet syndrome, and (2) evaluate the safety of&#xD;
      fenfluramine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Available</overall_status>
  <study_type>Expanded Access</study_type>
  <expanded_access_info>
    <expanded_access_type_treatment>Yes</expanded_access_type_treatment>
  </expanded_access_info>
  <condition>Dravet Syndrome</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fenfluramine</intervention_name>
    <description>The treatment plan for this Expanded Access Protocol is for patients with Dravet syndrome who do not qualify for participation in one of the ongoing ZX008 (fenfluramine hydrochloride) clinical trials.</description>
    <other_name>Fenfluramine Hydrochloride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all&#xD;
             available medications for seizures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Angela Martinez</last_name>
    <phone>310-206-4037</phone>
    <email>angelamartinez@mednet.ucla.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095-1752</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Available</status>
    <contact>
      <last_name>Shaun Hussain, MD</last_name>
      <phone>310-206-4037</phone>
    </contact>
    <contact_backup>
      <last_name>Angela L. Martinez</last_name>
      <phone>310-206-4037</phone>
      <email>angelamartinez@mednet.ucla.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>February 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Shaun Hussain, MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsies, Myoclonic</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fenfluramine</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/NCT04437004
org study id: ZX008-1800
nct id: NCT04437004
lead sponsor: 
The purpose of this research study is to (1) provide access to fenfluramine for patients with
      intractable epilepsy associated with Dravet syndrome, and (2) evaluate the safety of
      fenfluramine.
The purpose of this research study is to (1) provide access to fenfluramine for patients with
      intractable epilepsy associated with Dravet syndrome, and (2) evaluate the safety of
      fenfluramine.
expanded access type treatment: Yes
intervention type: Drug
intervention name: Fenfluramine
description: The treatment plan for this Expanded Access Protocol is for patients with Dravet syndrome who do not qualify for participation in one of the ongoing ZX008 (fenfluramine hydrochloride) clinical trials.
other name: Fenfluramine Hydrochloride
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
last name: Angela Martinez
phone: 310-206-4037
email: angelamartinez@mednet.ucla.edu
facility: 
status: Available
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Shaun Hussain, MD
investigator title: Associate Professor
mesh term: Epilepsies, Myoclonic
mesh term: Syndrome
mesh term: Fenfluramine