<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/NCT03780127</url>
  </required_header>
  <id_info>
    <org_study_id>ZX008-1800</org_study_id>
    <nct_id>NCT03780127</nct_id>
  </id_info>
  <brief_title>ZX008 Expanded Access Protocol</brief_title>
  <official_title>ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zogenix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UCB Pharma</source>
  <brief_summary>
    <textblock>
      The treatment plan for this Expanded Access Protocol is for patients with Dravet syndrome who&#xD;
      do not qualify for participation in one of the ongoing ZX008 clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treatment plan consists of an up to 24-month Treatment Period. Access is via application&#xD;
      by your health care provider and available at one of the Expanded Access treatment centers.&#xD;
      The dose of ZX008 for the duration of the Treatment Period will range from 0.2 mg/kg/day to a&#xD;
      maximum of 0.8 mg/kg/day, not to exceed a total daily dose of 30 mg/day; for patients&#xD;
      concurrently being prescribed stiripentol, the maximum will be 0.5mg/kg/day, not to exceed a&#xD;
      total daily dose of 20 mg/day.&#xD;
&#xD;
      The fenfluramine US Expanded Access Program (US EAP) is available to full-time US Residents&#xD;
      only.&#xD;
&#xD;
      Participation in the US EAP is limited to patients currently residing in the US. Residency in&#xD;
      the US must be for the duration of participation in the US EAP. Drug may not be shipped&#xD;
      outside the US.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Approved for marketing</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <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 Hydrochloride</intervention_name>
    <description>ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with KD.</description>
    <other_name>ZX008</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is male or female, age 2 years and older, inclusive as of Study Day 1.&#xD;
&#xD;
          -  Patient is diagnosed with Dravet syndrome.&#xD;
&#xD;
          -  Patient is experiencing convulsive seizures which are not controlled by current AEDs.&#xD;
&#xD;
          -  Patient is receiving at least one AED and will remain on at least one AED for the&#xD;
             duration of treatment.&#xD;
&#xD;
          -  Patient has been approved for inclusion by Zogenix.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient requires or starts using an unacceptable or contraindicated concomitant&#xD;
             medication.&#xD;
&#xD;
          -  Patient has valvulopathy.&#xD;
&#xD;
          -  Patient is at risk for pulmonary hypertension.&#xD;
&#xD;
          -  Patient exclusion will be at the sole discretion of the Sponsor.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03780127
org study id: ZX008-1800
nct id: NCT03780127
lead sponsor: 
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 clinical trials.
The treatment plan consists of an up to 24-month Treatment Period. Access is via application
      by your health care provider and available at one of the Expanded Access treatment centers.
      The dose of ZX008 for the duration of the Treatment Period will range from 0.2 mg/kg/day to a
      maximum of 0.8 mg/kg/day, not to exceed a total daily dose of 30 mg/day; for patients
      concurrently being prescribed stiripentol, the maximum will be 0.5mg/kg/day, not to exceed a
      total daily dose of 20 mg/day.

      The fenfluramine US Expanded Access Program (US EAP) is available to full-time US Residents
      only.

      Participation in the US EAP is limited to patients currently residing in the US. Residency in
      the US must be for the duration of participation in the US EAP. Drug may not be shipped
      outside the US.
expanded access type treatment: Yes
intervention type: Drug
intervention name: Fenfluramine Hydrochloride
description: ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with KD.
other name: ZX008
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
responsible party type: Sponsor
mesh term: Epilepsies, Myoclonic
mesh term: Syndrome
mesh term: Fenfluramine