<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/NCT03299842</url>
  </required_header>
  <id_info>
    <org_study_id>ZX008-1503-SS01</org_study_id>
    <nct_id>NCT03299842</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome</brief_title>
  <official_title>An Exploratory, Pilot Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome: A Sub-study to the ZX008-1503 Open-Label Extension Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zogenix, Inc.</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 is a sub-study to ZX008-1503. Subjects will be fitted with an Embrace seizure detection&#xD;
      watch and seizures detected by the watch will be compared to those entered into an electronic&#xD;
      seizure diary.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This sub study will include up to 20 participants who meet the entry criteria for the main&#xD;
      Study ZX008-1503 and who are willing to wear the Embrace watch and use the Embrace Alert app&#xD;
      for 12 consecutive weeks. Those invited to participate will undergo all procedures included&#xD;
      in the main study during their participation in this sub-study,&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>
    <intervention_model_description>ZX008-1503 Fenfluramine, open-label</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usability of the Empatica Embrace Seizure Detection watch system (Embrace) in outpatients with Dravet syndrome</measure>
    <time_frame>12 weeks with the option to extend to 24 weeks</time_frame>
    <description>Caregiver burden as measured by the Perceived Stress Scale Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Usability of the Empatica Embrace Seizure Detection watch system (Embrace) in outpatients with Dravet syndrome</measure>
    <time_frame>12 weeks with the option to extend to 24 weeks</time_frame>
    <description>User experience as measured by the 5-point Likert Ease of Use Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare objective convulsive seizure count, as captured by the Embrace, to convulsive seizure count captured manually in the Embrace electronic seizure diary</measure>
    <time_frame>12 weeks with the option to extend to 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Dravet Syndrome</condition>
  <arm_group>
    <arm_group_label>ZX008</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ZX008 is supplied as an oral solution in a concentration of 2.5 mg/mL. Subjects will be titrated to an effective dose beginning with 0.2 mg/kg/day (maximum: 30 mg/day).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ZX008 (Fenfluramine Hydrochloride)</intervention_name>
    <description>ZX008 is supplied as an oral solution in a concentration of 2.5 mg/mL. Subjects will be titrated to an effective dose beginning with 0.2 mg/kg/day (maximum: 30 mg/day).</description>
    <arm_group_label>ZX008</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is willing to wear the Embrace watch on the wrist (alternatively ankle, if&#xD;
             needed for younger children). Subjects are asked to wear the watch for as many hours&#xD;
             of the day as possible and for the entire night, if possible, for the duration of the&#xD;
             sub-study.&#xD;
&#xD;
          -  Subject's parent/caregiver is willing to use the Alert App.&#xD;
&#xD;
          -  Subject/subject's caregiver is willing to ensure that the Embrace watch remains within&#xD;
             close proximity of the paired iPod Touch running the Empatica Alert app.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a known hypersensitivity to any of the Embrace device materials.&#xD;
&#xD;
          -  Subject has a clinically significant condition, or has had clinically relevant&#xD;
             symptoms or a clinically significant illness in the 4 weeks prior to Visit 1, other&#xD;
             than epilepsy, that would negatively impact study participation, collection of study&#xD;
             data, or pose a risk to the subject.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>October 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>June 11, 2019</last_update_submitted>
  <last_update_submitted_qc>June 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>seizure</keyword>
  <keyword>tonic clonic</keyword>
  <keyword>epilepsy</keyword>
  <keyword>myoclonic</keyword>
  <keyword>encephalopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seizures</mesh_term>
    <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/NCT03299842
org study id: ZX008-1503-SS01
nct id: NCT03299842
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a sub-study to ZX008-1503. Subjects will be fitted with an Embrace seizure detection
      watch and seizures detected by the watch will be compared to those entered into an electronic
      seizure diary.
This sub study will include up to 20 participants who meet the entry criteria for the main
      Study ZX008-1503 and who are willing to wear the Embrace watch and use the Embrace Alert app
      for 12 consecutive weeks. Those invited to participate will undergo all procedures included
      in the main study during their participation in this sub-study,
allocation: N/A
intervention model: Single Group Assignment
intervention model description: ZX008-1503 Fenfluramine, open-label
primary purpose: Treatment
masking: None (Open Label)
measure: Usability of the Empatica Embrace Seizure Detection watch system (Embrace) in outpatients with Dravet syndrome
time frame: 12 weeks with the option to extend to 24 weeks
description: Caregiver burden as measured by the Perceived Stress Scale Questionnaire
measure: Overall Usability of the Empatica Embrace Seizure Detection watch system (Embrace) in outpatients with Dravet syndrome
time frame: 12 weeks with the option to extend to 24 weeks
description: User experience as measured by the 5-point Likert Ease of Use Questionnaire
measure: Compare objective convulsive seizure count, as captured by the Embrace, to convulsive seizure count captured manually in the Embrace electronic seizure diary
time frame: 12 weeks with the option to extend to 24 weeks
arm group label: ZX008
arm group type: Experimental
description: ZX008 is supplied as an oral solution in a concentration of 2.5 mg/mL. Subjects will be titrated to an effective dose beginning with 0.2 mg/kg/day (maximum: 30 mg/day).
intervention type: Drug
intervention name: ZX008 (Fenfluramine Hydrochloride)
description: ZX008 is supplied as an oral solution in a concentration of 2.5 mg/mL. Subjects will be titrated to an effective dose beginning with 0.2 mg/kg/day (maximum: 30 mg/day).
arm group label: ZX008
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Seizures
mesh term: Epilepsies, Myoclonic
mesh term: Syndrome
mesh term: Fenfluramine