<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/NCT04451668</url>
  </required_header>
  <id_info>
    <org_study_id>CLFT218-1901</org_study_id>
    <nct_id>NCT04451668</nct_id>
  </id_info>
  <brief_title>An Open Label Study of FT218 in Subjects With Narcolepsy</brief_title>
  <acronym>RESTORE</acronym>
  <official_title>Open Label Study of Safety/Tolerability of Once Nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy Patients That Have and Have Not Been Previously Maintained on Twice-nightly Sodium Oxybate IR</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Avadel</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Avadel</source>
  <oversight_info>
    <has_dmc>No</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>
      An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly&#xD;
      Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to&#xD;
      switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for the&#xD;
      Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will enroll subjects with narcolepsy, either NT1 or NT2, who completed the FT218&#xD;
      Phase 3 REST-ON study or eligible subjects with narcolepsy currently receiving a stable dose&#xD;
      of twice nightly sodium oxybate IR or mixed salts oxybate (regardless of whether they&#xD;
      participated in the REST-ON study), or subjects who are naïve to oxybate therapy (i.e.,&#xD;
      FT218, twice nightly sodium oxybate IR or mixed salts oxybate). Following a screening period,&#xD;
      subjects who meet the entry criteria will be enrolled into the study. Subjects who completed&#xD;
      the FT218 Phase 3 REST-ON study will initiate treatment with FT218 at 4.5 g and will follow a&#xD;
      titration schedule up to the highest tolerate dose (up to 9 g), or the dose deemed effective&#xD;
      by the investigator. Subjects previously maintained on twice nightly sodium oxybate IR will&#xD;
      initiate FT218 treatment at a dose equivalent or closest to the total gram dose of&#xD;
      twice-nightly sodium oxybate IR and then titrate up or down, in accord with safety and&#xD;
      effectiveness as determined by the investigator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Open label treatment with FT218 (once nightly sodium oxybate extended release)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of treatment-related adverse events</measure>
    <time_frame>24 months</time_frame>
    <description>Assess the long-term safety and tolerability of FT218 by the number of participants experiencing treatment-related adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of clinically significant changes in vital signs</measure>
    <time_frame>24 months</time_frame>
    <description>Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in vital signs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of clinically significant changes in laboratory test results</measure>
    <time_frame>24 months</time_frame>
    <description>Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in laboratory test results</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">175</enrollment>
  <condition>Narcolepsy</condition>
  <condition>Cataplexy</condition>
  <condition>Excessive Daytime Somnolence</condition>
  <condition>Sleep Disorder</condition>
  <condition>Sleep Disturbance</condition>
  <condition>Sleep Wake Disorders</condition>
  <arm_group>
    <arm_group_label>FT218</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>once nightly sodium oxybate extended release oral solution (FT218)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FT218</intervention_name>
    <description>once nightly sodium oxybate extended release</description>
    <arm_group_label>FT218</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects receiving a stable doses of twice-nightly sodium oxybate IR or mixed salts&#xD;
             oxybate for at least 4 weeks and are willing to switch to FT218&#xD;
&#xD;
          -  Subjects who completed the CLFT218-1501 REST-ON Study in a compliant manner and for&#xD;
             whom the Investigator determines would receive benefit from treatment with FT218 and&#xD;
             have not started treatment with twice nightly sodium oxybate IR or mixed salts oxybate&#xD;
&#xD;
          -  Are treatment naïve to any oxybate therapy (i.e. FT218, twice nightly sodium oxybate&#xD;
             IR or mixed salts oxybate)&#xD;
&#xD;
          -  Subjects have a diagnosis of narcolepsy, either confirmed prior to the REST-ON study&#xD;
             or as confirmed by the Investigator as defined by the International Classification of&#xD;
             Sleep Disorders 3 criteria (AASM 2014)&#xD;
&#xD;
          -  Willing and able to give written informed consent for study participation. Young&#xD;
             adults (16 and 17 years old) who have not reached the age of majority must be capable&#xD;
             of giving assent in addition to consent from a legally authorized guardian, as&#xD;
             required by local laws and regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects that terminated the CLFT218-1501 REST-ON Study prior to completing Visit 8&#xD;
&#xD;
          -  Any use of the following medications during the study: Anticonvulsants, Clonidine,&#xD;
             Hypnotics, Anxiolytics, Sedating antihistamines, Antipsychotics, Other experimental&#xD;
             medications designed to treat narcolepsy, cataplexy or any other condition, or other&#xD;
             medications with significant sedating effects/CNS depressant effects are prohibited&#xD;
             for REST-ON and naive patients. Patients on twice nightly sodium oxybate IR on&#xD;
             medications in classes listed above may be eligible for enrollment if the subject has&#xD;
             been on a stable dose of the prohibited medication in combination with a stable dose&#xD;
             of twice nightly sodium oxybate or mixed salts oxybate for at least three months and&#xD;
             has demonstrated no AEs, intolerance, or interactions AND is approved to participate&#xD;
             by the Medical Monitor. Sedative hypnotics are prohibited regardless.)&#xD;
&#xD;
          -  A diagnosis of sleep apnea where AHI is ≥15 and/or current use of CPAP or other&#xD;
             devices for sleep apnea.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sleep Disorders Center of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Sleep Medicine</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SDS Clinical Trials</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alpine Clinical Research Center</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delta Waves, Inc.</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80918</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonary Disease Specialists, PA</name>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <zip>34741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sleep Medicine Specialists of South Florida</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FL Pediatric Research Institute</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroTrials Research Inc</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SleepCare Research Institute, Inc. d/b/a Clinical Research Institute</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fort Wayne Neurological</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helene A. Emsellem, MD PC</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baystate Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Hospital - Sleep Medicine and Research Center</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Sleep-Wake Disorders Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Respiratory and Sleep Medicine</name>
      <address>
        <city>Huntersville</city>
        <state>North Carolina</state>
        <zip>28078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sleep Management Institute Intrepid Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45245</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Sleep Medicine Institute</name>
      <address>
        <city>Dublin</city>
        <state>Ohio</state>
        <zip>43017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brian Abaluck Sleep Medicine</name>
      <address>
        <city>Malvern</city>
        <state>Pennsylvania</state>
        <zip>19355</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bogan Sleep Consultants, LLC</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FutureSearch Trials of Neurology</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sleep Therapy &amp; Research Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229-4849</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Sleep Medicine Associates</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Houston Neurology</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TPMG Clinical Research Williamsburg</name>
      <address>
        <city>Williamsburg</city>
        <state>Virginia</state>
        <zip>23188</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Perry Sound Health Center</name>
      <address>
        <city>Parry Sound</city>
        <state>Ontario</state>
        <zip>P2A 3A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jodha Tishon Inc.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 3A3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 10, 2022</last_update_submitted>
  <last_update_submitted_qc>June 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 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>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Narcolepsy</mesh_term>
    <mesh_term>Cataplexy</mesh_term>
    <mesh_term>Disorders of Excessive Somnolence</mesh_term>
    <mesh_term>Sleepiness</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/NCT04451668
org study id: CLFT218-1901
nct id: NCT04451668
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly
      Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to
      switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for the
      Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy
This study will enroll subjects with narcolepsy, either NT1 or NT2, who completed the FT218
      Phase 3 REST-ON study or eligible subjects with narcolepsy currently receiving a stable dose
      of twice nightly sodium oxybate IR or mixed salts oxybate (regardless of whether they
      participated in the REST-ON study), or subjects who are naïve to oxybate therapy (i.e.,
      FT218, twice nightly sodium oxybate IR or mixed salts oxybate). Following a screening period,
      subjects who meet the entry criteria will be enrolled into the study. Subjects who completed
      the FT218 Phase 3 REST-ON study will initiate treatment with FT218 at 4.5 g and will follow a
      titration schedule up to the highest tolerate dose (up to 9 g), or the dose deemed effective
      by the investigator. Subjects previously maintained on twice nightly sodium oxybate IR will
      initiate FT218 treatment at a dose equivalent or closest to the total gram dose of
      twice-nightly sodium oxybate IR and then titrate up or down, in accord with safety and
      effectiveness as determined by the investigator.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open label treatment with FT218 (once nightly sodium oxybate extended release)
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of treatment-related adverse events
time frame: 24 months
description: Assess the long-term safety and tolerability of FT218 by the number of participants experiencing treatment-related adverse events
measure: Incidence of clinically significant changes in vital signs
time frame: 24 months
description: Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in vital signs
measure: Incidence of clinically significant changes in laboratory test results
time frame: 24 months
description: Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in laboratory test results
arm group label: FT218
arm group type: Experimental
description: once nightly sodium oxybate extended release oral solution (FT218)
intervention type: Drug
intervention name: FT218
description: once nightly sodium oxybate extended release
arm group label: FT218
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Dyssomnias
mesh term: Narcolepsy
mesh term: Cataplexy
mesh term: Disorders of Excessive Somnolence
mesh term: Sleepiness