<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/NCT02231008</url>
  </required_header>
  <id_info>
    <org_study_id>VP-VEC-162-2401</org_study_id>
    <nct_id>NCT02231008</nct_id>
  </id_info>
  <brief_title>Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS</brief_title>
  <official_title>A Double-blind, Randomized, Two-period Crossover Study Evaluating the Effects of Tasimelteon vs. Placebo on Sleep Disturbances of Individuals With Smith-Magenis Syndrome (SMS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanda Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanda Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of&#xD;
      individuals with Smith-Magenis Syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">January 2022</completion_date>
  <primary_completion_date type="Actual">November 19, 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters</measure>
    <time_frame>9 Weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability as measured by spontaneous reporting of adverse events (AEs).</measure>
    <time_frame>up to 137 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Smith-Magenis Syndrome</condition>
  <condition>Circadian</condition>
  <arm_group>
    <arm_group_label>Tasimelteon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose oral capsule or equivalent age-appropriate oral formulation, daily dosage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo comparator</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tasimelteon</intervention_name>
    <arm_group_label>Tasimelteon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A confirmed clinical diagnosis of SMS&#xD;
&#xD;
          2. Informed consent from the patient or the legal guardian&#xD;
&#xD;
          3. Male or female between the ages of 3- 65 years of age&#xD;
&#xD;
          4. Recent history of sleep disturbances&#xD;
&#xD;
          5. Have an appointed care-giver complete the required outpatient assessments&#xD;
&#xD;
          6. Willing and able to comply with study requirements and restrictions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to dose daily with medication&#xD;
&#xD;
          2. Exposure to any investigational drug, including placebo, within 30 days or 5&#xD;
             half-lives (whichever was longer) of screening&#xD;
&#xD;
          3. Any other sound medical reason as determined by the clinical investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>November 15, 2022</last_update_submitted>
  <last_update_submitted_qc>November 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SMS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Smith-Magenis Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT02231008
org study id: VP-VEC-162-2401
nct id: NCT02231008
lead sponsor: 
has dmc: No
The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of
      individuals with Smith-Magenis Syndrome.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters
time frame: 9 Weeks
measure: Safety and tolerability as measured by spontaneous reporting of adverse events (AEs).
time frame: up to 137 weeks
arm group label: Tasimelteon
arm group type: Experimental
description: Single dose oral capsule or equivalent age-appropriate oral formulation, daily dosage
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo comparator
intervention type: Drug
intervention name: tasimelteon
arm group label: Tasimelteon
intervention type: Drug
intervention name: placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 3 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dyssomnias
mesh term: Parasomnias
mesh term: Smith-Magenis Syndrome
mesh term: Syndrome