<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/NCT03291041</url>
  </required_header>
  <id_info>
    <org_study_id>VP-VEC-162-2102</org_study_id>
    <nct_id>NCT03291041</nct_id>
  </id_info>
  <brief_title>A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder</brief_title>
  <official_title>A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder</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>
      A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With&#xD;
      Jet Lag Disorder&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted</measure>
    <time_frame>4 days</time_frame>
    <description>Measured using polysomnography (PSG) and analyzed as change from baseline. Examination of the observational phase baseline data demonstrated that Night 3 was the night most disrupted.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Severity (PGI-S) Day 4</measure>
    <time_frame>1 Day</time_frame>
    <description>Self-reported global index measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The PGI-S is a single question asking the subject to rate their jet-lag condition at the present time on a scale of 1 &quot;Normal&quot; to 4 &quot;Severe&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights)</measure>
    <time_frame>3 Days</time_frame>
    <description>Measured using polysomnography (PSG) and analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Total Sleep Time on Night 3</measure>
    <time_frame>1 Day</time_frame>
    <description>Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Sleep Quality Night 3</measure>
    <time_frame>1 Day</time_frame>
    <description>Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline. Sleep quality was ranked from 1 &quot;Poor&quot; to 5 &quot;Excellent&quot; and was the subscale of the post-sleep questionnaire used to determine subjective sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Sleep Latency Night 3</measure>
    <time_frame>1 Day</time_frame>
    <description>Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Wake After Sleep Onset Night 3</measure>
    <time_frame>1 Day</time_frame>
    <description>Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Karolinska Sleepiness Scale Day 4</measure>
    <time_frame>1 Day</time_frame>
    <description>Self-reported fatigue measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The KSS is a single question asking the subject to rate how sleepy they feel at that moment on a 9-point scale where 1 = extremely awake and 9 = extremely sleepy/fighting to stay wake.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Jet Lag Disorder</condition>
  <arm_group>
    <arm_group_label>tasimelteon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tasimelteon, administered as oral capsule(s)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, administered as oral capsule(s)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tasimelteon</intervention_name>
    <description>capsule</description>
    <arm_group_label>tasimelteon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>capsule</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability and acceptance to provide written consent&#xD;
&#xD;
          -  Men or women between 18-75 years&#xD;
&#xD;
          -  Body Mass Index of ≥ 18 and ≤ 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History (within the 12 months prior to screening) of psychiatric disorders&#xD;
&#xD;
          -  Major surgery, trauma, illness or immobile for 3 or more days within the past month&#xD;
&#xD;
          -  Pregnancy or recent pregnancy (within 6 weeks)&#xD;
&#xD;
          -  A positive test for drugs of abuse at the screening visit&#xD;
&#xD;
          -  Any other sound medical reason as determined by the clinical investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Alameda</city>
        <state>California</state>
        <zip>94501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>September 8, 2016</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <results_first_submitted>September 25, 2020</results_first_submitted>
  <results_first_submitted_qc>October 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 3, 2021</results_first_posted>
  <last_update_submitted>October 5, 2021</last_update_submitted>
  <last_update_submitted_qc>October 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2021</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>Jet Lag Syndrome</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03291041/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tasimelteon</title>
          <description>tasimelteon, administered as oral capsule(s)&#xD;
Tasimelteon: capsule</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo, administered as oral capsule(s)&#xD;
Placebo: capsule</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tasimelteon</title>
          <description>tasimelteon, administered as oral capsule(s)&#xD;
Tasimelteon: capsule</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo, administered as oral capsule(s)&#xD;
Placebo: capsule</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.3" spread="13.47"/>
                    <measurement group_id="B2" value="48.2" spread="16.06"/>
                    <measurement group_id="B3" value="49.8" spread="14.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted</title>
        <description>Measured using polysomnography (PSG) and analyzed as change from baseline. Examination of the observational phase baseline data demonstrated that Night 3 was the night most disrupted.</description>
        <time_frame>4 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tasimelteon</title>
            <description>tasimelteon, administered as oral capsule(s)&#xD;
Tasimelteon: capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, administered as oral capsule(s)&#xD;
Placebo: capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted</title>
          <description>Measured using polysomnography (PSG) and analyzed as change from baseline. Examination of the observational phase baseline data demonstrated that Night 3 was the night most disrupted.</description>
          <units>minutes</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.2" spread="11.213"/>
                    <measurement group_id="O2" value="41.4" spread="11.882"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.</non_inferiority_desc>
            <p_value>0.0354</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>34.75</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression of Severity (PGI-S) Day 4</title>
        <description>Self-reported global index measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The PGI-S is a single question asking the subject to rate their jet-lag condition at the present time on a scale of 1 &quot;Normal&quot; to 4 &quot;Severe&quot;.</description>
        <time_frame>1 Day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tasimelteon</title>
            <description>tasimelteon, administered as oral capsule(s)&#xD;
Tasimelteon: capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, administered as oral capsule(s)&#xD;
Placebo: capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression of Severity (PGI-S) Day 4</title>
          <description>Self-reported global index measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The PGI-S is a single question asking the subject to rate their jet-lag condition at the present time on a scale of 1 &quot;Normal&quot; to 4 &quot;Severe&quot;.</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.71" spread="0.174"/>
                    <measurement group_id="O2" value="-0.07" spread="0.183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.</non_inferiority_desc>
            <p_value>0.0168</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.63</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights)</title>
        <description>Measured using polysomnography (PSG) and analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight.</description>
        <time_frame>3 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tasimelteon</title>
            <description>tasimelteon, administered as oral capsule(s)&#xD;
Tasimelteon: capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, administered as oral capsule(s)&#xD;
Placebo: capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights)</title>
          <description>Measured using polysomnography (PSG) and analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight.</description>
          <units>Minutes</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131.4" spread="35.243"/>
                    <measurement group_id="O2" value="40.9" spread="37.774"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.</non_inferiority_desc>
            <p_value>0.0785</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>90.56</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Total Sleep Time on Night 3</title>
        <description>Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline</description>
        <time_frame>1 Day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tasimelteon</title>
            <description>tasimelteon, administered as oral capsule(s)&#xD;
Tasimelteon: capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, administered as oral capsule(s)&#xD;
Placebo: capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Total Sleep Time on Night 3</title>
          <description>Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline</description>
          <units>Minutes</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111.9" spread="23.012"/>
                    <measurement group_id="O2" value="33.47" spread="24.555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.</non_inferiority_desc>
            <p_value>0.0225</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>78.45</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Sleep Quality Night 3</title>
        <description>Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline. Sleep quality was ranked from 1 &quot;Poor&quot; to 5 &quot;Excellent&quot; and was the subscale of the post-sleep questionnaire used to determine subjective sleep quality.</description>
        <time_frame>1 Day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tasimelteon</title>
            <description>tasimelteon, administered as oral capsule(s)&#xD;
Tasimelteon: capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, administered as oral capsule(s)&#xD;
Placebo: capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Sleep Quality Night 3</title>
          <description>Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline. Sleep quality was ranked from 1 &quot;Poor&quot; to 5 &quot;Excellent&quot; and was the subscale of the post-sleep questionnaire used to determine subjective sleep quality.</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.31" spread="0.273"/>
                    <measurement group_id="O2" value="0.36" spread="0.290"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.</non_inferiority_desc>
            <p_value>0.0198</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.95</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Sleep Latency Night 3</title>
        <description>Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline</description>
        <time_frame>1 Day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tasimelteon</title>
            <description>tasimelteon, administered as oral capsule(s)&#xD;
Tasimelteon: capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, administered as oral capsule(s)&#xD;
Placebo: capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Sleep Latency Night 3</title>
          <description>Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline</description>
          <units>Minutes</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.6" spread="8.39"/>
                    <measurement group_id="O2" value="6.0" spread="8.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.</non_inferiority_desc>
            <p_value>0.0347</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-26.55</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Wake After Sleep Onset Night 3</title>
        <description>Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline</description>
        <time_frame>1 Day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tasimelteon</title>
            <description>tasimelteon, administered as oral capsule(s)&#xD;
Tasimelteon: capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, administered as oral capsule(s)&#xD;
Placebo: capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Wake After Sleep Onset Night 3</title>
          <description>Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline</description>
          <units>Minutes</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-81.1" spread="22.53"/>
                    <measurement group_id="O2" value="-24.7" spread="24.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.</non_inferiority_desc>
            <p_value>0.0840</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-56.44</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Karolinska Sleepiness Scale Day 4</title>
        <description>Self-reported fatigue measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The KSS is a single question asking the subject to rate how sleepy they feel at that moment on a 9-point scale where 1 = extremely awake and 9 = extremely sleepy/fighting to stay wake.</description>
        <time_frame>1 Day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tasimelteon</title>
            <description>tasimelteon, administered as oral capsule(s)&#xD;
Tasimelteon: capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, administered as oral capsule(s)&#xD;
Placebo: capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Karolinska Sleepiness Scale Day 4</title>
          <description>Self-reported fatigue measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The KSS is a single question asking the subject to rate how sleepy they feel at that moment on a 9-point scale where 1 = extremely awake and 9 = extremely sleepy/fighting to stay wake.</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.69" spread="0.388"/>
                    <measurement group_id="O2" value="-0.69" spread="0.409"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0765</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.00</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>15 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tasimelteon</title>
          <description>tasimelteon, administered as oral capsule(s)&#xD;
Tasimelteon: capsule</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo, administered as oral capsule(s)&#xD;
Placebo: capsule</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vanda Pharmaceuticals</name_or_title>
      <organization>Vanda Pharmaceuticals</organization>
      <phone>2027343400</phone>
      <email>clinicaltrials@vandapharma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03291041
org study id: VP-VEC-162-2102
nct id: NCT03291041
lead sponsor: 
has dmc: No
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With
      Jet Lag Disorder
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted
time frame: 4 days
description: Measured using polysomnography (PSG) and analyzed as change from baseline. Examination of the observational phase baseline data demonstrated that Night 3 was the night most disrupted.
measure: Patient Global Impression of Severity (PGI-S) Day 4
time frame: 1 Day
description: Self-reported global index measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The PGI-S is a single question asking the subject to rate their jet-lag condition at the present time on a scale of 1 "Normal" to 4 "Severe".
measure: Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights)
time frame: 3 Days
description: Measured using polysomnography (PSG) and analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight.
measure: Subjective Total Sleep Time on Night 3
time frame: 1 Day
description: Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
measure: Subjective Sleep Quality Night 3
time frame: 1 Day
description: Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline. Sleep quality was ranked from 1 "Poor" to 5 "Excellent" and was the subscale of the post-sleep questionnaire used to determine subjective sleep quality.
measure: Subjective Sleep Latency Night 3
time frame: 1 Day
description: Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
measure: Subjective Wake After Sleep Onset Night 3
time frame: 1 Day
description: Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
measure: Karolinska Sleepiness Scale Day 4
time frame: 1 Day
description: Self-reported fatigue measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The KSS is a single question asking the subject to rate how sleepy they feel at that moment on a 9-point scale where 1 = extremely awake and 9 = extremely sleepy/fighting to stay wake.
arm group label: tasimelteon
arm group type: Experimental
description: tasimelteon, administered as oral capsule(s)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, administered as oral capsule(s)
intervention type: Drug
intervention name: Tasimelteon
description: capsule
arm group label: tasimelteon
intervention type: Drug
intervention name: Placebo
description: capsule
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Jet Lag Syndrome
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 