<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/NCT03282591</url>
  </required_header>
  <id_info>
    <org_study_id>MTI-110</org_study_id>
    <secondary_id>2017-003250-16</secondary_id>
    <nct_id>NCT03282591</nct_id>
  </id_info>
  <brief_title>Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vyne Therapeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vyne Therapeutics Inc.</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>
      Study of the efficacy, safety, and tolerability of serlopitant for the treatment of&#xD;
      refractory chronic cough&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">September 6, 2018</completion_date>
  <primary_completion_date type="Actual">August 15, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)</measure>
    <time_frame>from Baseline to Day 84</time_frame>
    <description>Change in 24-hour objective cough frequency is total number of cough events during the monitoring period (24-hour interval)/24 (Total duration (in hours) for the monitoring period) which is captured through sound recordings by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Awake Objective Cough Frequency</measure>
    <time_frame>from Baseline to Day 84</time_frame>
    <description>Awake cough frequency = (total number of cough events during the monitoring period (24-hour interval) the subject is awake)/(Total duration (in hours) for the monitoring period the subject is awake) which is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency</measure>
    <time_frame>from Baseline to Day 84</time_frame>
    <description>The percentage of participants with ≥ 30% of reduction from baseline in 24-hour cough frequency is the number of participants with ≤-30% change in 24-hour cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency</measure>
    <time_frame>from Baseline to Day 84</time_frame>
    <description>The percentage of participants with ≥ 30% of reduction from baseline in the awake cough frequency is the number of participants with ≤30% change in awake cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Cough Severity Visual Analog Scale (VAS)</measure>
    <time_frame>from Baseline to Day 84</time_frame>
    <description>Visual Analog Scale (VAS) 101-point scale ranging from 0 (no cough) to 100 (worst cough). A higher score corresponds to higher cough severity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">185</enrollment>
  <condition>Refractory Chronic Cough</condition>
  <arm_group>
    <arm_group_label>5 mg Serlopitant Tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Serlopitant Tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matching Placebo Tablets</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5 mg Serlopitant Tablets</intervention_name>
    <description>Serlopitant Tablets</description>
    <arm_group_label>5 mg Serlopitant Tablets</arm_group_label>
    <other_name>VPD-737</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching Placebo Tablets</intervention_name>
    <description>Placebo Tablets</description>
    <arm_group_label>Matching Placebo Tablets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female and males between 18 and 80 years of age&#xD;
&#xD;
          -  Have a diagnosis of treatment refractory chronic cough or unexplained cough for at&#xD;
             least one year&#xD;
&#xD;
          -  Chest radiograph or computed tomography (CT) Thorax within the last 5 years not&#xD;
             demonstrating any abnormality considered to be significantly contributing to the&#xD;
             chronic cough&#xD;
&#xD;
          -  At Screening have a score of ≥ 40mm on the Cough Severity VAS&#xD;
&#xD;
          -  At Baseline (Day 0) have a score of ≥ 40mm on the Cough Severity VAS&#xD;
&#xD;
          -  All female subjects who are of childbearing potential must practice highly effective&#xD;
             contraception (i.e., pregnancy prevention method with a failure rate of &lt; 1% per year)&#xD;
             from the time of the initial screening visit until 4 weeks after last dose of study&#xD;
             drug. Please refer to the protocol for acceptable methods of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with serlopitant or other NK1-R antagonist&#xD;
&#xD;
          -  Presence of any medical condition or disability that could interfere with study&#xD;
&#xD;
          -  History of hypersensitivity to serlopitant or any of its components&#xD;
&#xD;
          -  Currently pregnant or male partner of pregnant female&#xD;
&#xD;
          -  Females of childbearing potential who are unable or unwilling to use adequate&#xD;
             contraception or who are breast feeding&#xD;
&#xD;
          -  Current smoker or individuals who have given up smoking within the past 12 months&#xD;
&#xD;
          -  FEV1/FVC &lt; 60%&#xD;
&#xD;
          -  Body mass index (BMI) &lt;18 kg/m2 or ≥ 40 kg/m2 at Screening&#xD;
&#xD;
          -  History of upper or lower respiratory tract infection or recent significant change in&#xD;
             pulmonary status within 4 weeks of the Baseline Visit (Day 0)&#xD;
&#xD;
          -  History of cystic fibrosis&#xD;
&#xD;
          -  History of opioid use within 1 week of the Baseline Visit (Day 0)&#xD;
&#xD;
          -  Requiring concomitant therapy with prohibited medications&#xD;
&#xD;
          -  Treatment with biologic therapies within 8 weeks or 5 half-lives prior to the Baseline&#xD;
             Visit (Day 0), whichever is longer&#xD;
&#xD;
          -  Treatment with strong CYP3A4 inhibitors within 4 weeks prior to the Baseline Visit&#xD;
             (Day 0)&#xD;
&#xD;
          -  Treatment with any investigational therapy within 4 weeks (investigational biologic&#xD;
             therapies within 8 weeks) prior to the Baseline Visit (Day 0)&#xD;
&#xD;
          -  Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate&#xD;
             aminotransferase (AST) &gt; 2x the upper limit of normal (ULN) during screening&#xD;
&#xD;
          -  Positive test for any drug of abuse&#xD;
&#xD;
          -  History of malignancy within 5 years prior to the Baseline Visit (Day 0), with the&#xD;
             exception of completely treated and non-metastatic basal cell carcinoma or squamous&#xD;
             cell carcinoma of the skin&#xD;
&#xD;
          -  Any known psychiatric diagnosis meeting DSM-5 criteria which may confound the&#xD;
             assessment of serlopitant safety or efficacy, or interfere with the subject's ability&#xD;
             to comply with protocol-mandated activities, within 3 years prior to randomization.&#xD;
             Examples of such DSM-5 diagnoses include but are not limited to major depressive&#xD;
             disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual&#xD;
             disability, severe alcohol use disorder.&#xD;
&#xD;
          -  Known active hepatitis infection&#xD;
&#xD;
          -  Known history of human immunodeficiency virus (HIV) infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacky Smith</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manchester, United Kingdom</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Study Site 130</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 128</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 123</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 127</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 131</name>
      <address>
        <city>Stockton</city>
        <state>California</state>
        <zip>95207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 106</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 113</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 108</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 118</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33778</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 107</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 115</name>
      <address>
        <city>Plymouth</city>
        <state>Minnesota</state>
        <zip>55441</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 110</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 121</name>
      <address>
        <city>Ocean Township</city>
        <state>New Jersey</state>
        <zip>07712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 125</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 129</name>
      <address>
        <city>Charleston</city>
        <state>North Carolina</state>
        <zip>29420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 103</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 111</name>
      <address>
        <city>Gastonia</city>
        <state>North Carolina</state>
        <zip>28054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 114</name>
      <address>
        <city>Mooresville</city>
        <state>North Carolina</state>
        <zip>28117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 122</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 112</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 117</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 116</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 104</name>
      <address>
        <city>Rock Hill</city>
        <state>South Carolina</state>
        <zip>29732</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 102</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 120</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 101</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 109</name>
      <address>
        <city>Waco</city>
        <state>Texas</state>
        <zip>76712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 126</name>
      <address>
        <city>Bellingham</city>
        <state>Washington</state>
        <zip>98225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 105</name>
      <address>
        <city>Greenfield</city>
        <state>Wisconsin</state>
        <zip>53228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 133</name>
      <address>
        <city>Belfast</city>
        <zip>BT9 7AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 139</name>
      <address>
        <city>Birmingham</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 136</name>
      <address>
        <city>Cottingham</city>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 141</name>
      <address>
        <city>Llanelli</city>
        <zip>SA14 8QF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 138</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 137</name>
      <address>
        <city>London</city>
        <zip>SW3 6HP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 132</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 135</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 134</name>
      <address>
        <city>Preston</city>
        <zip>PR2 9HT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 140</name>
      <address>
        <city>Taunton</city>
        <zip>TA2 5DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <results_first_submitted>July 29, 2019</results_first_submitted>
  <results_first_submitted_qc>October 21, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 22, 2019</results_first_posted>
  <last_update_submitted>May 18, 2021</last_update_submitted>
  <last_update_submitted_qc>May 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 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>Cough</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Serlopitant</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03282591/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03282591/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Serlopitant 5 mg</title>
          <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Subjects received a 3-tablet Placebo loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>These figures represent the Full Analysis set (FAS) and is defined as all randomized subjects who received any amount of study treatment and had Baseline and at least one post baseline observation of the primary endpoint during the treatment period.</population>
      <group_list>
        <group group_id="B1">
          <title>Serlopitant 5 mg</title>
          <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</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="88"/>
            <count group_id="B2" value="88"/>
            <count group_id="B3" value="176"/>
          </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="62.7" spread="11.21"/>
                    <measurement group_id="B2" value="62.6" spread="10.09"/>
                    <measurement group_id="B3" value="62.6" spread="10.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.5" lower_limit="28" upper_limit="79"/>
                    <measurement group_id="B2" value="64.5" lower_limit="26" upper_limit="80"/>
                    <measurement group_id="B3" value="65" lower_limit="26" upper_limit="80"/>
                  </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="68"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="135"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </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="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="170"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">This criterion was not collected.</measurement>
                    <measurement group_id="B2" value="NA">This criterion was not collected.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_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="69"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)</title>
        <description>Change in 24-hour objective cough frequency is total number of cough events during the monitoring period (24-hour interval)/24 (Total duration (in hours) for the monitoring period) which is captured through sound recordings by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).</description>
        <time_frame>from Baseline to Day 84</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Serlopitant 5 mg</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)</title>
          <description>Change in 24-hour objective cough frequency is total number of cough events during the monitoring period (24-hour interval)/24 (Total duration (in hours) for the monitoring period) which is captured through sound recordings by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).</description>
          <units>coughs/hr</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="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="0.09"/>
                    <measurement group_id="O2" value="-0.45" spread="0.08"/>
                  </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>0.9942</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>31.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>56.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Awake Objective Cough Frequency</title>
        <description>Awake cough frequency = (total number of cough events during the monitoring period (24-hour interval) the subject is awake)/(Total duration (in hours) for the monitoring period the subject is awake) which is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).</description>
        <time_frame>from Baseline to Day 84</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Serlopitant 5 mg</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects received a 3-tablet Placebo loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Awake Objective Cough Frequency</title>
          <description>Awake cough frequency = (total number of cough events during the monitoring period (24-hour interval) the subject is awake)/(Total duration (in hours) for the monitoring period the subject is awake) which is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).</description>
          <units>coughs/hr</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 28 (Week 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" lower_limit="-0.26" upper_limit="0.01"/>
                    <measurement group_id="O2" value="-0.30" lower_limit="-0.43" upper_limit="-0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56 (Week 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.25" lower_limit="-0.39" upper_limit="-0.10"/>
                    <measurement group_id="O2" value="-0.32" lower_limit="-0.47" upper_limit="-0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84 (Week 12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.19" lower_limit="-0.34" upper_limit="-0.04"/>
                    <measurement group_id="O2" value="-0.46" lower_limit="-0.60" upper_limit="-0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency</title>
        <description>The percentage of participants with ≥ 30% of reduction from baseline in 24-hour cough frequency is the number of participants with ≤-30% change in 24-hour cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).</description>
        <time_frame>from Baseline to Day 84</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Serlopitant 5 mg</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects received a 3-tablet Placebo loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency</title>
          <description>The percentage of participants with ≥ 30% of reduction from baseline in 24-hour cough frequency is the number of participants with ≤-30% change in 24-hour cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).</description>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.4"/>
                    <measurement group_id="O2" value="90.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency</title>
        <description>The percentage of participants with ≥ 30% of reduction from baseline in the awake cough frequency is the number of participants with ≤30% change in awake cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).</description>
        <time_frame>from Baseline to Day 84</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Serlopitant 5 mg</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects received a 3-tablet Placebo loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency</title>
          <description>The percentage of participants with ≥ 30% of reduction from baseline in the awake cough frequency is the number of participants with ≤30% change in awake cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.6"/>
                    <measurement group_id="O2" value="37.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Cough Severity Visual Analog Scale (VAS)</title>
        <description>Visual Analog Scale (VAS) 101-point scale ranging from 0 (no cough) to 100 (worst cough). A higher score corresponds to higher cough severity.</description>
        <time_frame>from Baseline to Day 84</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Serlopitant 5 mg</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects received a 3-tablet Placebo loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Cough Severity Visual Analog Scale (VAS)</title>
          <description>Visual Analog Scale (VAS) 101-point scale ranging from 0 (no cough) to 100 (worst cough). A higher score corresponds to higher cough severity.</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 28 (Week 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.2" lower_limit="-14.6" upper_limit="-5.8"/>
                    <measurement group_id="O2" value="-9.9" lower_limit="-14.4" upper_limit="-5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56 (Week 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.6" lower_limit="-19.4" upper_limit="-9.8"/>
                    <measurement group_id="O2" value="-7.4" lower_limit="-12.3" upper_limit="-2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84 (Week 12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.2" lower_limit="-19.2" upper_limit="-9.3"/>
                    <measurement group_id="O2" value="-9.9" lower_limit="-15.0" upper_limit="-4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.</time_frame>
      <desc>The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Serlopitant 5 mg</title>
          <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Post procedural infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastatic malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</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="43" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Viral Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </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 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>Anna Gururajan</name_or_title>
      <organization>Menlo Therapeutics Inc.</organization>
      <phone>(650) 486-1416</phone>
      <email>agururajan@menlotx.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/NCT03282591
org study id: MTI-110
secondary id: 2017-003250-16
nct id: NCT03282591
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Study of the efficacy, safety, and tolerability of serlopitant for the treatment of
      refractory chronic cough
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)
time frame: from Baseline to Day 84
description: Change in 24-hour objective cough frequency is total number of cough events during the monitoring period (24-hour interval)/24 (Total duration (in hours) for the monitoring period) which is captured through sound recordings by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
measure: Change in Awake Objective Cough Frequency
time frame: from Baseline to Day 84
description: Awake cough frequency = (total number of cough events during the monitoring period (24-hour interval) the subject is awake)/(Total duration (in hours) for the monitoring period the subject is awake) which is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
measure: Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency
time frame: from Baseline to Day 84
description: The percentage of participants with ≥ 30% of reduction from baseline in 24-hour cough frequency is the number of participants with ≤-30% change in 24-hour cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
measure: Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency
time frame: from Baseline to Day 84
description: The percentage of participants with ≥ 30% of reduction from baseline in the awake cough frequency is the number of participants with ≤30% change in awake cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
measure: Change From Baseline in Cough Severity Visual Analog Scale (VAS)
time frame: from Baseline to Day 84
description: Visual Analog Scale (VAS) 101-point scale ranging from 0 (no cough) to 100 (worst cough). A higher score corresponds to higher cough severity.
arm group label: 5 mg Serlopitant Tablets
arm group type: Experimental
description: Serlopitant Tablets
arm group label: Matching Placebo Tablets
arm group type: Placebo Comparator
description: Placebo Tablets
intervention type: Drug
intervention name: 5 mg Serlopitant Tablets
description: Serlopitant Tablets
arm group label: 5 mg Serlopitant Tablets
other name: VPD-737
intervention type: Drug
intervention name: Matching Placebo Tablets
description: Placebo Tablets
arm group label: Matching Placebo Tablets
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jacky Smith
role: Principal Investigator
affiliation: University of Manchester, United Kingdom
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country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Cough
mesh term: Serlopitant
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