<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/NCT03772340</url>
  </required_header>
  <id_info>
    <org_study_id>VP-VLY-686-2401</org_study_id>
    <nct_id>NCT03772340</nct_id>
  </id_info>
  <brief_title>Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness</brief_title>
  <official_title>Motion Sifnos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the&#xD;
      treatment of motion sickness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">June 27, 2019</completion_date>
  <primary_completion_date type="Actual">June 6, 2019</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>Reduction in the incidence of vomiting</measure>
    <time_frame>1 Day</time_frame>
    <description>As measured by the Motion Sickness Severity Scale Motion Sickness Severity Scale (NRS 0-6); Lower score indicates improvement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in the cardinal symptoms of motion sickness</measure>
    <time_frame>1 Day</time_frame>
    <description>As measured by the Motion Sickness Severity Scale Motion Sickness Severity Scale (NRS 0-6); Lower score indicates improvement</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Motion Sickness</condition>
  <arm_group>
    <arm_group_label>Tradipitant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tradipitant</intervention_name>
    <description>Oral capsule</description>
    <arm_group_label>Tradipitant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral capsule</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive);&#xD;
&#xD;
          -  Body Mass Index (BMI) of ≥18 and ≤30 kg/m2;&#xD;
&#xD;
          -  History or symptoms consistent with motion sickness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic nausea due to condition other than motion sickness;&#xD;
&#xD;
          -  A positive test for drugs of abuse at the screening or evaluation visits;&#xD;
&#xD;
          -  Clinically significant deviation from normal clinical laboratory results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2020</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>Motion Sickness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03772340
org study id: VP-VLY-686-2401
nct id: NCT03772340
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the
      treatment of motion sickness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Reduction in the incidence of vomiting
time frame: 1 Day
description: As measured by the Motion Sickness Severity Scale Motion Sickness Severity Scale (NRS 0-6); Lower score indicates improvement
measure: Improvement in the cardinal symptoms of motion sickness
time frame: 1 Day
description: As measured by the Motion Sickness Severity Scale Motion Sickness Severity Scale (NRS 0-6); Lower score indicates improvement
arm group label: Tradipitant
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Tradipitant
description: Oral capsule
arm group label: Tradipitant
intervention type: Drug
intervention name: Placebo
description: Oral capsule
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Motion Sickness
sharing ipd: No