<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/NCT04474990</url>
  </required_header>
  <id_info>
    <org_study_id>VP-VLY-686-3303</org_study_id>
    <nct_id>NCT04474990</nct_id>
  </id_info>
  <brief_title>SINGLE-PATIENT EXPANDED ACCESS PROTOCOL FOR TRADIPITANT IN A SINGLE PATIENT WITH GASTROPARESIS</brief_title>
  <official_title>VP-VLY-686-3303: SINGLE-PATIENT EXPANDED ACCESS PROTOCOL FOR TRADIPITANT IN A SINGLE PATIENT WITH GASTROPARESIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanda Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanda Pharmaceuticals</source>
  <brief_summary>
    <textblock>
      Primary Objective: To treat a single patient with gastroparesis who has requested expanded&#xD;
      access with tradipitant&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-patient extended access treatment protocol to be conducted in the United&#xD;
      States. Investigator-Physician has determined patient satisfies expanded access inclusion&#xD;
      criteria and has requested expanded access to tradipitant.&#xD;
&#xD;
      Patient will be given open label tradipitant 85 mg to be taken twice daily at 12 hour&#xD;
      intervals for long term treatment. Patient can fill out daily web-based symptom diaries on a&#xD;
      voluntary basis and report any adverse events to Investigator-Physician.&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      -To treat a single patient with gastroparesis who has requested expanded access with&#xD;
      tradipitant&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To monitor the efficacy of tradipitant in reducing individual symptoms associated with&#xD;
           gastroparesis in this single patient&#xD;
&#xD;
        -  To monitor the safety of tradipitant in a patient with gastroparesis by assessing&#xD;
           adverse events in this single patient&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Available</overall_status>
  <study_type>Expanded Access</study_type>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
  </expanded_access_info>
  <condition>Gastroparesis</condition>
  <condition>Diabetic Gastroparesis</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tradipitant</intervention_name>
    <description>NK-1 Receptor antagonist</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Identified subject who requested expanded access&#xD;
&#xD;
          -  Diagnosed with gastroparesis&#xD;
&#xD;
          -  Demonstrated delayed gastric emptying&#xD;
&#xD;
          -  Presence of moderate to severe nausea&#xD;
&#xD;
          -  Patient does not qualify for or does not have access to other clinical trials with&#xD;
             tradipitant;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Another active disorder or treatment which could explain or contribute to symptoms of&#xD;
             gastroparesis&#xD;
&#xD;
          -  A positive test for drugs of abuse at the screening or evaluation visits;&#xD;
&#xD;
          -  Exposure to any investigational medication in the past 60 days other than tradipitant&#xD;
&#xD;
          -  Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric&#xD;
             stimulation device surgically implanted within the last year&#xD;
&#xD;
          -  Any other reason as determined by the Investigator which may lead to an unfavorable&#xD;
             risk-benefit ratio to treatment;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Vanda Pharmaceuticals</last_name>
    <phone>2027343400</phone>
    <email>clinicaltrials@vandapharma.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75024</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Available</status>
    <contact>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gastroparesis</keyword>
  <keyword>idiopathic</keyword>
  <keyword>diabetic</keyword>
  <keyword>tradipitant</keyword>
  <keyword>nausea</keyword>
  <keyword>vomiting</keyword>
  <keyword>stomach</keyword>
  <keyword>motility</keyword>
  <keyword>functional</keyword>
  <keyword>NK-1 antagonist</keyword>
  <keyword>neurokinin 1 receptor</keyword>
  <keyword>substance p</keyword>
  <keyword>expanded access</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04474990
org study id: VP-VLY-686-3303
nct id: NCT04474990
lead sponsor: 
Primary Objective: To treat a single patient with gastroparesis who has requested expanded
      access with tradipitant
This is a single-patient extended access treatment protocol to be conducted in the United
      States. Investigator-Physician has determined patient satisfies expanded access inclusion
      criteria and has requested expanded access to tradipitant.

      Patient will be given open label tradipitant 85 mg to be taken twice daily at 12 hour
      intervals for long term treatment. Patient can fill out daily web-based symptom diaries on a
      voluntary basis and report any adverse events to Investigator-Physician.

      Primary Objective:

      -To treat a single patient with gastroparesis who has requested expanded access with
      tradipitant

      Secondary Objectives:

        -  To monitor the efficacy of tradipitant in reducing individual symptoms associated with
           gastroparesis in this single patient

        -  To monitor the safety of tradipitant in a patient with gastroparesis by assessing
           adverse events in this single patient
expanded access type individual: Yes
intervention type: Drug
intervention name: Tradipitant
description: NK-1 Receptor antagonist
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
last name: Vanda Pharmaceuticals
phone: 2027343400
email: clinicaltrials@vandapharma.com
facility: 
status: Available
contact: 
country: United States
responsible party type: Sponsor
mesh term: Gastroparesis