xml: <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/NCT06019338</url>
    </required_header>
    <id_info>
      <org_study_id>NOE-PRO-001</org_study_id>
      <nct_id>NCT06019338</nct_id>
    </id_info>
    <brief_title>A Study to Validate a Pain Diary for Patient With Trigeminal Neuralgia</brief_title>
    <official_title>A Study to Validate a Diary Developed by Noema Pharma That Will be Used for Future Trigeminal Neuralgia Clinical Research Studies to Capture Pain Dimensions.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Noema Pharma AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Noema Pharma AG</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study is to establish the validity of a patient reported diary in TN . The&#xD;
        following objectives have been identified:&#xD;
  &#xD;
          1. To generate evidence to support diary content validity by performing qualitative&#xD;
             research studies with TN patients and Healthcare Professionals (HCPs).&#xD;
  &#xD;
          2. To provide further support to the diary, sensitivity to change, known groups validity&#xD;
             (ability to differentiate between severity groups), and construct validity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will engage up to 20 participants with TN through patient associations or HCPs.&#xD;
        The study will be conducted in English Speaking countries.&#xD;
  &#xD;
        The study comprises the following parts :&#xD;
  &#xD;
          -  Participants Recruitment&#xD;
  &#xD;
          -  Completion of the Diary&#xD;
  &#xD;
          -  Qualitative interviews with participants&#xD;
  &#xD;
          -  Analysis of qualitative research to assess content validity&#xD;
  &#xD;
          -  Secondary analysis as a workshop with a panel of experts to finalize the diary The diary&#xD;
             will be provided to each participant and to HCPs. Participants will be requested to&#xD;
             follow the instructions, use the diary and provide their feedback on the diary.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">November 20, 2021</start_date>
    <completion_date type="Anticipated">August 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Measure of pain associated with Trigeminal Neuralgia</measure>
      <time_frame>2 weeks</time_frame>
      <description>Use of the TN Pain questionnaire to measure the pain associated with trigeminal neuralgia</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Concept elicitation of the diary content</measure>
      <time_frame>1 day</time_frame>
      <description>During an interview, assess if the questionnaire is comprehensive, clear and correctly captures patients experience</description>
    </primary_outcome>
    <enrollment type="Actual">30</enrollment>
    <condition>Trigeminal Neuralgia</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pain Diary use</intervention_name>
      <description>Validation of a pain diary specifically designed to capture pain dimensions of Trigeminal Neuralgia</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients or former patients with diagnosed trigeminal neuralgia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or Female aged of 40 years or more.&#xD;
  &#xD;
            -  Must be able to read, write, and speak English to complete the consent process and&#xD;
               participate in an interview.&#xD;
  &#xD;
            -  Able and willing to provide consent for participation in the study, and to allow the&#xD;
               study team to access their data entries including audio or video recordings. - -&#xD;
               Participant with a current or previous diagnosis of TN&#xD;
  &#xD;
            -  Willing to participate in up to 30 minutes remote interviews or in-person interview&#xD;
               (this interview will be recorded by the HCP)&#xD;
  &#xD;
            -  Committ to fill in the diary according to the HCP instruction&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not applicable&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Kainzen Centre</name>
        <address>
          <city>La Jolla</city>
          <state>California</state>
          <zip>92037</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>ULC Research</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 1, 2022</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</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>Trigeminal Neuralgia</mesh_term>
      <mesh_term>Neuralgia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019338
  org study id: NOE-PRO-001
  nct id: NCT06019338
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to establish the validity of a patient reported diary in TN . The
        following objectives have been identified:
  
          1. To generate evidence to support diary content validity by performing qualitative
             research studies with TN patients and Healthcare Professionals (HCPs).
  
          2. To provide further support to the diary, sensitivity to change, known groups validity
             (ability to differentiate between severity groups), and construct validity.
  This study will engage up to 20 participants with TN through patient associations or HCPs.
        The study will be conducted in English Speaking countries.
  
        The study comprises the following parts :
  
          -  Participants Recruitment
  
          -  Completion of the Diary
  
          -  Qualitative interviews with participants
  
          -  Analysis of qualitative research to assess content validity
  
          -  Secondary analysis as a workshop with a panel of experts to finalize the diary The diary
             will be provided to each participant and to HCPs. Participants will be requested to
             follow the instructions, use the diary and provide their feedback on the diary.
  observational model: Cohort
  time perspective: Prospective
  measure: Measure of pain associated with Trigeminal Neuralgia
  time frame: 2 weeks
  description: Use of the TN Pain questionnaire to measure the pain associated with trigeminal neuralgia
  measure: Concept elicitation of the diary content
  time frame: 1 day
  description: During an interview, assess if the questionnaire is comprehensive, clear and correctly captures patients experience
  intervention type: Other
  intervention name: Pain Diary use
  description: Validation of a pain diary specifically designed to capture pain dimensions of Trigeminal Neuralgia
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  facility: 
  facility: 
  country: United Kingdom
  country: United States
  responsible party type: Sponsor
  mesh term: Trigeminal Neuralgia
  mesh term: Neuralgia
  sharing ipd: No