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/NCT05988073</url>
    </required_header>
    <id_info>
      <org_study_id>ARGX-117-2202</org_study_id>
      <nct_id>NCT05988073</nct_id>
    </id_info>
    <brief_title>A Prospective Longitudinal Study in Adults With Multifocal Motor Neuropathy</brief_title>
    <official_title>A Multicenter Prospective Longitudinal Study of Clinical Outcomes, Disease Course, Health-Related Quality of Life, and Health Care Resource Utilization in Adult Patients With Multifocal Motor Neuropathy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>argenx</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>argenx</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This prospective longitudinal study will follow participants with Multifocal Motor Neuropathy&#xD;
        over time and collect data on their clinical outcomes, quality of life, and use of health&#xD;
        care resources. Participants will follow their regular visit schedule with their treating&#xD;
        physician, except for an optional second visit occurring 7 to 14 days after the start of the&#xD;
        study to collect biomarker data. No IMP will be administered.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">November 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2025</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>To characterize MMN patient profiles for participants</measure>
      <time_frame>up to 24 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>To assess the MMN disease management and disease course</measure>
      <time_frame>up to 24 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>To assess outcome measures specific to MMN disease and their evolution over time</measure>
      <time_frame>up to 24 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>To estimate the burden of MMN on participants' quality of life</measure>
      <time_frame>up to 24 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>To estimate the economic burden for participants with MMN</measure>
      <time_frame>up to 24 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>To collect data on relevant disease biomarkers</measure>
      <time_frame>up to 24 months</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Multifocal Motor Neuropathy</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with MMN receiving standard of care at their treating physician.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Is at least the local legal age of consent for clinical studies when signing the ICF&#xD;
  &#xD;
            -  Is capable of providing signed informed consent and complying with protocol&#xD;
               requirements&#xD;
  &#xD;
            -  Has an existing or new diagnosis of MMN made by a neuromuscular specialist or&#xD;
               neurologist&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Is currently participating in any clinical study with an IMP&#xD;
  &#xD;
            -  Has other medical conditions that could affect the assessment of MMN&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sabine Coppieters, MD</last_name>
      <phone>857-350-4834</phone>
      <email>ClinicalTrials@argenx.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 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>Neuritis</mesh_term>
    </condition_browse>
    <!-- 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/NCT05988073
  org study id: ARGX-117-2202
  nct id: NCT05988073
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This prospective longitudinal study will follow participants with Multifocal Motor Neuropathy
        over time and collect data on their clinical outcomes, quality of life, and use of health
        care resources. Participants will follow their regular visit schedule with their treating
        physician, except for an optional second visit occurring 7 to 14 days after the start of the
        study to collect biomarker data. No IMP will be administered.
  observational model: Cohort
  time perspective: Prospective
  measure: To characterize MMN patient profiles for participants
  time frame: up to 24 months
  measure: To assess the MMN disease management and disease course
  time frame: up to 24 months
  measure: To assess outcome measures specific to MMN disease and their evolution over time
  time frame: up to 24 months
  measure: To estimate the burden of MMN on participants' quality of life
  time frame: up to 24 months
  measure: To estimate the economic burden for participants with MMN
  time frame: up to 24 months
  measure: To collect data on relevant disease biomarkers
  time frame: up to 24 months
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sabine Coppieters, MD
  phone: 857-350-4834
  email: ClinicalTrials@argenx.com
  responsible party type: Sponsor
  mesh term: Neuritis