<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/NCT02996084</url>
  </required_header>
  <id_info>
    <org_study_id>888MS005</org_study_id>
    <nct_id>NCT02996084</nct_id>
  </id_info>
  <brief_title>MS PATHS Normative Sub-Study</brief_title>
  <official_title>Longitudinal Brain Volume Change (and Correlates) in Healthy Control Subjects: A Normative Sub-Study of Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biogen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biogen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to determine the normative range of brain volume and&#xD;
      brain volume change in healthy control (HC) participants whose age, race, and gender&#xD;
      distribution is approximately matched to the age, race, and gender distribution of patients&#xD;
      with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use&#xD;
      the results of the primary endpoint to ensure consistency of brain volume measurements across&#xD;
      MS PATHS centers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2017</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>Brain volume</measure>
    <time_frame>Every 12 months up to 3 years</time_frame>
    <description>Measured by using magnetic resonance imaging (MRI) scans</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain volume change</measure>
    <time_frame>Every 12 months up to 3 years</time_frame>
    <description>Measured by using MRI scans</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Development of models to calibrate brain volume measurements between centers, if necessary</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Measured by using MRI scans</description>
  </secondary_outcome>
  <enrollment type="Actual">246</enrollment>
  <condition>Healthy Volunteer</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Ribonucleic acid (RNA), serum, and whole blood biomarker samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy control (HC) participants enrolled at each institution will be carefully selected&#xD;
        to result in a group whose age, race, and gender distribution is approximately matched to&#xD;
        the age, race, and gender distribution of patients with MS enrolled in MS PATHS at that&#xD;
        center. Patients enrolled in MS PATHS at each center will be encouraged to enlist a friend&#xD;
        or family member to participate in the study as an HC. Subsequently, on approximately&#xD;
        quarterly review of participant participation, particular demographic groups will be&#xD;
        targeted for recruitment, if needed, in order for the age, race, and gender distribution of&#xD;
        a center's HC sample to be similar to their MS PATHS participant sample (within the study&#xD;
        age range).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Key Inclusion Criteria&#xD;
&#xD;
          -  Ability to understand the purpose and risks of the study and provide signed and dated&#xD;
             informed consent and authorization to use protected health information in accordance&#xD;
             with national and local participant privacy regulations.&#xD;
&#xD;
        Key Exclusion Criteria&#xD;
&#xD;
          -  History of human immunodeficiency virus.&#xD;
&#xD;
          -  Confirmed or suspected pregnancy.&#xD;
&#xD;
          -  Diagnosis of migraine requiring medication or any other participant-reported diagnosis&#xD;
             of a neurological disease or condition (e.g., stroke, transient ischemic attack,&#xD;
             epilepsy, brain infection, brain surgery, prior head injury or concussion, or brain&#xD;
             tumor).&#xD;
&#xD;
          -  Any participant-reported diagnosis of an autoimmune disorder (e.g., rheumatoid&#xD;
             arthritis, Sjögren's syndrome, scleroderma, or systemic lupus erythematosus).&#xD;
&#xD;
          -  Standard MRI exclusion criteria, including claustrophobia, inability to lay still in&#xD;
             the magnet (e.g., tremor), or any type of implanted metal in the body that would be&#xD;
             affected by the strong magnetic field.&#xD;
&#xD;
        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Biogen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Carl Gustav Carus Dresden</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiple Sclerosis Centre of Catalonia (Cemcat) Vall d'Hebron Hospital</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>February 23, 2023</last_update_submitted>
  <last_update_submitted_qc>February 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Imaging research</keyword>
  <!-- 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/NCT02996084
org study id: 888MS005
nct id: NCT02996084
lead sponsor: 
has dmc: No
The primary objective of this study is to determine the normative range of brain volume and
      brain volume change in healthy control (HC) participants whose age, race, and gender
      distribution is approximately matched to the age, race, and gender distribution of patients
      with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use
      the results of the primary endpoint to ensure consistency of brain volume measurements across
      MS PATHS centers.
observational model: Cohort
time perspective: Prospective
measure: Brain volume
time frame: Every 12 months up to 3 years
description: Measured by using magnetic resonance imaging (MRI) scans
measure: Brain volume change
time frame: Every 12 months up to 3 years
description: Measured by using MRI scans
measure: Development of models to calibrate brain volume measurements between centers, if necessary
time frame: Up to 3 years
description: Measured by using MRI scans
Ribonucleic acid (RNA), serum, and whole blood biomarker samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Biogen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Spain
country: United States
responsible party type: Sponsor