<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/NCT04458051</url>
  </required_header>
  <id_info>
    <org_study_id>EFC16035</org_study_id>
    <secondary_id>U1111-1238-1318</secondary_id>
    <nct_id>NCT04458051</nct_id>
  </id_info>
  <brief_title>Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)</brief_title>
  <acronym>PERSEUS</acronym>
  <official_title>A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Primary Objective:&#xD;
&#xD;
      To determine the efficacy of SAR442168 compared to placebo in delaying disability progression&#xD;
      in primary progressive multiple sclerosis (PPMS)&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic&#xD;
      resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of&#xD;
      life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics&#xD;
      (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate&#xD;
      pharmacodynamics of SAR442168&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study duration will vary per participant in this event driven trial with a treatment duration&#xD;
      of approximately 24 to 48 months.&#xD;
&#xD;
      Participants completing the treatment period will be proposed to enroll in a separate long&#xD;
      term safety study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6 month Confirmed Disability Progression (CDP)</measure>
    <time_frame>Up to approximately 48 months</time_frame>
    <description>Time to onset of 6 month CDP defined as follows:&#xD;
Increase of ≥1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is ≤5.5, or Increase of ≥0.5 points when the baseline EDSS score is &gt;5.5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>3-month confirmed disability progression (CDP)</measure>
    <time_frame>Up to approximately 48 months</time_frame>
    <description>Time to onset of 3-month CDP as assessed by EDSS score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-month change in 9-hole peg test (9-HPT)</measure>
    <time_frame>Up to approximately 48 months</time_frame>
    <description>Time to onset of sustained 20% increase in the 9-HPT test confirmed over at least 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-month change in timed 25 foot walk (T25-FW)</measure>
    <time_frame>Up to approximately 48 months</time_frame>
    <description>Time to onset of sustained 20% increase in the T25-FW confirmed over at least 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in T2 hyperintense lesions by MRI</measure>
    <time_frame>From Baseline up to 48 approximately months</time_frame>
    <description>Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI after baseline up to and including the end of study (EOS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to onset of confirmed disability improvement (CDI)</measure>
    <time_frame>From Baseline up to 48 approximately months</time_frame>
    <description>Time to onset of CDI defined as ≥1.0 point decrease on the EDSS score from baseline confirmed over at least 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in Brain volume loss (BVL)</measure>
    <time_frame>From 6 months up to approximately 48 months -</time_frame>
    <description>Percent change in brain volume loss (BVL) as detected by brain MRI at the EOS compared to month 6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive function as assessed by the Symbol Digit Modalities Test (SDMT)</measure>
    <time_frame>From Baseline up to approximately 48 months</time_frame>
    <description>Change in cognitive function at the EOS compared to baseline as assessed by the SDMT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive function as assessed by the California Verbal Learning Test II (CVLT-II)</measure>
    <time_frame>From Baseline up to approximately 48 months</time_frame>
    <description>Change in cognitive function at the EOS compared to baseline as assessed by the CVLT-II</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Multiple Sclerosis Quality of Life</measure>
    <time_frame>From Baseline up to approximately 48 months</time_frame>
    <description>Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) at the EOS compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability</measure>
    <time_frame>From screening up to approximately 48 months</time_frame>
    <description>Number of participants with adverse events (AEs), Serious AEs, AEs leading to permanent study intervention discontinuation, and adverse events of special interest (AESI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population pharmacokinetics</measure>
    <time_frame>Months 6, 9 and 12</time_frame>
    <description>Plasma concentration of SAR442168 (population PK assessment) at Months 6, 9, and 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma neurofilament light chain (NfL)</measure>
    <time_frame>From Baseline up to approximately 48 months</time_frame>
    <description>Change in NfL levels from at the EOS compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lymphocyte phenotype subsets</measure>
    <time_frame>From Baseline up to approximately 48 months</time_frame>
    <description>Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline in a subset of participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum Immunoglobulin level</measure>
    <time_frame>From Baseline up to approximately 48 months</time_frame>
    <description>Changes in serum Immunoglobulin level at the EOS compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum chitinase-3 like protein 1 (Chi3L1)</measure>
    <time_frame>From Baseline up to approximately 48 months -</time_frame>
    <description>Change in serum chitinase-3 like protein 1 (Chi3L1) from baseline to EOS</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">990</enrollment>
  <condition>Primary Progressive Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>SAR442168</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose 1 of oral SAR442168 daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo to match the SAR442168 daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tolebrutinib</intervention_name>
    <description>Pharmaceutical form: Film-coated Tablet Route of administration: Oral</description>
    <arm_group_label>SAR442168</arm_group_label>
    <other_name>SAR442168</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Pharmaceutical form: Film-coated Tablet Route of administration: Oral</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  18 to 55 years of age inclusive&#xD;
&#xD;
          -  Diagnosis of PPMS according to the 2017 McDonald criteria&#xD;
&#xD;
          -  Expanded disability status scale (EDSS) between 2.0 to 6.5 points, inclusive at&#xD;
             screening&#xD;
&#xD;
          -  Disease duration from the onset of MS symptoms of &lt;15 years if screening EDSS score of&#xD;
             &gt;5.0 OR &lt;10 years if screening EDSS score of ≤5.0.&#xD;
&#xD;
          -  Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG)&#xD;
             index either during screening or documented previous history.&#xD;
&#xD;
          -  Contraceptive use consistent with local regulations for individuals participating in&#xD;
             clinical studies&#xD;
&#xD;
          -  Participant is eligible to participate if she is not pregnant or breastfeeding, and at&#xD;
             least one of the following conditions applies:&#xD;
&#xD;
               -  Is not a woman of child bearing potential (WOCBP) OR&#xD;
&#xD;
               -  Is a WOCBP and agrees to use an acceptable contraceptive method&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Participant has conditions that would adversely affect study participation such as&#xD;
             short life expectancy.&#xD;
&#xD;
          -  Evidence of infection with human immunodeficiency virus (HIV), transplantation,&#xD;
             progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or&#xD;
             latent tuberculosis or other active infection that would adversely affect study&#xD;
             participation.&#xD;
&#xD;
          -  Persistent chronic or active or recurring system infection that may adversely affect&#xD;
             participation or IMP administration in this study as judged by the investigator&#xD;
&#xD;
          -  History of malignancy within 5 years prior to screening.&#xD;
&#xD;
          -  History of alcohol or drug abuse within 1 year prior to Screening.&#xD;
&#xD;
          -  Hospitalized for psychiatric disease within 2 years prior to Screening.&#xD;
&#xD;
          -  Clinically significant laboratory abnormalities (including evidence of liver injury)&#xD;
             or electrocardiogram abnormalities at Screening.&#xD;
&#xD;
          -  Bleeding disorder, known platelet dysfunction at any time prior to the screening visit&#xD;
&#xD;
          -  A platelet count &lt;150 000/μL at the screening visit.&#xD;
&#xD;
          -  A history of significant bleeding event within 6 months prior to screening, according&#xD;
             to the Investigator's judgment such as, but not limited to cerebral or&#xD;
             gastrointestinal&#xD;
&#xD;
          -  Lymphocyte count below the lower limit of normal at Screening.&#xD;
&#xD;
          -  Recent live (attenuated) vaccine within 2 months before the first treatment visit.&#xD;
&#xD;
          -  Recent major surgery (within 4 weeks of Screening) or planned major surgery during the&#xD;
             study.&#xD;
&#xD;
          -  The participant has received medications/treatments for MS within a specified time&#xD;
             frame.&#xD;
&#xD;
          -  Receiving potent and moderate inducers or inhibitors of cytochrome P450 3A (CYP3A) or&#xD;
             potent inhibitors of CYP2C8 hepatic enzymes.&#xD;
&#xD;
          -  Receiving anticoagulant or antiplatelet therapy (such as aspirin&gt;81mg/day,&#xD;
             clopidogrel, warfarin).&#xD;
&#xD;
          -  Contraindications to magnetic resonance imaging (MRI).&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Trial Transparency email recommended (Toll free number for US &amp; Canada)</last_name>
    <phone>800-633-1610</phone>
    <phone_ext>option 6</phone_ext>
    <email>Contact-US@sanofi.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Arcadia Neurology Center-Site Number:8400070</name>
      <address>
        <city>Arcadia</city>
        <state>California</state>
        <zip>91006</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>UC San Diego ACTRI-Site Number:8400101</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Collaborative Neuroscience Research-Site Number:8400045</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Multiple Sclerosis Center of California-Site Number:8400135</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of San Francisco, Sandler Neurosciences Center-Site Number:8400137</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Harbor UCLA-Site Number:8400088</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Colorado-Site Number:8400012</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80262</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Advanced Neurosciences Research-Site Number:8400025</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80528</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>South Florida Neurology Associates-Site Number:8400029</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33487</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Florida, Fixel Center for Neurology-Site Number:8400159</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurology Associates, PA-Site Number:8400004</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32761</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of South Florida-Site Number:8400006</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research-Site Number:8400003</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hawaii Pacific Neuroscience-Site Number:8400103</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Consultants In Neurology-Site Number:8400011</name>
      <address>
        <city>Northbrook</city>
        <state>Illinois</state>
        <zip>60062</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Prairie Education and Research Cooperative-Site Number:8400071</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Methodist Hospital-Site Number:8400164</name>
      <address>
        <city>Merrillville</city>
        <state>Indiana</state>
        <zip>46410</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>College Park Family Care Certer-Site Number:8400044</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Kentucky-Site Number:8400106</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ochsner Baptist Clinical Trials Unit (CTU)-Site Number:8400107</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>International Neurorehabilitation Institute-Site Number:8400034</name>
      <address>
        <city>Lutherville-Timonium</city>
        <state>Maryland</state>
        <zip>21093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center-Site Number:8400072</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center-Site Number:8400143</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts-Site Number:8400014</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wayne State University-Site Number:8400046</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Michigan Institute For Neurological Disorders-Site Number:8400058</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Memorial Hospital-Site Number:8400033</name>
      <address>
        <city>Owosso</city>
        <state>Michigan</state>
        <zip>48867</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic-Site Number:8400111</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Hospital-Site Number:8400153</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sharlin Health &amp; Neurology-Site Number:8400093</name>
      <address>
        <city>Ozark</city>
        <state>Missouri</state>
        <zip>65721</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Of Nebraska-Site Number:8400129</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hackensack University Hospital-Site Number:8400047</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai (Department of Endoc-Site Number:8400038</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029-6501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurology Associates of Stony Brook-Site Number:8400042</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novant Health Multiple Sclerosis Care Center - South Park-Site Number:8400120</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Duke Neurological Disorders Clinic-Site Number:8400098</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC-Site Number:8400005</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Baptist Medical Center-Site Number:8400116</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic-Site Number:8400125</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center-Site Number:8400150</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Optimed Research, LTD-Site Number:8400147</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Providence Multiple Sclerosis Center-Site Number:8400020</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jefferson Neurology Associates-Site Number:8400016</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mountain View Clinical Research-Site Number:8400024</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651-1817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Advanced Neuroscience Center-Site Number:8400035</name>
      <address>
        <city>Franklin</city>
        <state>Tennessee</state>
        <zip>37064</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mt Olympus Medical Research-Site Number:8400163</name>
      <address>
        <city>Katy</city>
        <state>Texas</state>
        <zip>77450</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurology Center of San Antonio-Site Number:8400036</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78258</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wheaton Franciscan Healthcare-Site Number:8400022</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin-Site Number:8400028</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0320002</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1012AAR</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0320004</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1023AAB</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0320003</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0360005</name>
      <address>
        <city>Concord</city>
        <state>New South Wales</state>
        <zip>2139</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0360006</name>
      <address>
        <city>St Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0360003</name>
      <address>
        <city>Hobart</city>
        <state>Tasmania</state>
        <zip>7001</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0400004</name>
      <address>
        <city>Linz</city>
        <zip>4021</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0400002</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1120004</name>
      <address>
        <city>Vitebsk</city>
        <zip>210009</zip>
        <country>Belarus</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1120005</name>
      <address>
        <city>Vitebsk</city>
        <zip>210037</zip>
        <country>Belarus</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0560009</name>
      <address>
        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0560007</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0560003</name>
      <address>
        <city>Edegem</city>
        <zip>B-2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0560004</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0560006</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0560008</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0560002</name>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0560001</name>
      <address>
        <city>Pelt</city>
        <zip>3900</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1000002</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1000004</name>
      <address>
        <city>Sofia</city>
        <zip>1113</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1000008</name>
      <address>
        <city>Sofia</city>
        <zip>1407</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1000001</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240002</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2C8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240003</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240013</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240004</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240015</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3A 2B4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240007</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240001</name>
      <address>
        <city>Quebec</city>
        <zip>G1J 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240021</name>
      <address>
        <city>Quebec</city>
        <zip>G1W 4R4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1520006</name>
      <address>
        <city>Concepcion</city>
        <state>Biobío</state>
        <zip>4070038</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1520002</name>
      <address>
        <city>Santiago</city>
        <state>Reg Metropolitana De Santiago</state>
        <zip>7650568</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1520001</name>
      <address>
        <city>Santiago</city>
        <state>Reg Metropolitana De Santiago</state>
        <zip>8380456</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560012</name>
      <address>
        <city>Beijing</city>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560021</name>
      <address>
        <city>Beijing</city>
        <zip>100700</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560003</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560009</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560025</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560004</name>
      <address>
        <city>Changchun</city>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560015</name>
      <address>
        <city>Changsha</city>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560005</name>
      <address>
        <city>Chengdu</city>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560035</name>
      <address>
        <city>Fuzhou</city>
        <zip>350005</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560002</name>
      <address>
        <city>Guangzhou</city>
        <zip>510630</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560027</name>
      <address>
        <city>Hohhot</city>
        <zip>010050</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560001</name>
      <address>
        <city>Shanghai</city>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560008</name>
      <address>
        <city>Taiyuan</city>
        <zip>030001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560020</name>
      <address>
        <city>Tianjin</city>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560026</name>
      <address>
        <city>Wenzhou</city>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1700001</name>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1700003</name>
      <address>
        <city>Bogotá</city>
        <zip>111321</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1910001</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1910002</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2030002</name>
      <address>
        <city>Brno</city>
        <zip>65691</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2030004</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>50005</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2030001</name>
      <address>
        <city>Jihlava</city>
        <zip>58633</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2030003</name>
      <address>
        <city>Teplice</city>
        <zip>415 29</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2080001</name>
      <address>
        <city>Esbjerg</city>
        <zip>6700</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2080005</name>
      <address>
        <city>Holstebro</city>
        <zip>7500</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2330001</name>
      <address>
        <city>Tallinn</city>
        <zip>11315</zip>
        <country>Estonia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500011</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500005</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500015</name>
      <address>
        <city>Gonesse</city>
        <zip>95500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500009</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500006</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500008</name>
      <address>
        <city>Nancy</city>
        <zip>54035</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500017</name>
      <address>
        <city>Nimes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500014</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500007</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500004</name>
      <address>
        <city>Poissy</city>
        <zip>78300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500003</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500001</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500012</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2680006</name>
      <address>
        <city>Tbilisi</city>
        <zip>0112</zip>
        <country>Georgia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2680005</name>
      <address>
        <city>Tbilisi</city>
        <zip>0114</zip>
        <country>Georgia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2680003</name>
      <address>
        <city>Tbilisi</city>
        <zip>0160</zip>
        <country>Georgia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2680004</name>
      <address>
        <city>Tbilisi</city>
        <zip>0172</zip>
        <country>Georgia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760005</name>
      <address>
        <city>Bayreuth</city>
        <zip>95445</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760009</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760015</name>
      <address>
        <city>Berlin</city>
        <zip>10713</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760020</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760001</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760021</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760012</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760002</name>
      <address>
        <city>Gießen</city>
        <zip>35385</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760010</name>
      <address>
        <city>Halle (Saale)</city>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760006</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760018</name>
      <address>
        <city>München</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760008</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760004</name>
      <address>
        <city>Rostock</city>
        <zip>18055</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760011</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3000001</name>
      <address>
        <city>Athens</city>
        <zip>115 28</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3000006</name>
      <address>
        <city>Athens</city>
        <zip>11535</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3000002</name>
      <address>
        <city>Athens</city>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3000007</name>
      <address>
        <city>Athens</city>
        <zip>15125</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3000004</name>
      <address>
        <city>Larissa</city>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3000003</name>
      <address>
        <city>Thessaloniki</city>
        <zip>546 36</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3000009</name>
      <address>
        <city>Thessaloniki</city>
        <zip>55236</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3480202</name>
      <address>
        <city>Budapest</city>
        <zip>1145</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3480205</name>
      <address>
        <city>Budapest</city>
        <zip>1152</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3480204</name>
      <address>
        <city>Kistarcsa</city>
        <zip>2143</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3480203</name>
      <address>
        <city>Tatabánya</city>
        <zip>2800</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560007</name>
      <address>
        <city>Gurgaon</city>
        <zip>122001</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560003</name>
      <address>
        <city>Gurgaon</city>
        <zip>122002</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560004</name>
      <address>
        <city>Mangaluru</city>
        <zip>575018</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560005</name>
      <address>
        <city>New Delhi</city>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560002</name>
      <address>
        <city>New Delhi</city>
        <zip>110060</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3760002</name>
      <address>
        <city>Ashkelon</city>
        <zip>78278</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3760008</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3760001</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3760004</name>
      <address>
        <city>Safed</city>
        <zip>13100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800002</name>
      <address>
        <city>Pozzilli</city>
        <state>Isernia</state>
        <zip>86077</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800007</name>
      <address>
        <city>Cagliari</city>
        <zip>09126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800015</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800018</name>
      <address>
        <city>Chieti</city>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800016</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800001</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800003</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800006</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800004</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800013</name>
      <address>
        <city>Roma</city>
        <zip>00189</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920016</name>
      <address>
        <city>Chiba-shi</city>
        <state>Chiba</state>
        <zip>260-8677</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920008</name>
      <address>
        <city>Koriyama-shi</city>
        <state>Fukushima</state>
        <zip>963-8052</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920022</name>
      <address>
        <city>Morioka-shi</city>
        <state>Iwate</state>
        <zip>020-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920011</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>616-8255</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920020</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920005</name>
      <address>
        <city>Niigata-shi</city>
        <state>Niigata</state>
        <zip>951-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920004</name>
      <address>
        <city>Moriguchi-shi</city>
        <state>Osaka</state>
        <zip>570-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920001</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <zip>556-0016</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920018</name>
      <address>
        <city>Kawagoe-shi</city>
        <state>Saitama</state>
        <zip>350-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920014</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920003</name>
      <address>
        <city>Kodaira-shi</city>
        <state>Tokyo</state>
        <zip>187-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920010</name>
      <address>
        <city>Ota-ku</city>
        <state>Tokyo</state>
        <zip>146-0065</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920017</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920015</name>
      <address>
        <city>Toyama-shi</city>
        <state>Toyama</state>
        <zip>930-0194</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920023</name>
      <address>
        <city>Sagamihara-shi</city>
        <zip>252-0392</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :4280002</name>
      <address>
        <city>Riga</city>
        <zip>LV-1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :4280003</name>
      <address>
        <city>Riga</city>
        <zip>LV-1005</zip>
        <country>Latvia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :4840004</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44670</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :4840001</name>
      <address>
        <city>Cdmx</city>
        <state>México</state>
        <zip>06700</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :4840005</name>
      <address>
        <city>Cdmx</city>
        <state>México</state>
        <zip>14050</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :4840007</name>
      <address>
        <city>Tlalnepantla</city>
        <zip>54055</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :4840003</name>
      <address>
        <city>Veracruz</city>
        <zip>91910</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5280003</name>
      <address>
        <city>Breda</city>
        <zip>4818 CK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5280006</name>
      <address>
        <city>Groningen</city>
        <zip>9728 NZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5280002</name>
      <address>
        <city>Sittard-Geleen</city>
        <zip>6162 BG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5780003</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5780005</name>
      <address>
        <city>Tromsø</city>
        <zip>9038</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6040004</name>
      <address>
        <city>Lima</city>
        <zip>15084</zip>
        <country>Peru</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6160003</name>
      <address>
        <city>Bydgoszcz</city>
        <state>Kujawsko-pomorskie</state>
        <zip>85-796</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6160001</name>
      <address>
        <city>Lodz</city>
        <state>Lódzkie</state>
        <zip>90-549</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6160005</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>01-211</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6160006</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>01-684</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6160002</name>
      <address>
        <city>Katowice</city>
        <state>Slaskie</state>
        <zip>40-571</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6160007</name>
      <address>
        <city>Katowice</city>
        <state>Slaskie</state>
        <zip>40-684</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6160004</name>
      <address>
        <city>Katowice</city>
        <state>Slaskie</state>
        <zip>40-686</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200001</name>
      <address>
        <city>Braga</city>
        <zip>4710-243</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200016</name>
      <address>
        <city>Leiria</city>
        <zip>2410-197</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200007</name>
      <address>
        <city>Lisboa</city>
        <zip>1349-019</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200012</name>
      <address>
        <city>Lisboa</city>
        <zip>1500-650</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200002</name>
      <address>
        <city>Matosinhos</city>
        <zip>4464-513</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200010</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200004</name>
      <address>
        <city>Santa Maria da Feira</city>
        <zip>4520-211</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6420008</name>
      <address>
        <city>Bucuresti</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6420004</name>
      <address>
        <city>Campulung</city>
        <zip>115100</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6420003</name>
      <address>
        <city>Constanta</city>
        <zip>900123</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6420013</name>
      <address>
        <city>Oradea</city>
        <zip>410154</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6420001</name>
      <address>
        <city>Targu Mures</city>
        <zip>540136</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6420002</name>
      <address>
        <city>Timisoara</city>
        <zip>300736</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430018</name>
      <address>
        <city>Barnaul</city>
        <zip>656024</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430022</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620102</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430023</name>
      <address>
        <city>Kaliningrad</city>
        <zip>236035</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430004</name>
      <address>
        <city>Kazan</city>
        <zip>420032</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430021</name>
      <address>
        <city>Krasnoyarsk</city>
        <zip>660029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430013</name>
      <address>
        <city>Moscow</city>
        <zip>117997</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430011</name>
      <address>
        <city>Moscow</city>
        <zip>129128</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430014</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603137</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430008</name>
      <address>
        <city>Pyatigorsk</city>
        <zip>357538</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430015</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430017</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197376</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430009</name>
      <address>
        <city>Samara</city>
        <zip>443095</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430020</name>
      <address>
        <city>Saransk</city>
        <zip>430032</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430007</name>
      <address>
        <city>Tyumen</city>
        <zip>625000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430006</name>
      <address>
        <city>Ufa</city>
        <zip>450005</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6880001</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6880002</name>
      <address>
        <city>Kragujevac</city>
        <zip>34000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6880004</name>
      <address>
        <city>Nis</city>
        <zip>18000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7100001</name>
      <address>
        <city>Pretoria</city>
        <zip>0041</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240012</name>
      <address>
        <city>La Coruña</city>
        <state>A Coruña [La Coruña]</state>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240015</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>A Coruña [La Coruña]</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240007</name>
      <address>
        <city>Sevilla</city>
        <state>Andalucia</state>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240010</name>
      <address>
        <city>Barcelona</city>
        <state>Barcelona [Barcelona]</state>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240013</name>
      <address>
        <city>Bilbao</city>
        <state>Bizkaia</state>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240011</name>
      <address>
        <city>Salt</city>
        <state>Girona [Gerona]</state>
        <zip>17190</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240016</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <state>Las Palmas</state>
        <zip>35010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240002</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240001</name>
      <address>
        <city>Pozuelo De Alarcón</city>
        <state>Madrid</state>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240004</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240003</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240005</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240006</name>
      <address>
        <city>Murcia</city>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240014</name>
      <address>
        <city>Palma de Mallorca</city>
        <zip>07120</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240008</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7520001</name>
      <address>
        <city>Göteborg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7520005</name>
      <address>
        <city>Motala</city>
        <zip>591 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7560003</name>
      <address>
        <city>Aarau</city>
        <zip>5001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7560002</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920009</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920014</name>
      <address>
        <city>Ankara</city>
        <zip>06500</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920005</name>
      <address>
        <city>Eskisehir</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920010</name>
      <address>
        <city>Hatay</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920016</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920002</name>
      <address>
        <city>Istanbul</city>
        <zip>34303</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920007</name>
      <address>
        <city>Istanbul</city>
        <zip>34785</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920006</name>
      <address>
        <city>Istanbul</city>
        <zip>34896</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920003</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920015</name>
      <address>
        <city>Izmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920001</name>
      <address>
        <city>Izmit</city>
        <zip>41380</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920011</name>
      <address>
        <city>Kutahya</city>
        <zip>43100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920012</name>
      <address>
        <city>Mersin</city>
        <zip>33070</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920013</name>
      <address>
        <city>Samsun</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920008</name>
      <address>
        <city>Trabzon</city>
        <zip>61080</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040020</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58023</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040022</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040012</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76493</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040017</name>
      <address>
        <city>Kharkiv</city>
        <zip>61068</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040025</name>
      <address>
        <city>Kharkiv</city>
        <zip>61068</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040014</name>
      <address>
        <city>Kharkiv</city>
        <zip>61103</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040023</name>
      <address>
        <city>Kharkiv</city>
        <zip>61103</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040013</name>
      <address>
        <city>Kyiv</city>
        <zip>02091</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040015</name>
      <address>
        <city>Kyiv</city>
        <zip>03115</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040011</name>
      <address>
        <city>Lutsk</city>
        <zip>43005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040002</name>
      <address>
        <city>Lviv</city>
        <zip>79010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040007</name>
      <address>
        <city>Lviv</city>
        <zip>79013</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040010</name>
      <address>
        <city>Odesa</city>
        <zip>65025</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040004</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040024</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040008</name>
      <address>
        <city>Zhytormyr</city>
        <zip>10002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260006</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>EC1M 6BQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260005</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260010</name>
      <address>
        <city>Swansea</city>
        <state>Neath Port Talbot</state>
        <zip>SA6 6NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260012</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260013</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260001</name>
      <address>
        <city>Cardiff</city>
        <state>Vale Of Glamorgan, The</state>
        <zip>CF4 4XY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260019</name>
      <address>
        <city>Salford</city>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belarus</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>China</country>
    <country>Colombia</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Latvia</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Peru</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 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>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Chronic Progressive</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </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/NCT04458051
org study id: EFC16035
secondary id: U1111-1238-1318
nct id: NCT04458051
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Primary Objective:

      To determine the efficacy of SAR442168 compared to placebo in delaying disability progression
      in primary progressive multiple sclerosis (PPMS)

      Secondary Objectives:

      To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic
      resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of
      life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics
      (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate
      pharmacodynamics of SAR442168
Study duration will vary per participant in this event driven trial with a treatment duration
      of approximately 24 to 48 months.

      Participants completing the treatment period will be proposed to enroll in a separate long
      term safety study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: 6 month Confirmed Disability Progression (CDP)
time frame: Up to approximately 48 months
description: Time to onset of 6 month CDP defined as follows:
Increase of ≥1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is ≤5.5, or Increase of ≥0.5 points when the baseline EDSS score is >5.5
measure: 3-month confirmed disability progression (CDP)
time frame: Up to approximately 48 months
description: Time to onset of 3-month CDP as assessed by EDSS score
measure: 3-month change in 9-hole peg test (9-HPT)
time frame: Up to approximately 48 months
description: Time to onset of sustained 20% increase in the 9-HPT test confirmed over at least 3 months
measure: 3-month change in timed 25 foot walk (T25-FW)
time frame: Up to approximately 48 months
description: Time to onset of sustained 20% increase in the T25-FW confirmed over at least 3 months
measure: Change in T2 hyperintense lesions by MRI
time frame: From Baseline up to 48 approximately months
description: Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI after baseline up to and including the end of study (EOS)
measure: Time to onset of confirmed disability improvement (CDI)
time frame: From Baseline up to 48 approximately months
description: Time to onset of CDI defined as ≥1.0 point decrease on the EDSS score from baseline confirmed over at least 6 months
measure: Percent change in Brain volume loss (BVL)
time frame: From 6 months up to approximately 48 months -
description: Percent change in brain volume loss (BVL) as detected by brain MRI at the EOS compared to month 6
measure: Change in cognitive function as assessed by the Symbol Digit Modalities Test (SDMT)
time frame: From Baseline up to approximately 48 months
description: Change in cognitive function at the EOS compared to baseline as assessed by the SDMT
measure: Change in cognitive function as assessed by the California Verbal Learning Test II (CVLT-II)
time frame: From Baseline up to approximately 48 months
description: Change in cognitive function at the EOS compared to baseline as assessed by the CVLT-II
measure: Change in Multiple Sclerosis Quality of Life
time frame: From Baseline up to approximately 48 months
description: Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) at the EOS compared to baseline
measure: Safety and Tolerability
time frame: From screening up to approximately 48 months
description: Number of participants with adverse events (AEs), Serious AEs, AEs leading to permanent study intervention discontinuation, and adverse events of special interest (AESI)
measure: Population pharmacokinetics
time frame: Months 6, 9 and 12
description: Plasma concentration of SAR442168 (population PK assessment) at Months 6, 9, and 12
measure: Change in plasma neurofilament light chain (NfL)
time frame: From Baseline up to approximately 48 months
description: Change in NfL levels from at the EOS compared to baseline
measure: Change in lymphocyte phenotype subsets
time frame: From Baseline up to approximately 48 months
description: Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline in a subset of participants
measure: Changes in serum Immunoglobulin level
time frame: From Baseline up to approximately 48 months
description: Changes in serum Immunoglobulin level at the EOS compared to baseline
measure: Change in serum chitinase-3 like protein 1 (Chi3L1)
time frame: From Baseline up to approximately 48 months -
description: Change in serum chitinase-3 like protein 1 (Chi3L1) from baseline to EOS
arm group label: SAR442168
arm group type: Experimental
description: Dose 1 of oral SAR442168 daily
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo to match the SAR442168 daily
intervention type: Drug
intervention name: Tolebrutinib
description: Pharmaceutical form: Film-coated Tablet Route of administration: Oral
arm group label: SAR442168
other name: SAR442168
intervention type: Drug
intervention name: Placebo
description: Pharmaceutical form: Film-coated Tablet Route of administration: Oral
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
last name: Trial Transparency email recommended (Toll free number for US & Canada)
phone: 800-633-1610
phone ext: option 6
email: Contact-US@sanofi.com
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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facility: 
status: Completed
facility: 
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status: Recruiting
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status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
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status: Active, not recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Argentina
country: Australia
country: Austria
country: Belarus
country: Belgium
country: Bulgaria
country: Canada
country: Chile
country: China
country: Colombia
country: Croatia
country: Czechia
country: Denmark
country: Estonia
country: France
country: Georgia
country: Germany
country: Greece
country: Hungary
country: India
country: Israel
country: Italy
country: Japan
country: Latvia
country: Mexico
country: Netherlands
country: Norway
country: Peru
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Serbia
country: South Africa
country: Spain
country: Sweden
country: Switzerland
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Chronic Progressive
mesh term: Sclerosis
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org