<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/NCT02218879</url>
  </required_header>
  <id_info>
    <org_study_id>1403013581</org_study_id>
    <nct_id>NCT02218879</nct_id>
  </id_info>
  <brief_title>Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS</brief_title>
  <official_title>Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With Relapsing-Remitting Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to directly estimate brain glutathione concentrations in vivo using&#xD;
      H-MRS at 7T before and after initiation of Tecfidera in established multiple sclerosis (MS)&#xD;
      patients considering switching therapy or being treatment-naive (first line).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Glutathione Concentrations In Normal Appearing Gray Matter in Brain Measured by 7T Magnetic Resonance Imaging Scan</measure>
    <time_frame>Before and 12 months after Tecfidera Initiation</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">7</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Patients with relapsing MS</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tecfidera</intervention_name>
    <description>Oral Tecfidera 240 mg bid</description>
    <arm_group_label>Patients with relapsing MS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a relapsing form of MS&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female adult patients&#xD;
&#xD;
          -  18-60 years of age&#xD;
&#xD;
          -  Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria&#xD;
             (2010)&#xD;
&#xD;
          -  Patients naive to MS therapy or patients switching from an FDA-approved MS therapy,&#xD;
             including IFN-B formulations, Cop-1, Teriflunomide, and Fingolimod to BG-12&#xD;
&#xD;
          -  Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary progressive multiple sclerosis patients&#xD;
&#xD;
          -  Patients with previous exposure or known allergies to fumarates&#xD;
&#xD;
          -  MS patients switching from natalizumab, cyclophosphamide, or mitoxantrone to BG-12&#xD;
&#xD;
          -  Contraindications for MRI/MRS&#xD;
&#xD;
          -  Known presence of other neurological disorders that may mimic multiple sclerosis&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Requirement for chronic treatment with systemic corticosteroids or immunosuppressants&#xD;
             during the course of the study&#xD;
&#xD;
          -  History of or currently active primary or secondary immunodeficiency&#xD;
&#xD;
          -  Active infection, or history of or known presence of recurrent or chronic infection&#xD;
             (e.g. hepatitis B or C, HIV, syphilis, tuberculosis_&#xD;
&#xD;
          -  History of progressive multifocal leukoencephalopathy&#xD;
&#xD;
          -  Contraindications to or intolerance of oral or intravenous (IV) corticosteroids&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Pelletier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>September 2, 2016</last_update_submitted>
  <last_update_submitted_qc>September 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2016</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>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dimethyl Fumarate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02218879
org study id: 1403013581
nct id: NCT02218879
lead sponsor: 
has dmc: No
The primary objective is to directly estimate brain glutathione concentrations in vivo using
      H-MRS at 7T before and after initiation of Tecfidera in established multiple sclerosis (MS)
      patients considering switching therapy or being treatment-naive (first line).
observational model: Cohort
time perspective: Prospective
measure: Change in Glutathione Concentrations In Normal Appearing Gray Matter in Brain Measured by 7T Magnetic Resonance Imaging Scan
time frame: Before and 12 months after Tecfidera Initiation
arm group label: Patients with relapsing MS
intervention type: Drug
intervention name: Tecfidera
description: Oral Tecfidera 240 mg bid
arm group label: Patients with relapsing MS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Daniel Pelletier, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Dimethyl Fumarate