<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/NCT02217982</url>
  </required_header>
  <id_info>
    <org_study_id>009-001-TEC</org_study_id>
    <nct_id>NCT02217982</nct_id>
  </id_info>
  <brief_title>Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation</brief_title>
  <acronym>IIT9</acronym>
  <official_title>A Pilot Study to Assess Dimethyl Fumarate (Tecfidera) Related GI Symptom Mitigation Via Food Bolus Alteration and Simethicone/Loperamide Administration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rocky Mountain MS Research Group, LLC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biogen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Rocky Mountain MS Research Group, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Single site, open label, randomized design in patients with relapsing forms of Multiple&#xD;
      Sclerosis. At the Screening Visit, the patient will be given a diary containing the MAGIS&#xD;
      scale to be completed once a day for the first two weeks while on Dimethyl Fumarate (DMF),&#xD;
      including the titration period.&#xD;
&#xD;
      After two weeks or if a patient experiences 3 or more consecutive days of GI symptoms in any&#xD;
      category of ≥3.5, the patient will return for a Baseline Visit. The MAGIS diary will be&#xD;
      reviewed by the coordinator. Any patient who has reported an average MAGIS score of greater&#xD;
      than or equal to 3.5 in at least one of the key categories will be randomized to a standard&#xD;
      therapy or treatment arm. Patients who report a MAGIS of less than 3.5 during this period&#xD;
      will be terminated from the study at this visit. Patients with an average reported MAGIS of&#xD;
      greater than 6.5 at Baseline will be placed in the treatment arm.&#xD;
&#xD;
      Patients who are randomized to the treatment arm will be instructed to take 125 mg&#xD;
      simethicone and one tablespoon of a high fat food (peanut butter) 10 minutes prior to each&#xD;
      DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will&#xD;
      also be instructed to take 2 mg loperamide three times daily.&#xD;
&#xD;
      Patients randomized to the standard therapy arm will be instructed to follow the normal&#xD;
      dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms&#xD;
      (MAGIS &gt;6.5) are noted at any time post randomization in any MAGIS category, crossover to the&#xD;
      treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the&#xD;
      past 24 hours using the MAGIS scale once daily.&#xD;
&#xD;
      Both treatment arms will be observed for 6 weeks. MAGIS will be recorded once daily. Patients&#xD;
      will return to the clinic at Week 3 and Week 6/End of Treatment for diary and compliance&#xD;
      review. After Week 6, patients will be instructed to return to a standard therapy. MAGIS will&#xD;
      be recorded for one more week and collected at Week 7/End of Study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study did not meet required enrollment numbers&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reported GI Symptoms</measure>
    <time_frame>7 Weeks</time_frame>
    <description>The primary endpoint will be severity of GI events as measured by the MAGIS scale for subjects in the treatment arm compared to the standard therapy arm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diarrhea Reduction</measure>
    <time_frame>7 Weeks</time_frame>
    <description>The secondary objective is to assess the reduction in diarrhea in the treatment group compared to the control.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Pre-Existing GI Conditions</measure>
    <time_frame>7 Weeks</time_frame>
    <description>The tertiary objective is to gather further data regarding pre-existing conditions (GE reflex, gastric bypass, stomach ulcer, etc) and their possible relationship to GI symptoms when initiating DMF.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Relapsing Remitting Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS &gt;6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simethicone</intervention_name>
    <arm_group_label>Treatment Arm</arm_group_label>
    <other_name>Gas-X</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Loperamide</intervention_name>
    <arm_group_label>Treatment Arm</arm_group_label>
    <other_name>Imodium</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peanut Butter</intervention_name>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Decision to treat with DMF must precede enrollment&#xD;
&#xD;
          2. Ability to understand the purpose and risk of the study and provide authorization for&#xD;
             the use of protected health information in accordance with the monitoring agency&#xD;
&#xD;
          3. Men or women 18 years of age or older at the time of informed consent&#xD;
&#xD;
          4. Naïve to DMF or fumaric acid esters&#xD;
&#xD;
          5. Confirmed diagnosis of a relapsing form of multiple sclerosis as verified by the&#xD;
             Principal Investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to unwilling to comply with study requirements as outlined in the informed&#xD;
             consent&#xD;
&#xD;
          2. Known active malignancies or any other major comorbidities that, in the opinion of the&#xD;
             Investigator, would affect the outcome of the study&#xD;
&#xD;
          3. Pregnant or breastfeeding or likely to become pregnant during the course of the study.&#xD;
             Women of child-bearing potential must practice an acceptable form of birth control&#xD;
&#xD;
          4. Previous treatment with dimethyl fumarate&#xD;
&#xD;
          5. Past history of GI malignancy, gastric ulceration refractory to medical resolution,&#xD;
             history of gastrectomy. At the discretion of the PI, resolved GI ulceration,&#xD;
             gastroesophageal reflux will not be exclusionary&#xD;
&#xD;
          6. Known sensitivity or allergic reaction to peanuts, simethicone, or loperamide&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John F Foley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rocky Mountain MS Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rocky Mountain MS Research Group</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <results_first_submitted>November 8, 2016</results_first_submitted>
  <results_first_submitted_qc>November 8, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 6, 2017</results_first_posted>
  <last_update_submitted>February 20, 2017</last_update_submitted>
  <last_update_submitted_qc>February 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rocky Mountain MS Research Group, LLC</investigator_affiliation>
    <investigator_full_name>John F. Foley, MD</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </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, Relapsing-Remitting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Simethicone</mesh_term>
    <mesh_term>Loperamide</mesh_term>
    <mesh_term>Antidiarrheals</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control Group</title>
          <description>Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS &gt;6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.</description>
        </group>
        <group group_id="P2">
          <title>Treatment Arm</title>
          <description>Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.&#xD;
Simethicone&#xD;
Loperamide&#xD;
Peanut Butter</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0">Trial closed before patient finished</participants>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Trial discontinued</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>5 patients total qualified for the trial after monitoring of GI symptoms after initiation of DMF</population>
      <group_list>
        <group group_id="B1">
          <title>Control Group</title>
          <description>Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS &gt;6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.</description>
        </group>
        <group group_id="B2">
          <title>Treatment Arm</title>
          <description>Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.&#xD;
Simethicone&#xD;
Loperamide&#xD;
Peanut Butter</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Reported GI Symptoms</title>
        <description>The primary endpoint will be severity of GI events as measured by the MAGIS scale for subjects in the treatment arm compared to the standard therapy arm.</description>
        <time_frame>7 Weeks</time_frame>
        <population>Trial was shut down early as not enough patients qualified with GI symptoms their first 2 weeks after initiating DMF therapy</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS &gt;6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Arm</title>
            <description>Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.&#xD;
Simethicone&#xD;
Loperamide&#xD;
Peanut Butter</description>
          </group>
        </group_list>
        <measure>
          <title>Reported GI Symptoms</title>
          <description>The primary endpoint will be severity of GI events as measured by the MAGIS scale for subjects in the treatment arm compared to the standard therapy arm.</description>
          <population>Trial was shut down early as not enough patients qualified with GI symptoms their first 2 weeks after initiating DMF therapy</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diarrhea Reduction</title>
        <description>The secondary objective is to assess the reduction in diarrhea in the treatment group compared to the control.</description>
        <time_frame>7 Weeks</time_frame>
        <population>Not enough patients qualified and the study was terminated early.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS &gt;6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Arm</title>
            <description>Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.&#xD;
Simethicone&#xD;
Loperamide&#xD;
Peanut Butter</description>
          </group>
        </group_list>
        <measure>
          <title>Diarrhea Reduction</title>
          <description>The secondary objective is to assess the reduction in diarrhea in the treatment group compared to the control.</description>
          <population>Not enough patients qualified and the study was terminated early.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Pre-Existing GI Conditions</title>
        <description>The tertiary objective is to gather further data regarding pre-existing conditions (GE reflex, gastric bypass, stomach ulcer, etc) and their possible relationship to GI symptoms when initiating DMF.</description>
        <time_frame>7 Weeks</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>approximately 10 weeks from consent to end of study</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control Group</title>
          <description>Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS &gt;6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.</description>
        </group>
        <group group_id="E2">
          <title>Treatment Arm</title>
          <description>Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.&#xD;
Simethicone&#xD;
Loperamide&#xD;
Peanut Butter</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This trial was closed down early because the anticipated number of patients experiencing GI symptoms was not met - therefore not enough patients qualified for the treatment and control arms for analysis.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Tammy Hoyt</name_or_title>
      <organization>Rocky Mountain MS Research Group</organization>
      <phone>8014085711</phone>
      <email>thoyt@rmmsc.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02217982
org study id: 009-001-TEC
nct id: NCT02217982
lead sponsor: 
collaborator: 
has dmc: No
Single site, open label, randomized design in patients with relapsing forms of Multiple
      Sclerosis. At the Screening Visit, the patient will be given a diary containing the MAGIS
      scale to be completed once a day for the first two weeks while on Dimethyl Fumarate (DMF),
      including the titration period.

      After two weeks or if a patient experiences 3 or more consecutive days of GI symptoms in any
      category of ≥3.5, the patient will return for a Baseline Visit. The MAGIS diary will be
      reviewed by the coordinator. Any patient who has reported an average MAGIS score of greater
      than or equal to 3.5 in at least one of the key categories will be randomized to a standard
      therapy or treatment arm. Patients who report a MAGIS of less than 3.5 during this period
      will be terminated from the study at this visit. Patients with an average reported MAGIS of
      greater than 6.5 at Baseline will be placed in the treatment arm.

      Patients who are randomized to the treatment arm will be instructed to take 125 mg
      simethicone and one tablespoon of a high fat food (peanut butter) 10 minutes prior to each
      DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will
      also be instructed to take 2 mg loperamide three times daily.

      Patients randomized to the standard therapy arm will be instructed to follow the normal
      dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms
      (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the
      treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the
      past 24 hours using the MAGIS scale once daily.

      Both treatment arms will be observed for 6 weeks. MAGIS will be recorded once daily. Patients
      will return to the clinic at Week 3 and Week 6/End of Treatment for diary and compliance
      review. After Week 6, patients will be instructed to return to a standard therapy. MAGIS will
      be recorded for one more week and collected at Week 7/End of Study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reported GI Symptoms
time frame: 7 Weeks
description: The primary endpoint will be severity of GI events as measured by the MAGIS scale for subjects in the treatment arm compared to the standard therapy arm.
measure: Diarrhea Reduction
time frame: 7 Weeks
description: The secondary objective is to assess the reduction in diarrhea in the treatment group compared to the control.
measure: Number of Participants With Pre-Existing GI Conditions
time frame: 7 Weeks
description: The tertiary objective is to gather further data regarding pre-existing conditions (GE reflex, gastric bypass, stomach ulcer, etc) and their possible relationship to GI symptoms when initiating DMF.
arm group label: Control Group
arm group type: No Intervention
description: Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
arm group label: Treatment Arm
arm group type: Active Comparator
description: Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.
intervention type: Drug
intervention name: Simethicone
arm group label: Treatment Arm
other name: Gas-X
intervention type: Drug
intervention name: Loperamide
arm group label: Treatment Arm
other name: Imodium
intervention type: Other
intervention name: Peanut Butter
arm group label: Treatment Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John F Foley, MD
role: Principal Investigator
affiliation: Rocky Mountain MS Research Group
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rocky Mountain MS Research Group, LLC
investigator full name: John F. Foley, MD
investigator title: PI
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Simethicone
mesh term: Loperamide
mesh term: Antidiarrheals
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This trial was closed down early because the anticipated number of patients experiencing GI symptoms was not met - therefore not enough patients qualified for the treatment and control arms for analysis.
point of contact: 