xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05978531</url>
    </required_header>
    <id_info>
      <org_study_id>BLS-11-404</org_study_id>
      <nct_id>NCT05978531</nct_id>
    </id_info>
    <brief_title>Observational Study of Persistence on Bafiertam Treatment In Routine Clinical Practice</brief_title>
    <acronym>SIMPLE</acronym>
    <official_title>A Prospective, Observational Study of Bafiertam Evaluating Persistence on Treatment, Safety, Tolerability, And Effectiveness In Routine Clinical Practice.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Banner Life Sciences LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Banner Life Sciences LLC</source>
    <oversight_info>
      <has_dmc>No</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>
        This is an open-label, multicenter, observational study of the adherence of patients with&#xD;
        relapsing-remitting multiple sclerosis (RRMS) prescribed Bafiertam (monomethyl fumarate) as&#xD;
        their treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Monomethyl fumarate (MMF) is the active metabolite of the fumarate class of drugs used for&#xD;
        the treatment of RRMS. Bafiertam is a formulation of MMF and does not require enzymatic&#xD;
        conversion after oral administration. Adult participants with a diagnosis of RRMS who have&#xD;
        been receiving continuous treatment with Bafiertam monotherapy per the approved product label&#xD;
        for no more than 3 months (90 days) are eligible to enroll in the study. Their satisfaction&#xD;
        with Bafiertam treatment will be assessed using a 9-Item Treatment Satisfaction Questionnaire&#xD;
        for Medication (TSQM-9). To be included in the study, patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 17, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of participants on treatment with Bafiertam at 1 Year.</measure>
      <time_frame>12 months</time_frame>
      <description>Percentage of participants on treatment with Bafiertam at 1 Year.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants on Treatment with Bafiertam at 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Percentage of Participants on Treatment with Bafiertam at 6 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Satisfaction Questionnaire for Medication (TSQM-9)</measure>
      <time_frame>12 months</time_frame>
      <description>Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score (range 0 - 100) at Month 6 and 12 months.TSQM Version 9 is comprised of 9 questions that provide scores on four scales: effectiveness (3 items), convenience (3 items), and global satisfaction (3 items). The scale scores are transformed and range from 0 to 100. Higher scores indicate greater satisfaction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation.</measure>
      <time_frame>12 months</time_frame>
      <description>Number of Participants with AEs Leading to Treatment Discontinuation.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Relapsing Remitting Multiple Sclerosis</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Monomethyl Fumarate</intervention_name>
      <description>95 mg oral capsule, 190 mg (2 x 95 mg) twice daily</description>
      <other_name>Bafiertam</other_name>
      <other_name>BLS-11</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will be selected from existing patients known to the individual&#xD;
          investigators.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or non-pregnant female aged 18 years and older.&#xD;
  &#xD;
            2. Participants diagnosed with Relapsing forms of multiple sclerosis R(RMS) and satisfy&#xD;
               the approved therapeutic indication for Bafiertam per the approved product labeling.&#xD;
  &#xD;
            3. Participants may enroll if they are within 90 days of initiating therapy with&#xD;
               Bafiertam.&#xD;
  &#xD;
            4. Female participants of childbearing potential must practice effective contraception&#xD;
               from Day -1 and be willing and able to continue contraception for the duration of the&#xD;
               study.&#xD;
  &#xD;
            5. Willing and able to sign the informed consent form (ICF) approved by the Institutional&#xD;
               Review Board (IRB).&#xD;
  &#xD;
            6. Willing and able to complete all the study procedures and communicate meaningfully&#xD;
               with study personnel.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Known hypersensitivity to fumarates including dimethyl fumarate, Tecfidera, and/or&#xD;
               diroximel fumarate (Vumerity) or Bafiertam.&#xD;
  &#xD;
            2. Participated in another clinical trial within 30 days, suffered or still recovering&#xD;
               from a medically significant event of surgery within 30 days, or previously&#xD;
               participated in a clinical study with a similar investigational product.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Arizona Neuroscience Research, LLC</name>
        <address>
          <city>Phoenix</city>
          <state>Arizona</state>
          <zip>85032</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Regina Berkovich, MD, PhD Inc.</name>
        <address>
          <city>West Hollywood</city>
          <state>California</state>
          <zip>90048</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Caribbean Center for Clinical Research</name>
        <address>
          <city>Guaynabo</city>
          <zip>00968</zip>
          <country>Puerto Rico</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Puerto Rico</country>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 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, Relapsing-Remitting</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05978531
  org study id: BLS-11-404
  nct id: NCT05978531
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This is an open-label, multicenter, observational study of the adherence of patients with
        relapsing-remitting multiple sclerosis (RRMS) prescribed Bafiertam (monomethyl fumarate) as
        their treatment.
  Monomethyl fumarate (MMF) is the active metabolite of the fumarate class of drugs used for
        the treatment of RRMS. Bafiertam is a formulation of MMF and does not require enzymatic
        conversion after oral administration. Adult participants with a diagnosis of RRMS who have
        been receiving continuous treatment with Bafiertam monotherapy per the approved product label
        for no more than 3 months (90 days) are eligible to enroll in the study. Their satisfaction
        with Bafiertam treatment will be assessed using a 9-Item Treatment Satisfaction Questionnaire
        for Medication (TSQM-9). To be included in the study, patients.
  observational model: Case-Only
  time perspective: Prospective
  measure: Percentage of participants on treatment with Bafiertam at 1 Year.
  time frame: 12 months
  description: Percentage of participants on treatment with Bafiertam at 1 Year.
  measure: Percentage of Participants on Treatment with Bafiertam at 6 months
  time frame: 6 months
  description: Percentage of Participants on Treatment with Bafiertam at 6 months
  measure: Treatment Satisfaction Questionnaire for Medication (TSQM-9)
  time frame: 12 months
  description: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score (range 0 - 100) at Month 6 and 12 months.TSQM Version 9 is comprised of 9 questions that provide scores on four scales: effectiveness (3 items), convenience (3 items), and global satisfaction (3 items). The scale scores are transformed and range from 0 to 100. Higher scores indicate greater satisfaction.
  measure: Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation.
  time frame: 12 months
  description: Number of Participants with AEs Leading to Treatment Discontinuation.
  intervention type: Drug
  intervention name: Monomethyl Fumarate
  description: 95 mg oral capsule, 190 mg (2 x 95 mg) twice daily
  other name: Bafiertam
  other name: BLS-11
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  country: Puerto Rico
  country: United States
  responsible party type: Sponsor
  mesh term: Multiple Sclerosis
  mesh term: Multiple Sclerosis, Relapsing-Remitting
  sharing ipd: No