<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/NCT03302806</url>
  </required_header>
  <id_info>
    <org_study_id>RC16_0232</org_study_id>
    <nct_id>NCT03302806</nct_id>
  </id_info>
  <brief_title>Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis</brief_title>
  <acronym>BIOSEP</acronym>
  <official_title>Observational Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this observational study is to collect efficacy and safety data in real life&#xD;
      condition within the first year of treatment in patients with progressive multiple receiving&#xD;
      a daily dose of biotine of 300 mg.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2016</start_date>
  <completion_date type="Actual">October 24, 2018</completion_date>
  <primary_completion_date type="Actual">October 4, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of post-treatment disability</measure>
    <time_frame>12 months</time_frame>
    <description>Change in Expanded Disability Status Scale (EDSS) progression from pretreatment period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CGI-t scale</measure>
    <time_frame>after 6 months and 12 months</time_frame>
    <description>Change in Clinical global impression of improvement from both physician and patient assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional disability : Multiple sclerosis Functional composite</measure>
    <time_frame>12 months</time_frame>
    <description>Composite score : Change in test measuring the patient's walking speed over a distance of 25 feet(TW25), Symbol Digit Modalities Test (SDMT), 9-Hole Peg Test Scores (9HPT) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulation</measure>
    <time_frame>12 months</time_frame>
    <description>Change in MSWS-12 score from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>12 months</time_frame>
    <description>Composite score : Change in EQ5D, MusiQuol, TLS coping 10 score from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse effect (adverse drug reaction)</measure>
    <time_frame>12 months</time_frame>
    <description>number of AE</description>
  </secondary_outcome>
  <enrollment type="Actual">103</enrollment>
  <condition>Progressive Multiple Sclerosis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non interventional Study</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with progressive multiple receiving a daily dose of biotine of 300 mg&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Progressive multiple sclerosis patients with an EDSS score ≤ 7 who have been&#xD;
             prescribed high dose of biotin (temporary use administration) at Nantes university&#xD;
             hospital (France)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with remittent recurrent multiple sclerosis&#xD;
&#xD;
          -  Pregnant women or women contemplating pregnancy&#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>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>disability</keyword>
  <keyword>EDSS</keyword>
  <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>No</sharing_ipd>
  </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/NCT03302806
org study id: RC16_0232
nct id: NCT03302806
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this observational study is to collect efficacy and safety data in real life
      condition within the first year of treatment in patients with progressive multiple receiving
      a daily dose of biotine of 300 mg.
observational model: Other
time perspective: Prospective
measure: Evolution of post-treatment disability
time frame: 12 months
description: Change in Expanded Disability Status Scale (EDSS) progression from pretreatment period
measure: CGI-t scale
time frame: after 6 months and 12 months
description: Change in Clinical global impression of improvement from both physician and patient assessments
measure: Functional disability : Multiple sclerosis Functional composite
time frame: 12 months
description: Composite score : Change in test measuring the patient's walking speed over a distance of 25 feet(TW25), Symbol Digit Modalities Test (SDMT), 9-Hole Peg Test Scores (9HPT) from baseline
measure: Ambulation
time frame: 12 months
description: Change in MSWS-12 score from baseline
measure: Quality of life
time frame: 12 months
description: Composite score : Change in EQ5D, MusiQuol, TLS coping 10 score from baseline
measure: adverse effect (adverse drug reaction)
time frame: 12 months
description: number of AE
intervention type: Other
intervention name: Non interventional Study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Chronic Progressive
mesh term: Sclerosis
sharing ipd: No