<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/NCT02220933</url>
  </required_header>
  <id_info>
    <org_study_id>MD1003CT2013-02MS-SPI</org_study_id>
    <secondary_id>2013-002113-35</secondary_id>
    <nct_id>NCT02220933</nct_id>
  </id_info>
  <brief_title>Effect of MD1003 in Spinal Progressive Multiple Sclerosis</brief_title>
  <acronym>MS-SPI</acronym>
  <official_title>Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedDay Pharmaceuticals SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedDay Pharmaceuticals SA</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the&#xD;
      disability of patients suffering from progressive multiple sclerosis and especially those&#xD;
      with gait impairment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 2013</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25)</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Proportions of patients in each treatment arm:&#xD;
- with decreased EDSS at M9 confirmed at Month12 (where decreased EDSS is defined as a decrease of at least 0.5 point if initial EDSS from 6 to 7 and a decrease of at least 1 point if initial EDSS from 4.5 to 5.5)&#xD;
or&#xD;
- with improved TW25 of at least 20% at Month 9 and Month12&#xD;
compared to the best EDSS and TW25 scores among screening visit (Month-1) and randomization visit (baseline)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Multiple Sclerosis Walking Scale (MSWS)</measure>
    <time_frame>Baseline, 12 months, 24 months</time_frame>
    <description>The 12-item multiple sclerosis walking scale (MSWS-12) is a self-report measure of the impact of MS on the individual's walking ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression / Subject Global Impression (CGI / SGI)</measure>
    <time_frame>12 months, 24 months</time_frame>
    <description>The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.&#xD;
The clinical global impression will be assessed by the patient (subject global impression, SGI) and by the clinician (clinician global impression, CGI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unidimensional Fatigue Impact Scale (U-FIS)</measure>
    <time_frame>Baseline, 12 months, 24 months</time_frame>
    <description>The U-FIS has 22-items measuring the impact of fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Sclerosis Quality of Life Scale (SEP-59)</measure>
    <time_frame>Baseline, 12 months, 24 months</time_frame>
    <description>The SEP-59 is a multidimensional health-related quality of life measure that combines 36 generic items and 29 MS-specific items into a single instrument.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hole Peg Test (9-HPT)</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months</time_frame>
    <description>The 9-HPT apparatus comprises a container with nine pegs and an empty pegboard with nine holes, set three by three. The pegs must be picked up one at a time and placed in the holes as quickly as possible until all holes are filled. Then, without pausing, the pegs should be removed one at a time, again as quickly as possible. This should be performed twice for each hand. If a peg falls onto the table, the peg should be picked up with the hand which is being tested. If a peg falls onto the floor, it is picked up by the examiner. The time is recorded in seconds, starting as the patient picks up the first peg and ending when the last peg drops into the container.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Brain MRI</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Brain MRI using at least T2 and T1 sequences with gadolinium injection will be performed in a subset of 72 patients i.e 24 in the placebo group and 48 in the treated group, at study onset and after 12 months. Safety of MD1003 will be assessed by comparing novel T2 hypersignals as well as T1 post-gadolinium enhancing lesions in the two groups.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>MD1003</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MD1003 100mg capsules, 1 capsule tid for 24 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsule, 1 capsule tid for 12 months, then switch to MD1003 100mg capsule, 1 capsule tid for 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MD1003 100mg capsule</intervention_name>
    <arm_group_label>MD1003</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis criteria of secondary or primary progressive MS with clinical evidence of&#xD;
             spastic paraparesis fulfilling revised McDonald criteria (2010) and Lublin criteria&#xD;
             (1996)&#xD;
&#xD;
          -  Progression of the EDSS during the past two years of at least 1 point if EDSS from 4.5&#xD;
             to 5.5 and at least 0.5 point if EDSS from 6 to 7&#xD;
&#xD;
          -  EDSS score from 4.5 to 7 (measured away from a relapse and confirmed at 6 months)&#xD;
&#xD;
          -  Informed consent prior to any study procedure&#xD;
&#xD;
          -  Patient aged 18-75 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any general chronic handicapping disease other than MS&#xD;
&#xD;
          -  Intensive physical therapy program within the 3 months prior to inclusion&#xD;
&#xD;
          -  Impossibility to perform the TW25 test&#xD;
&#xD;
          -  New treatment introduced less than 3 months prior to inclusion or less than 1 month&#xD;
             for Fampridine&#xD;
&#xD;
          -  Pregnancy or woman with childbearing potential without contraception&#xD;
&#xD;
          -  Evidence of inflammatory activity of the disease defined as &quot;clinical evidence of a&#xD;
             relapse during the year before inclusion or evidence of new gadolinium-enhanced&#xD;
             lesions on a brain MRI performed the year before inclusion.&quot;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayman Tourbah, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Maison Blanche, Reims, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Frederic Sedel, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Medday SAS, Paris, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la cote de Nacre</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Gabriel Montpied</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital general du Bocage</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Pierre Wertheimer</name>
      <address>
        <city>Lyon</city>
        <zip>69000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Gui de Chauliac</name>
      <address>
        <city>Montpellier</city>
        <zip>34000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Central</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Nord Laennec</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Pasteur</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe hospitalier la Pitié-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondation Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye</name>
      <address>
        <city>Poissy</city>
        <zip>78300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Maison Blanche</name>
      <address>
        <city>Reims</city>
        <zip>51000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Hautepierre</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Purpan</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.medday-pharma.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>March 23, 2017</last_update_submitted>
  <last_update_submitted_qc>March 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>MS</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>
  <pending_results>
    <submitted>November 3, 2020</submitted>
    <returned>November 25, 2020</returned>
  </pending_results>
  <!-- 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/NCT02220933
org study id: MD1003CT2013-02MS-SPI
secondary id: 2013-002113-35
nct id: NCT02220933
lead sponsor: 
has dmc: Yes
The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the
      disability of patients suffering from progressive multiple sclerosis and especially those
      with gait impairment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25)
time frame: up to 24 months
description: Proportions of patients in each treatment arm:
- with decreased EDSS at M9 confirmed at Month12 (where decreased EDSS is defined as a decrease of at least 0.5 point if initial EDSS from 6 to 7 and a decrease of at least 1 point if initial EDSS from 4.5 to 5.5)
or
- with improved TW25 of at least 20% at Month 9 and Month12
compared to the best EDSS and TW25 scores among screening visit (Month-1) and randomization visit (baseline)
measure: Multiple Sclerosis Walking Scale (MSWS)
time frame: Baseline, 12 months, 24 months
description: The 12-item multiple sclerosis walking scale (MSWS-12) is a self-report measure of the impact of MS on the individual's walking ability.
measure: Clinical Global Impression / Subject Global Impression (CGI / SGI)
time frame: 12 months, 24 months
description: The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
The clinical global impression will be assessed by the patient (subject global impression, SGI) and by the clinician (clinician global impression, CGI).
measure: Unidimensional Fatigue Impact Scale (U-FIS)
time frame: Baseline, 12 months, 24 months
description: The U-FIS has 22-items measuring the impact of fatigue.
measure: Multiple Sclerosis Quality of Life Scale (SEP-59)
time frame: Baseline, 12 months, 24 months
description: The SEP-59 is a multidimensional health-related quality of life measure that combines 36 generic items and 29 MS-specific items into a single instrument.
measure: Hole Peg Test (9-HPT)
time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
description: The 9-HPT apparatus comprises a container with nine pegs and an empty pegboard with nine holes, set three by three. The pegs must be picked up one at a time and placed in the holes as quickly as possible until all holes are filled. Then, without pausing, the pegs should be removed one at a time, again as quickly as possible. This should be performed twice for each hand. If a peg falls onto the table, the peg should be picked up with the hand which is being tested. If a peg falls onto the floor, it is picked up by the examiner. The time is recorded in seconds, starting as the patient picks up the first peg and ending when the last peg drops into the container.
measure: Brain MRI
time frame: Baseline, 12 months
description: Brain MRI using at least T2 and T1 sequences with gadolinium injection will be performed in a subset of 72 patients i.e 24 in the placebo group and 48 in the treated group, at study onset and after 12 months. Safety of MD1003 will be assessed by comparing novel T2 hypersignals as well as T1 post-gadolinium enhancing lesions in the two groups.
arm group label: MD1003
arm group type: Experimental
description: MD1003 100mg capsules, 1 capsule tid for 24 months
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsule, 1 capsule tid for 12 months, then switch to MD1003 100mg capsule, 1 capsule tid for 12 months
intervention type: Drug
intervention name: MD1003 100mg capsule
arm group label: MD1003
arm group label: Placebo
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ayman Tourbah, MD, PhD
role: Principal Investigator
affiliation: Hopital Maison Blanche, Reims, France
last name: Frederic Sedel, MD, PhD
role: Study Director
affiliation: Medday SAS, Paris, France
facility: 
facility: 
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country: France
url: http://www.medday-pharma.com
description: Related Info
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Chronic Progressive
mesh term: Sclerosis
submitted: November 3, 2020
returned: November 25, 2020