<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/NCT02220244</url>
  </required_header>
  <id_info>
    <org_study_id>MD1003CT2013-01MS-ON</org_study_id>
    <secondary_id>2013-002112-27</secondary_id>
    <nct_id>NCT02220244</nct_id>
  </id_info>
  <brief_title>Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis</brief_title>
  <acronym>MS-ON</acronym>
  <official_title>Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked 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;
      visual improvement of patients suffering from chronic visual loss resulting from multiple&#xD;
      sclerosis related optic neuritis.&#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">December 2015</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>Change from baseline of the best corrected visual acuity at 100% contrast</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Best corrected visual acuity using the ETDRS logMar chart at 100% contrast</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual field mean deviation change from baseline</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Visual field analyses are performed using the standard automated perimetry method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reappearance or improvement of the P00 wave on Visual Evoked Potential</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Two parameters will be evaluated: (1) presence of a clear P100 wave, (2) P100 latency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical Coherence Tomography</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Values of RNFL thickness and macular volume</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">105</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>MD1003</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MD1003 100mg capsule, 1 capsule TID for 12 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 6 months, then switch to MD1003 100mg capsule, 1 capsule TID for 6 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>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis criteria of MS fulfilling revised Mc Donald criteria (2010)&#xD;
&#xD;
          2. Uni-or bilateral optic neuropathy with worst eye VA≤ 5/10 confirmed at 6 months&#xD;
&#xD;
          3. Worsening of visual acuity during the last three years&#xD;
&#xD;
          4. Informed consent prior to any study procedure&#xD;
&#xD;
          5. Patient aged 18-75 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Optic neuritis relapse within the three months before inclusion&#xD;
&#xD;
          2. Normal RNFL at OCT&#xD;
&#xD;
          3. Presence of other ocular pathology (glaucoma, cataract, retinopathy, anterior uveitis,&#xD;
             myopia&gt;7 dioptrics, intraocular pressure&gt;20 mm Hg, amblyopia, retinal or optic head&#xD;
             abnormalities (drusen, tilted disc)&#xD;
&#xD;
          4. Bilateral visual acuity &lt;1/20&#xD;
&#xD;
          5. Visual impairment caused by ocular flutter or nystagmus&#xD;
&#xD;
          6. Pregnancy or childbearing potential woman without contraception&#xD;
&#xD;
          7. Any general chronic handicapping disease other than MS&#xD;
&#xD;
          8. New treatment introduced less than 3 months prior to inclusion or less than 1 month&#xD;
             for Fampridine&#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</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Frederic Sedel, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>MedDay Pharmaceuticals SA</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>CHRU de Lille</name>
      <address>
        <city>Lille</city>
        <zip>59000</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>Centre hospitalier national d'ophtalmologie des Quinze Vingts</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe hospitalier la Pitie-Salpetriere</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 de 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>
    <facility>
      <name>UCL Institute of Neurology</name>
      <address>
        <city>London</city>
        <zip>WC1N 3BG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://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 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 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 (MS)</keyword>
  <keyword>optic neuritis</keyword>
  <keyword>visual defect</keyword>
  <keyword>visual loss</keyword>
  <keyword>relapsing remitting multiple sclerosis (RRMS)</keyword>
  <keyword>primary progressive multiple sclerosis (PPMS)</keyword>
  <keyword>secondary progressive multiple sclerosis (SPMS)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Neuritis</mesh_term>
    <mesh_term>Optic Neuritis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 29, 2020</submitted>
    <returned>November 20, 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/NCT02220244
org study id: MD1003CT2013-01MS-ON
secondary id: 2013-002112-27
nct id: NCT02220244
lead sponsor: 
has dmc: Yes
The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the
      visual improvement of patients suffering from chronic visual loss resulting from multiple
      sclerosis related optic neuritis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline of the best corrected visual acuity at 100% contrast
time frame: Baseline, 6 months
description: Best corrected visual acuity using the ETDRS logMar chart at 100% contrast
measure: Visual field mean deviation change from baseline
time frame: Baseline, 6 months, 12 months
description: Visual field analyses are performed using the standard automated perimetry method
measure: Reappearance or improvement of the P00 wave on Visual Evoked Potential
time frame: Baseline, 6 months, 12 months
description: Two parameters will be evaluated: (1) presence of a clear P100 wave, (2) P100 latency
measure: Optical Coherence Tomography
time frame: Baseline, 6 months, 12 months
description: Values of RNFL thickness and macular volume
arm group label: MD1003
arm group type: Experimental
description: MD1003 100mg capsule, 1 capsule TID for 12 months
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsule, 1 capsule TID for 6 months, then switch to MD1003 100mg capsule, 1 capsule TID for 6 months
intervention type: Drug
intervention name: MD1003 100mg capsule
arm group label: MD1003
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
last name: Frederic Sedel, MD, PhD
role: Study Director
affiliation: MedDay Pharmaceuticals SA
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country: France
country: United Kingdom
url: http://medday-pharma.com
description: Related Info
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Neuritis
mesh term: Optic Neuritis
mesh term: Sclerosis
submitted: October 29, 2020
returned: November 20, 2020