Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis

Last updated: March 23, 2017
Sponsor: MedDay Pharmaceuticals SA
Overall Status: Trial Status Unknown

Phase

3

Condition

Scar Tissue

Neurologic Disorders

Multiple Sclerosis

Treatment

N/A

Clinical Study ID

NCT02220244
MD1003CT2013-01MS-ON
2013-002112-27
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis criteria of MS fulfilling revised Mc Donald criteria (2010)

  2. Uni-or bilateral optic neuropathy with worst eye VA≤ 5/10 confirmed at 6 months

  3. Worsening of visual acuity during the last three years

  4. Informed consent prior to any study procedure

  5. Patient aged 18-75 years

Exclusion

Exclusion Criteria:

  1. Optic neuritis relapse within the three months before inclusion

  2. Normal RNFL at OCT

  3. Presence of other ocular pathology (glaucoma, cataract, retinopathy, anterior uveitis,myopia>7 dioptrics, intraocular pressure>20 mm Hg, amblyopia, retinal or optic headabnormalities (drusen, tilted disc)

  4. Bilateral visual acuity <1/20

  5. Visual impairment caused by ocular flutter or nystagmus

  6. Pregnancy or childbearing potential woman without contraception

  7. Any general chronic handicapping disease other than MS

  8. New treatment introduced less than 3 months prior to inclusion or less than 1 monthfor Fampridine

Study Design

Total Participants: 105
Study Start date:
October 01, 2013
Estimated Completion Date:
January 31, 2018

Connect with a study center

  • Hopital Pellegrin

    Bordeaux, 33000
    France

    Site Not Available

  • Hopital de la cote de Nacre

    Caen, 14000
    France

    Site Not Available

  • Hopital Gabriel Montpied

    Clermont Ferrand, 63000
    France

    Site Not Available

  • Hopital general du Bocage

    Dijon, 21000
    France

    Site Not Available

  • CHRU de Lille

    Lille, 59000
    France

    Site Not Available

  • Hopital Pierre Wertheimer

    Lyon, 69000
    France

    Site Not Available

  • Hopital de la Timone

    Marseille, 13000
    France

    Site Not Available

  • Hopital Gui de Chauliac

    Montpellier, 34000
    France

    Site Not Available

  • Hopital Central

    Nancy, 54000
    France

    Site Not Available

  • Hopital Nord Laennec

    Nantes, 44000
    France

    Site Not Available

  • Hopital Pasteur

    Nice, 06000
    France

    Site Not Available

  • Centre hospitalier national d'ophtalmologie des Quinze Vingts

    Paris, 75012
    France

    Site Not Available

  • Fondation Rothschild

    Paris, 75019
    France

    Site Not Available

  • Groupe hospitalier la Pitie-Salpetriere

    Paris, 75013
    France

    Site Not Available

  • Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye

    Poissy, 78300
    France

    Site Not Available

  • Hopital Maison Blanche

    Reims, 51000
    France

    Site Not Available

  • Hopital Pontchaillou

    Rennes, 35000
    France

    Site Not Available

  • Hopital de Hautepierre

    Strasbourg, 67000
    France

    Site Not Available

  • Hopital Purpan

    Toulouse, 31000
    France

    Site Not Available

  • UCL Institute of Neurology

    London, WC1N 3BG
    United Kingdom

    Site Not Available

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