Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis (MS-ON)

March 23, 2017 updated by: MedDay Pharmaceuticals SA

Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Hôpital Pellegrin
      • Caen, France, 14000
        • Hôpital de la Côte de Nacre
      • Clermont Ferrand, France, 63000
        • Hôpital Gabriel Montpied
      • Dijon, France, 21000
        • Hopital general du Bocage
      • Lille, France, 59000
        • CHRU de Lille
      • Lyon, France, 69000
        • Hôpital Pierre Wertheimer
      • Marseille, France, 13000
        • Hopital de la Timone
      • Montpellier, France, 34000
        • Hopital Gui de Chauliac
      • Nancy, France, 54000
        • Hôpital Central
      • Nantes, France, 44000
        • Hopital Nord Laennec
      • Nice, France, 06000
        • Hopital PASTEUR
      • Paris, France, 75019
        • Fondation Rothschild
      • Paris, France, 75012
        • Centre Hospitalier National D'ophtalmologie Des Quinze Vingts
      • Paris, France, 75013
        • Groupe Hospitalier La Pitie-Salpetriere
      • Poissy, France, 78300
        • Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye
      • Reims, France, 51000
        • Hopital Maison Blanche
      • Rennes, France, 35000
        • Hopital Pontchaillou
      • Strasbourg, France, 67000
        • Hopital de Hautepierre
      • Toulouse, France, 31000
        • Hopital Purpan
  • United Kingdom
      • London, United Kingdom, WC1N 3BG
        • UCL Institute of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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 head abnormalities (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 month for Fampridine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MD1003
MD1003 100mg capsule, 1 capsule TID for 12 months
Drug: MD1003 100mg capsule
Placebo Comparator: Placebo
Placebo capsule, 1 capsule TID for 6 months, then switch to MD1003 100mg capsule, 1 capsule TID for 6 months
Drug: MD1003 100mg capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of the best corrected visual acuity at 100% contrast
Time Frame: Baseline, 6 months
Best corrected visual acuity using the ETDRS logMar chart at 100% contrast
Baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual field mean deviation change from baseline
Time Frame: Baseline, 6 months, 12 months
Visual field analyses are performed using the standard automated perimetry method
Baseline, 6 months, 12 months
Reappearance or improvement of the P00 wave on Visual Evoked Potential
Time Frame: Baseline, 6 months, 12 months
Two parameters will be evaluated: (1) presence of a clear P100 wave, (2) P100 latency
Baseline, 6 months, 12 months
Optical Coherence Tomography
Time Frame: Baseline, 6 months, 12 months
Values of RNFL thickness and macular volume
Baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedDay Pharmaceuticals SA

Investigators

  • Principal Investigator: Ayman Tourbah, MD, PhD, Hopital Maison Blanche
  • Study Director: Frederic Sedel, MD, PhD, MedDay Pharmaceuticals SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD1003CT2013-01MS-ON
  • 2013-002112-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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