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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MedDay Pharmaceuticals SA
ClinicalTrials.gov Identifier:
NCT02220244
First received: August 18, 2014
Last updated: March 23, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Multiple Sclerosis
Drug: MD1003 100mg capsule
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by MedDay Pharmaceuticals SA:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

  • 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

  • Optical Coherence Tomography [ Time Frame: Baseline, 6 months, 12 months ]
    Values of RNFL thickness and macular volume


Estimated Enrollment: 105
Actual Study Start Date: October 2013
Estimated Study Completion Date: January 2018
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02220244

Locations
France
Hopital Pellegrin
Bordeaux, France, 33000
Hopital de la cote de Nacre
Caen, France, 14000
Hopital Gabriel Montpied
Clermont Ferrand, France, 63000
Hopital general du Bocage
Dijon, France, 21000
CHRU de Lille
Lille, France, 59000
Hopital Pierre Wertheimer
Lyon, France, 69000
Hopital de la Timone
Marseille, France, 13000
Hopital Gui de Chauliac
Montpellier, France, 34000
Hopital Central
Nancy, France, 54000
Hopital Nord Laennec
Nantes, France, 44000
Hopital Pasteur
Nice, France, 06000
Centre hospitalier national d'ophtalmologie des Quinze Vingts
Paris, France, 75012
Groupe hospitalier la Pitie-Salpetriere
Paris, France, 75013
Fondation Rothschild
Paris, France, 75019
Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye
Poissy, France, 78300
Hopital Maison Blanche
Reims, France, 51000
Hopital Pontchaillou
Rennes, France, 35000
Hopital de Hautepierre
Strasbourg, France, 67000
Hopital Purpan
Toulouse, France, 31000
United Kingdom
UCL Institute of Neurology
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
MedDay Pharmaceuticals SA
Investigators
Principal Investigator: Ayman Tourbah, MD, PhD Hopital Maison Blanche
Study Director: Frederic Sedel, MD, PhD MedDay Pharmaceuticals SA
  More Information

Additional Information:
Responsible Party: MedDay Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT02220244     History of Changes
Other Study ID Numbers: MD1003CT2013-01MS-ON
2013-002112-27 ( EudraCT Number )
Study First Received: August 18, 2014
Last Updated: March 23, 2017

Keywords provided by MedDay Pharmaceuticals SA:
multiple sclerosis (MS)
optic neuritis
visual defect
visual loss
relapsing remitting multiple sclerosis (RRMS)
primary progressive multiple sclerosis (PPMS)
secondary progressive multiple sclerosis (SPMS)

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Optic Neuritis
Neuritis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on May 25, 2017