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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02220244
Recruitment Status : Unknown
Verified March 2017 by MedDay Pharmaceuticals SA.
Recruitment status was:  Active, not recruiting
First Posted : August 19, 2014
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
MedDay Pharmaceuticals SA

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: MD1003 100mg capsule Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Actual Study Start Date : October 2013
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : January 2018

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220244


Locations
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Sponsors and Collaborators
MedDay Pharmaceuticals SA
Investigators
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Principal Investigator: Ayman Tourbah, MD, PhD Hopital Maison Blanche
Study Director: Frederic Sedel, MD, PhD MedDay Pharmaceuticals SA
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MedDay Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT02220244    
Other Study ID Numbers: MD1003CT2013-01MS-ON
2013-002112-27 ( EudraCT Number )
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 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:
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Multiple Sclerosis
Neuritis
Optic Neuritis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases