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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: MD1003 100mg capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis criteria of MS fulfilling revised Mc Donald criteria (2010) Uni-or bilateral optic neuropathy with worst eye VA≤ 5/10 confirmed at 6 months Worsening of visual acuity during the last three years Informed consent prior to any study procedure Patient aged 18-75 years Exclusion Criteria: Optic neuritis relapse within the three months before inclusion Normal RNFL at OCT 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) Bilateral visual acuity <1/20 Visual impairment caused by ocular flutter or nystagmus Pregnancy or childbearing potential woman without contraception Any general chronic handicapping disease other than MS New treatment introduced less than 3 months prior to inclusion or less than 1 month for Fampridine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the best corrected visual acuity at 100% contrast | 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 | 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 | Two parameters will be evaluated: (1) presence of a clear P100 wave, (2) P100 latency | Baseline, 6 months, 12 months | 
| Optical Coherence Tomography | Values of RNFL thickness and macular volume | Baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis (MS), optic neuritis, visual defect, visual loss, relapsing remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (SPMS)