Multiple Sclerosis
Conditions
Keywords
multiple sclerosis (MS), optic neuritis, visual defect, visual loss, relapsing remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (SPMS)
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.
Interventions
Sponsors
MedDay Pharmaceuticals SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of the best corrected visual acuity at 100% contrast | Baseline, 6 months | Best corrected visual acuity using the ETDRS logMar chart at 100% contrast |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual field mean deviation change from baseline | 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 | Baseline, 6 months, 12 months | Two parameters will be evaluated: (1) presence of a clear P100 wave, (2) P100 latency |
| Optical Coherence Tomography | Baseline, 6 months, 12 months | Values of RNFL thickness and macular volume |
Countries
France, United Kingdom
Outcome results
None listed