NCT02220244UnknownPhase 3
Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study
MedDay Pharmaceuticals SA20 sites in 2 countries105 target enrollmentStarted: October 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 105
- Locations
- 20
- Primary Endpoint
- Change from baseline of the best corrected visual acuity at 100% contrast
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
MD1003
Experimental
MD1003 100mg capsule, 1 capsule TID for 12 months
Intervention: MD1003 100mg capsule (Drug)
Placebo
Placebo Comparator
Placebo capsule, 1 capsule TID for 6 months, then switch to MD1003 100mg capsule, 1 capsule TID for 6 months
Intervention: MD1003 100mg capsule (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Visual field mean deviation change from baseline(Baseline, 6 months, 12 months)
- Reappearance or improvement of the P00 wave on Visual Evoked Potential(Baseline, 6 months, 12 months)
- Optical Coherence Tomography(Baseline, 6 months, 12 months)
Investigators
Study Sites (20)
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