Status:
UNKNOWN
Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis
Lead Sponsor:
MedDay Pharmaceuticals SA
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 op...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2018
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT02220244
Start Date
October 1 2013
End Date
January 1 2018
Last Update
March 27 2017
Active Locations (20)
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1
Hopital Pellegrin
Bordeaux, France, 33000
2
Hopital de la cote de Nacre
Caen, France, 14000
3
Hopital Gabriel Montpied
Clermont-Ferrand, France, 63000
4
Hopital general du Bocage
Dijon, France, 21000