Trial | NCT02220244  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    biotin ...

  • Study Participants

    105
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 Started
Oct 31
2013
Primary Completion
Dec 31
2015
Study Completion
Jan 31
2018
Anticipated
Last Update
Mar 27
2017

Drug MD1003 100mg capsule

MD1003 Experimental

MD1003 100mg capsule, 1 capsule TID for 12 months

Placebo Placebo Comparator

Placebo capsule, 1 capsule TID for 6 months, then switch to MD1003 100mg capsule, 1 capsule TID for 6 months

Criteria 

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
No Results Posted