Effect of MD1003 on visuel impairement of multiple sclerosis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 93

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 two years
4) Informed consent prior to any study procedure
5) Patient aged 18-64 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, amblyopia, retinal or optic head abnormalities (drusen, dysversion)
4)Bilateral visual acuity <1/20
5)Visual impairment caused by ocular flutter or nystagmus
6)Pregnancy or childbearing potential woman without contraception:
-Both male and female subjects who are not either surgically sterile (tubal ligation/obstruction or removal of ovaries or uterus) or post-menopausal (no spontaneous menstrual periods for at least one year confirmed by a negative hormone panel) must commit to using TWO highly effective method of birth control for the duration of the study and for two months after the treatment termination. A highly effective method of birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectable or combined oral contraceptives, IUDs, sexual abstinence or vasectomized partner. Acceptable forms of effective contraception include:
-Established use oral, injected or implanted hormonal methods of contraception.
-Placement of an intrauterine device (IUD) or intrauterine system (IUS).
-Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. Notice that, when used alone, the diaphragm and condom are not highly effective forms of contraception.
-The use of additional spermicides does confer additional theoretical contraceptive protection. Spermicides alone are inefficient at preventing pregnancy when the whole ejaculate is spilled. Therefore, spermicides are not a barrier method of contraception and should not be used alone.
-True abstinence: When this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
-Male sterilisation: subjects must present with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate. For female subjects on the study, the vasectomised male partner should be the sole partner for that subject.
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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