EUCTR2013-002112-27-FR进行中（未招募）1 期
Effect of MD1003 in chronic visual loss related to optic neuritis in multiple sclerosis: a pivotal randomized double masked placebo controlled study - MS-O
MEDDAY SAS0 个研究点目标入组 93 人开始时间: 2015年5月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 93
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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