NCT02220244Unknown3 期
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 个研究点 分布在 2 个国家目标入组 105 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 105
- 试验地点
- 20
- 主要终点
- Change from baseline of the best corrected visual acuity at 100% contrast
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MD1003
Experimental
MD1003 100mg capsule, 1 capsule TID for 12 months
干预措施: 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
干预措施: MD1003 100mg capsule (Drug)
结局指标
主要结局
Change from baseline of the best corrected visual acuity at 100% contrast
时间窗: Baseline, 6 months
Best corrected visual acuity using the ETDRS logMar chart at 100% contrast
次要结局
- 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)
研究者
研究点 (20)
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