NCT01757691终止2 期
A 48-week, Double-blind, Randomized, Multi-center, Parallel-group Study Comparing Structural Changes in the Retina and Evolution of Visual Function After Immediate Versus Delayed Treatment With Fingolimod in Patients With Acute Demyelinating Optic Neuritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo
研究概览
简要总结
To evaluate the efficacy and safety of fingolimod 0.5mg versus placebo in patients with suspected acute demyelinating optic neuritis (ADON) receiving standard steroid treatment
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs and symptoms of ADON in one eye (loss of vision, pain on movement, impairment of color vision)
- •First episode of ADON
- •Able to undergo treatment with IV steroids
排除标准
- •History of any unexplained eye or neurological symptoms lasting longer than 48 hours
- •Optic neuritis in both eyes
- •Concomitant condition in either eye, other than optic neuritis
- •History of heart condition/disease
- •Patients with uncontrolled diabetes mellitus
- •Patients with liver conditions/disease
- •Inability to undergo MRI
- •Pregnant or nursing women
- •Women of childbearing potential who are not using highly effective method of birth control
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Fingolimod 0.5mg/daily
Experimental
Oral capsule dose was given once daily for 48 weeks
干预措施: Fingolimod 0.5mg/daily (Drug)
Placebo
Placebo Comparator
Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo
时间窗: Baseline and Week 18
Due to early termination and low patient enrollment the primary outcome measure was not analyzed
次要结局
- Low Contrast Visual Acuity (LCVA)(Baseline, Week 48)
- Vision Based Quality of Life (QoL) Utility Score(Baseline, Week 18, Week 48)
- Proportion of Paatients Converting to Either 2005 or 2010 McDonald MS or to CDMS(Baseline, Week 18, Week 48)
- Number of Particpants With Adverse Events as a Measure of Safety and Tolerability(Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60)
研究者
研究点 (1)
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