临床试验/NCT01757691

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

Novartis Pharmaceuticals1 个研究点分布在 1 个国家目标入组 2 人开始时间: 2013年8月最近更新: 2015年5月4日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: Novartis Pharmaceuticals
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

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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

发起方

Novartis Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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