Dalfampridine Treatment for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improve visual function
研究概览
简要总结
Determine whether dalfampridine (Ampyra) can improve visual function in patients who have had nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment.
详细描述
The aim of this study is to determine whether dalfampridine can improve visual function in patients who have had nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment.
The objective of this double masked crossover study is to determine whether visual function can be improved in numerous parameters. This includes high contrast visual acuity, low contrast visual acuity, visual field, visual quality of life (VFQ-39), electrophysiology, multi focal electro retinography (mERG), visual evoked potential (VEP), and structure, spectral domain optical coherence tomography (OCT).
Based on the promising results of the use of dalfampridine in Multiple Sclerosis (MS) and in stroke, we hypothesize that the patients with chronic stable deficits after nonarteritic ischemic optic neuropathy (NAION) will have improved visual function with the administration of dalfampridine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NAION 6 months prior to enrollment
- •visual acuity of 20/40 or worse
排除标准
- •Current use of Dalfampridine (Ampyra)
- •Pregnancy
- •History of seizures
- •Renal Failure
- •Not able to perform testing
研究组 & 干预措施
dalfampridine (ampyra)
Dalfampridine (ampyra) 10mgs twice a day (b.i.d.)for two weeks
干预措施: dalfampridine (Drug)
Placebo
placebo (sugar Pill) twice a day (b.i.d.)for two weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Improve visual function
时间窗: two weeks
次要结局
未报告次要终点
研究者
Mark L. Moster, M.d.
Neuro-Ophthalmologist
Neuro-Ophthalmologic Associates, PC