Investigation and Treatment of Ocular Motor Disorders: Cross-over Comparison of Gabapentin and Memantine as Treatment for Nystagmus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percent Change in Median Eye Speed
研究概览
简要总结
Involuntary oscillations of the eyes (nystagmus) impairs vision so that affected patients, who have neurological disorders such as Multiple Sclerosis (MS) , cannot read or watch TV. Two medicines have been reported to suppress nystagmus and improve vision in such patients: gabapentin and memantine. The investigators set out to test which of these two drug was more effective by carrying out a double-blind cross-over study. In this way, we could determine which drug worked best in each patient.
详细描述
The study entails careful measurements of visual acuity and precise measurements of eye movements, using a contact lens device (magnetic search coil method). In this way, it is possible to make objective and reliable measurements of the effect of each drug, which are unbiased by the investigator or the patient.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18 years or older) males or females with acquired nystagmus that is degrading their vision
排除标准
- •Pregnant women
- •Individuals who cannot describe their visual symptoms, cooperate with testing, or give informed consent
- •Individuals with intolerance of gabapentin or memantine
研究组 & 干预措施
Gabapentin
Increasing dose to 300 mg four times per day (total of 1200 mg/day)
干预措施: gabapentin (Drug)
Memantine
Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
干预措施: memantine (Drug)
结局指标
主要结局
Percent Change in Median Eye Speed
时间窗: After 2 weeks of therapy, for both drugs
Median eye speed during attempted visual fixation by each eye
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
时间窗: After 2 weeks of therapy, for both drugs
次要结局
未报告次要终点
研究者
John Leigh
R. John Leigh, M.D.
Case Western Reserve University