NCT00799942终止2 期
Long-term Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Long-term safety, Visual acuity
研究概览
简要总结
The purpose of this study is to investigate the long-term safety, tolerability and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN). In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who has succesfully completed the lead-in study MRZ 92579-0707/1
排除标准
- •Occurence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579-0707/1)
结局指标
主要结局
Long-term safety, Visual acuity
时间窗: Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up
次要结局
未报告次要终点
研究者
研究点 (2)
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