A Randomised, Double-Blind, Placebo-Controlled, Clinical Dose-Ranging Trial to Evaluate Efficacy and Safety of a NMDA Antagonist for Oral Administration in Patients With Subjective Tinnitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 431
- 主要终点
- Comparison of adverse events (type, severity, seriousness, frequency, relatedness) between treatment arms
研究概览
简要总结
Tinnitus is commonly referred to as "ringing of the ears" - the perception of sounds in the absence of an external source of acoustic signals. Tinnitus may represent a severe disease and symptoms include depression, sleeping difficulties, decreased sound tolerance and hearing loss. One hypothesis is that tinnitus is caused by an increased activity of NMDA glutamate and dysfunctional alpha9/alpha10 acetylcholine receptors in the inner ear and central nervous system. Neramexane may alleviate tinnitus symptoms due to its NMDA and alpha9/alpha10 nACh receptor blocking activity. The purpose of this study is to assess the safety and efficacy of Neramexane compared with placebo in patients with subjective tinnitus.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •main inclusion criterion: persistent, subjective, uni- or bilateral tinnitus
排除标准
- •main exclusion criterion: intermittent or pulsatile tinnitus
研究组 & 干预措施
Neramexane 25mg/d
干预措施: Neramexane (Drug)
Neramexane 50mg/d
干预措施: Neramexane (Drug)
Neramexane 75mg/d
干预措施: Neramexane (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of adverse events (type, severity, seriousness, frequency, relatedness) between treatment arms
时间窗: From baseline until week 20
Change from baseline in tinnitus severity at the endpoint visit
时间窗: Week 16
次要结局
未报告次要终点