A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 455
- 试验地点
- 74
- 主要终点
- Absolute Change in TBF-12 (Tinnitus Handicap Inventory-12) Total Score from Baseline.
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 75 years with a clinical diagnosis of first onset, persistent (i.e., tinnitus should never be absent for > 24 hours in a row), subjective, uni- or bilateral subacute tinnitus
排除标准
- •Clinical diagnosis of intermittent or pulsatile tinnitus
- •Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Menière's disease, otosclerosis, etc)
研究组 & 干预措施
Neramexane mesylate
Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day
干预措施: Neramexane mesylate (Drug)
Placebo
Placebo: identical placebo tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute Change in TBF-12 (Tinnitus Handicap Inventory-12) Total Score from Baseline.
时间窗: Baseline to week 17 and 29
The TBF-12 is an adapted German version of the original English THI (Tinnitus Handicap Inventory). It is a self-report questionnaire assessing 12 items from 2 dimensions: emotional-cognitive factors and functional-communicational factors. Each item is rated with 0-2 (2= "often"; 1= "sometimes"; 0= "never"). The maximum score is 24 indicating most severe tinnitus impairment. Hierarchical test procedure: Step 1: week 29 in subjects reporting acute hearing loss; step 2: week 17, ditto; step 3: week 29 in total population; step 4: week 17, ditto.
Absolute Change in TSSw (Tinnitus Severity Scale - One Week Version) Total Score from Baseline.
时间窗: Baseline to week 17 and 29
The TSSw is a measure of tinnitus severity. It will be self-evaluated by the patient at various time points on an 11-point Likert-like scale asking for the past week. The scores range from 0 (indicating no tinnitus) to the maximum score of 10 (characterizing the most severe tinnitus considered). Hierarchical test procedure: Step 1: week 29 in subjects reporting acute hearing loss; step 2: week 17, ditto; step 3: week 29 in total population; step 4: week 17, ditto.
次要结局
- TBF-12 Total Score: Change from Baseline(Baseline to week 5, 17, 23, and 29)
- TBF-12 Factorial Scores: Change from Baseline(Baseline to week 5, 17, 23, and 29)
- TBF-12: Individual Responder Rate(Week 5, 17, 23, and 29)
- Tinnitus Rating Scale (one week version): Change from Baseline(Baseline to week 5, 17, 23, and 29)
- Tinnitus Severity Scale (one week version): Change from Baseline(Baseline to week 5, 17, 23, and 29)
- Attention and Performance Self-Assessment (ASPA) Questionnaire: Change from Baseline(Baseline to week 5, 17, 23, and 29)
- Quality of Life Questionnaire (SF-36™ Health Survey): Change from Baseline(Baseline to week 17 and 29)
- Hospital Anxiety and Depression Scale (HADS): Change from Baseline(Baseline to week 17 and 29)