NCT02040207已完成3 期
AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 2 (AMPACT2) - an Open-Label Extension to the TACTT3 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 487
- 试验地点
- 1
- 主要终点
- Hearing threshold
研究概览
简要总结
The purpose of this research study is to test the safety and local tolerance of repeated treatment with AM-101.
详细描述
This open-label extension study is assessing the safety and local tolerance of repeated treatment with AM-101 in subjects previously treated in the scope of the TACTT3 study.
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 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of TACTT3 study;
- •Negative pregnancy test (woman of childbearing potential);
- •Willing and able to attend the study visits.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Adverse event leading to treatment discontinuation in TACTT3;
- •Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating hearing loss, otitis media, otitis externa, abnormality of tympanic membrane;
- •Ongoing drug-based therapy for otitis media or otitis externa;
- •Drug-based therapy known as potentially tinnitus-inducing;
- •Other treatment of tinnitus;
- •Drug abuse or alcoholism;
- •Subjects with psychiatric diseases requiring drug treatment;
- •Use of antidepressant or anti-anxiety medication;
- •Any clinically relevant disorder or abnormality in physical examination;
- •Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
- •Women of childbearing potential who are unwilling or unable to practice contraception.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AM-101 injection
Experimental
AM-101 gel for intratympanic injection
干预措施: AM-101 (Drug)
结局指标
主要结局
Hearing threshold
时间窗: Up to Day 203
Occurrence of deterioration in hearing threshold in the treated ear(s)
次要结局
- Hearing threshold(Up to Day 252)
- Adverse events and serious adverse events(Up to Day 252)
研究者
研究点 (1)
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