AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1 (AMPACT1) - an Open-Label Extension to the TACTT2 Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction)
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 cycles of AM-101.
详细描述
This open-label extension study is assessing the safety and local tolerance of repeated treatment cycles of AM-101 in subjects previously treated in the scope of the TACTT2 study (NCT01803646).
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 TACTT2 study;
- •Negative pregnancy test (woman of childbearing potential);
- •Willing and able to attend the study visits during at least one treatment cycle.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Adverse event leading to treatment discontinuation in TACTT2;
- •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
AM-101 gel for intratympanic injection
干预措施: AM-101 (Drug)
结局指标
主要结局
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction)
时间窗: Day 84 (TV4) to Day 119 (FUV5) of cycle 2
Valid for Safety Analysis Set was used. Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound. The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction)
时间窗: Day 168 (TV7) up to Day 203 (FUV8) of cycle 3
Valid for Safety Analysis Set was used. Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound. The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction)
时间窗: Day 1 (TV1) to Day 35 (FUV2) of cycle 1
Valid for Safety Analysis Set was used. Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound. The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.
次要结局
- Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction)(Day 1 (TV1) to Day 84 (FUV3) of cycle 1)
- Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction)(Day 84 (TV4) to Day 168 (FUV6) of cycle 2)
- Frequency of Subjects With a Deterioration of Hearing Threshold at Day 252 (Air Conduction)(Day 168 (TV7) to Day 252 (FUV9) of cycle 3)