Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 893
- 试验地点
- 1
- 主要终点
- Efficacy endpoint - alternate primary efficacy endpoints: Patient-reported Tinnitus loudness on a Numerical Rating Scale (TLQ NRS loudest)
研究概览
简要总结
The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months or within the last >3 to 6 months.
详细描述
This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratympanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months (Stratum A), or between >3 and 6 months (Stratum B) from onset).
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
- •Persistent subjective peripheral tinnitus (unilateral or bilateral) following traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer than 3 months (Stratum A) or between >3 months and 6 months (Stratum B) prior to randomization, as documented by medical report or by documented medical history. Upon implementation of protocol amendment 6, subjects with tinnitus following traumatic cochlear injury will only be eligible if they are affected only unilaterally.
- •Age ≥ 18 years and ≤ 75 years;
- •Negative pregnancy test (woman of childbearing potential);
- •Willing and able to use adequate hearing protection, respectively to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured;
- •Willing and able to protect ear canal and middle ear from water exposure as long as tympanic membrane is not fully closed.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Fluctuating tinnitus;
- •Intermittent tinnitus;
- •Tinnitus resulting from traumatic head or neck injury;
- •Presence of chronic tinnitus;
- •Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing loss;
- •History of repeated idiopathic sudden sensorineural hearing loss or history of acoustic neuroma;
- •Ongoing acute or chronic otitis media or otitis externa;
- •Other treatment of tinnitus for the study duration;
- •Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction;
- •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, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months;
- •Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AM-101 injection
AM-101
干预措施: AM-101 (Drug)
Placebo injection
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy endpoint - alternate primary efficacy endpoints: Patient-reported Tinnitus loudness on a Numerical Rating Scale (TLQ NRS loudest)
时间窗: Baseline to Day 84
Improvement in TLQ NRS loudest
Safety endpoint: Hearing threshold
时间窗: Baseline to Day 35
Occurrence of deterioration in hearing threshold \>= 15 decibel (dB) at the average of two contiguous test frequencies (air conduction) in the treated ear(s)
Efficacy endpoint - alternate primary efficacy endpoints: Tinnitus Functional Index (TFI)
时间窗: Baseline to Day 84
Improvement in TFI total score
次要结局
- Safety endpoint - AEs and SAEs(Up to Day 84)
- Efficacy endpoint - Patient global impression of change in tinnitus severity (PGIC Tinnitus)(at Day10, Day 35 and Day 84)
- Efficacy endpoint - TFI(Baseline to Day 10 and Day 35)
- Efficacy endpoint - TLQ NRS loudest(Baseline to Day 10 and Day 35)
- Efficacy endpoint - TFI sleep score(Baseline to Day10, Day 35 and Day 84)
- Efficacy endpoint - patient-reported tinnitus annoyance (TAQ NRS worst)(Baseline to Day10, Day 35 and Day 84)
- Safety endpoint - Hearing threshold(Baseline to Day 1, Day 2, Day 10 and Day 84)