Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 56
- 主要终点
- Pure Tone Average (PTA)
研究概览
简要总结
The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).
详细描述
This is a Phase III, randomized, double-blind, placebo-controlled, parallel group, multi-center, efficacy and safety trial of AM-111 in the treatment of subjects suffering from severe to profound idiopathic sudden sensorineural hearing loss.
The active pharmaceutical ingredient of AM-111 is a JNK inhibitor (D-JNKI-1), a synthetic peptide consisting of 31 D-amino acids, which acts as a c-Jun N-terminal kinase (JNK) ligand.
The study consists of one treatment visit and a follow-up period until day 91.
Study participants will receive, after topical anesthesia of the tympanic membrane, AM-111 0.4 mg/mL or 0.8 mg/mL or placebo, administered into the affected ear. Following the administration, subjects will rest in a supine or reclined position for 30 minutes. Study participants will have the option for a course of oral corticosteroids.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral idiopathic sudden sensorineural hearing loss (ISSNHL) with onset within 72 hours prior to study treatment;
- •Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across those 3 contiguous air conduction audiometric pure tone frequencies that show the highest mean hearing loss compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a pre-existing audiogram for the affected ear not older than 2 years prior to the ISSNHL incident (defined as "pure tone average", PTA);
- •Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conduction thresholds at the pure tone average frequencies compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a preexisting audiogram for the affected ear not older than 2 years prior to the ISSNHL incident;
- •Age ≥ 18 years on the day of screening;
排除标准
- •Bilateral ISSNHL;
- •Acute hearing loss from noise trauma, barotrauma or head trauma;
- •Air-bone gap greater than 20 dB at the average of 3 contiguous test frequencies below 4 kHz, when the air-bone gap is measurable;
- •History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in either ear;
- •History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
- •Current evidence or history of acoustic neuroma or other retrocochlear damage in the affected ear;
- •History of otosclerosis in the affected ear;
- •Suspected perilymph fistula or membrane rupture in the affected ear;
- •Congenital hearing loss;
- •History of ISSNHL in the past 2 years;
- •Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;
研究组 & 干预措施
Placebo
Placebo gel for intratympanic use
干预措施: Placebo (Other)
AM-111 0.4 mg/ml
AM-111 gel for intratympanic use (0.4 mg/ml AM-111)
干预措施: AM-111 0.4 mg/ml (Drug)
AM-111 0.8 mg/ml
AM-111 gel for intratympanic use (0.8 mg/ml AM-111)
干预措施: AM-111 0.8 mg/ml (Drug)
结局指标
主要结局
Pure Tone Average (PTA)
时间窗: Day 0 and Day 91: The study was prematurely terminated.
Measurement of the recovery of hearing between Day 0 (before treatment) and Day 91, i.e. change in pure tone audiometry between Day 0 and Day 91. The study was prematurely terminated. It was pre-specified not to complete analyses due to premature termination. Not all data planned were collected. No meaningful efficacy analysis could be performed on the data.
次要结局
- Word Recognition Score (WRS) - Main Secondary(Day 0 and Day 91: The study was prematurely terminated.)