Efficacy and Safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Pure tone average (PTA; average of the hearing threshold of three contiguous most affected hearing frequencies in dB)
研究概览
简要总结
The purpose of this research study is to test the effectiveness and safety of the study drug, AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where the cause is unknown.
详细描述
This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of intratympanic AM-111 injections in the treatment of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL). The active pharmaceutical ingredient of AM-111 is the 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.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral ISSNHL with onset within 72 hours prior to study treatment;
- •Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across the 3 most affected contiguous air conduction audiometric pure tone frequencies ("pure tone average", PTA);*
- •Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conducted PTA frequencies compared with the unaffected contralateral ear or reference values from a pre-existing audiogram or ISO 7029;2000 norm values in case of asymmetric hearing prior to the ISSNHL incident;
- •Age ≥ 18 and ≤ 65 years on the day of screening;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Bilateral ISSNHL;
- •Acute hearing loss from noise trauma, barotrauma or head trauma;
- •History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in the affected ear;
- •History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
- •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;
- •Other protocol-defined exclusion criteria may apply.
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; average of the hearing threshold of three contiguous most affected hearing frequencies in dB)
时间窗: Day 28
Assessment with pure tone audiometry/ Measurement at 8 frequencies/ Final outcome is the absolute improvement in PTA from D0 to D28
次要结局
未报告次要终点