A Phase 2 Double Blind, Randomized, Placebo Controlled Trial inVEstigating the Effect and Safety of Several Dosing Regimens of LY3056480 in Patients With STAble Sensorineural Hearing Loss
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- the efficacy of local treatment with LY3056480 in terms of hearing function
研究概览
简要总结
A phase 2 trial with LY3056480 in patients with stable SNHL
详细描述
VESTA is a double blinded, randomized, placebo controlled, multi center efficacy phase 2 study comparing three dosing regimens of 250 µg LY3056480. Adult volunteers with stable mild to moderately-severe SNHL will be recruited through Adult Otolaryngology - Head & Neck Surgery Services in the US. Four injections of 250µg LY3056480 or placebo administered trans-tympanically into one ear (worse hearing ear).
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
- •Male or female between 18 - 65 years of age;
- •Minimum of six months of documented stable hearing loss (+/- 5dB);
- •A documented stable word recognition test (stable for ~ 6 months +/- 6%/3 words)
排除标准
- •Presenting with a primary complaint of tinnitus
- •Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear
- •History of suspected or diagnosed genetic cause of hearing loss;
- •Partial deafness as defined as hearing loss in any frequency (up to 8 kHz) greater than 80dB
- •Suspected or known diagnosis of the following inner ear pathology, congenital hearing loss, fluctuating hearing loss, Ménière's disease, or secondary endolymphatic hydrops, perilymph fistula, cochlear barotrauma, autoimmune hearing loss, radiation-induced hearing loss, retro-cochlear lesion, ototoxicity
- •Evidence of acute or chronic otitis media or otitis externa on examination; or a history of middle ear pathology and/or surgery (except for ear tubes as a child)
- •Any therapy known as ototoxic
- •Participant in a previous trial of LY3056480
研究组 & 干预措施
Four injections of 250µg LY3056480
The treatment will be given transtympanically over the course of 2-7 weeks, according to dosing regimens below.
- Group 1 - Regimen 1. Day 1, Day 4, Day 8, Day 11
- Group 2 - Regimen 2. Weekly
- Group 3 - Regimen 3. Every two weeks
干预措施: LY3056480 (Drug)
Four injections of placebo
The treatment will be given transtympanically over the course of 2-7 weeks, according to dosing regimens below.
- Group 1 - Regimen 1. Day 1, Day 4, Day 8, Day 11
- Group 2 - Regimen 2. Weekly
- Group 3 - Regimen 3. Every two weeks
干预措施: LY3056480 (Drug)
结局指标
主要结局
the efficacy of local treatment with LY3056480 in terms of hearing function
时间窗: 6 months
• Number of drug responders with at least a 2dB improvement in an adaptive sentence in noise test (international matrix test) compared to placebo
次要结局
未报告次要终点