EUCTR2016-004544-10-GR进行中（未招募）1 期
A phase I/II multiple ascending dose open-label safety and efficacy study of the Notch Inhibitor LY3056480 in patients with mild to moderate sensorineural hearing loss. - REGAI
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female between 18 and 80 years of age;
- •2. A primary complaint of hearing loss of = 20 years in duration, the history suggesting this hearing-loss to be of age-related, noise-induced or idiopathic origin;
- •3. A bilateral, symmetrical (<15 dBHL difference) SNHL with a pure-tone average threshold across the frequencies 0.5, 1, 2, 4 and 8 kHz of between 25 and 60 dBHL with 2 or more frequencies less than 60 dBHL.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Presenting with a primary complaint of tinnitus;
- •2. A ‘true’ air-bone gap =15 dBHL in 3 or more contiguous frequencies between 0.5, 1, 2, 4 kHz;
- •3. History of suspected or diagnosed genetic cause of hearing loss;
- •4. Suspected or known diagnosis of 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;
- •5. Evidence of acute or chronic otitis media or otitis externa on examination; or a history of middle ear pathology and/or surgery;
- •6. Any therapy known as ototoxic within 12 months of screening.
研究者
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