A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 1B Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 15
- 主要终点
- The primary objective of this study is to evaluate the safety and tolerability of two ascending OTO-104 doses relative to placebo. Safety assessments will be performed for 3 months post single intratympanic injection of OTO-104 or placebo.
研究概览
简要总结
The purpose of this study is to evaluate the safety of OTO-104 in subjects with unilateral Meniere's disease. The effectiveness of OTO-104 to reduce the symptoms of Meniere's disease will also be evaluated.
详细描述
Meniere's disease is a debilitating disorder of the inner ear which includes symptoms such as vertigo, tinnitus, hearing loss and aural fullness. Meniere's disease may result from an imbalance of fluid in the inner ear. Several studies have shown that corticosteroids may help manage this imbalance yet the effect does not last very long. OTO-104 is a longer lasting corticosteroid which could provide significant benefit to patients with Meniere's disease.
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
- Triple (Participant, 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
- •Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
- •Subject has experienced active vertigo during the lead-in period.
- •Subject has asymmetric low frequency sensorineural hearing loss.
- •Subject agrees to maintain their current treatments for Meniere's disease while on-study.
- •Subjects not currently on a low-salt diet or diuretic should have a medical history of having used one or both of these treatments for at least 1 month without relief of symptoms.
- •Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study.
排除标准
- •Subject has an infection in the ear, sinuses, or upper respiratory system.
- •Subject is pregnant or lactating.
- •Subject has a history of immunodeficiency disease.
- •Subject has a history of previous endolymphatic sac surgery.
- •Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
- •Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
- •Subject has experienced an adverse reaction to IT injection of steroids.
- •Subject has used an investigational drug or device in the 3 months prior to screening.
- •Subject has had a duration of Meniere's disease of >20 years.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
OTO-104 (steroid) 3 mg
干预措施: OTO-104 (steroid) 3 mg (Drug)
OTO-104 (steroid) 12 mg
The start of 12 mg dose cohort is contingent on safety data from 3 mg dose cohort.
干预措施: OTO-104 (steroid) 12 mg (Drug)
结局指标
主要结局
The primary objective of this study is to evaluate the safety and tolerability of two ascending OTO-104 doses relative to placebo. Safety assessments will be performed for 3 months post single intratympanic injection of OTO-104 or placebo.
时间窗: 3 months
次要结局
- The secondary objective of this study is to evaluate the clinical activity of two OTO-104 doses relative to placebo. Change in baseline for vertigo frequency will be evaluated with descriptive statistics.(3 months)
- The impact of tinnitus on activities of daily living will be measured.(3 months)
- Hearing loss in the affected ear will be measured by audiometric examination.(3 months)
- Quality of life will be measured by patient reported questionnaire.(3 months)
- Severity of vertigo episodes will be measured by the patient reported vertigo score.(3 months)