A Phase 2b, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 180
- 试验地点
- 10
- 主要终点
- Reduction in the Incidence of a Significant Threshold Shift
研究概览
简要总结
SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.
详细描述
Randomized, double-blind, placebo-controlled, safety and efficacy study of oral SPI-1005 in adults with Noise Induced Hearing Loss (NIHL). All recruited subjects will have their severity of NIHL determined before the start of SPI-1005 treatment using various hearing tests. Subjects will be enrolled and randomized to either placebo or SPI-1005. Subjects will be dosed with either placebo or SPI-1005 for 7 days, beginning 1 day before an acute NIHL. Subjects will have hearing tests performed before and immediately after a calibrated sound challenge (CSC). Follow-up hearing tests will be performed post-CSC.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult male or female patients, 18-50 years of age
- •History of either recreational and/or occupational exposure to noise
- •Voluntarily consent to participate in the study
- •Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or intra-uterine device in place for at least 3 months prior to study through study completion; or barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or stable hormonal contraceptive for at least 3 months prior to study through study completion; or surgical sterilization (vasectomy) of partner at least 6 months prior to study.
- •Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses.
排除标准
- •Current use or within 60 days prior to study of excluded ototoxic medications
- •History of autoimmune inner ear disease
- •History of middle ear or inner ear surgery
- •Current conductive hearing loss or middle ear effusion
- •Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease
- •History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen
- •Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes
- •Participation in another investigational drug or device study within 90 days prior to study enrollment
- •Female patients who are pregnant or breastfeeding
研究组 & 干预措施
SPI-1005 200 mg
200 mg SPI-1005, capsule, bid, po, x7d
干预措施: SPI-1005 200mg (Drug)
SPI-1005 400 mg
400 mg SPI-1005, capsule, bid, po, x7d
干预措施: SPI-1005 400mg (Drug)
Placebo
0 mg SPI-1005, capsule, bid, po, x7d
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in the Incidence of a Significant Threshold Shift
时间窗: Within 1 day
Post Controlled Sound Challenge pure tone audiometry will be compared with baseline
次要结局
- Improvement in word recognition score(Within 1 day)