NCT06859788进行中（未招募）3 期
Open-Label Study of SPI-1005 for the Treatment of Meniere's Disease
Sound Pharmaceuticals, Incorporated13 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年10月29日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
Study of the safety of open-label SPI-1005 400 mg BID treatment in adults with Meniere's Disease (MD) for 6 or 12 months to support chronic or chronic intermittent use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult males/females, 18-75 years of age at the time of enrollment.
- •Diagnosis of probable or definite Meniere's Disease by AAO-HNS Amended 2015 Criteria.
- •At least two of three active symptoms (fluctuating hearing; tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease, within 3 months of study enrollment.
- •Type A tympanogram at screening.
- •Air conduction thresholds ≤ 90 dB at all tested frequencies (250-8000 Hz) in both ears.
- •Subject is willing and able to provide informed consent and perform study procedures and assessments per protocol.
- •Reproductive requirements
排除标准
- •Current, or within 60 days prior to study enrollment, use of IV or intratympanic ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
- •History of otosclerosis or vestibular schwannoma.
- •History of significant middle ear or inner ear surgery in the affected ear.
- •Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss.
- •Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease.
- •Current use or within 30 days prior to study enrollment systemic steroids.
- •Current use or within 7 days prior to study enrollment intratympanic steroids.
- •Hypersensitivity or idiosyncratic reaction to compounds related to ebselen or excipients.
- •Female patients who are pregnant or breastfeeding.
- •Participation in another investigational drug or device study within 30 days prior to study consent.
- •Participant resides more than 100 miles from the study site.
研究组 & 干预措施
Open Label
Experimental
Oral administration of SPI-1005 400 mg BID
干预措施: Ebselen (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 180 and 360 days
Safety and tolerability assessed based on adverse events
次要结局
未报告次要终点
研究者
研究点 (13)
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