A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of SPI-1005 in Meniere's Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 18
- 主要终点
- Change in Words-in-Noise Test score
研究概览
简要总结
The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere's disease with active symptoms within three months preceding study enrollment.
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 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 definite Meniere's Disease by AAO-HNS Amended 2015 Criteria.
- •Hearing loss of ≥30 dB at 250, 500, or 1000 Hz at study enrollment.
- •At least two of three active symptoms (tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease by AAO-HNS Amended 2015 Criteria, within 3 months of study enrollment.
排除标准
- •Current, or within 60 days prior to study enrollment, use of IV ototoxic medications
- •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.
研究组 & 干预措施
Placebo
Oral administration of matching placebo BID for 28 days, with 84-day followup
干预措施: Placebo (Drug)
SPI-1005 400 mg BID
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
干预措施: Ebselen (Drug)
结局指标
主要结局
Change in Words-in-Noise Test score
时间窗: 56 days
Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test
Incidence of Treatment-Emergent Adverse Events
时间窗: 84 days
Safety and tolerability assessed based on comparison of adverse events vs. placebo
Change in low frequency hearing thresholds measured by pure tone audiometry
时间窗: 56 days
Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
Change in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry
时间窗: 84 days
Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
Change in Words-in-Noise Test Score
时间窗: 84 days
Co-primary efficacy endpoint; assessment of speech discrimination by Words-in-Noise (WIN) Test (WIN Score Improvement from Baseline \>=4 words) The Words-in-Noise (WIN) test is a speech discrimination test which involves the presentation of specific words against a background noise (multi-talker babble). A total of 35 words are presented to each ear, with 5 words presented at each of 7 different signal-to-noise ratios representing increasing difficulty as the test progresses. The WIN Score is the sum total number of words correct (minimum 0, maximum 35) for each ear. A higher WIN Score is considered to be a better outcome. A WIN Score Improvement is an increase in score from baseline. The co-primary efficacy endpoint is the number of participants who had a WIN Score Improvement from Baseline of \>=4 words out of the maximum of 35 words, in one or both ears.
Number of Participants With Treatment-Emergent Adverse Events
时间窗: 84 days
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
次要结局
- Change in dizziness(56 days)
- Change in tinnitus loudness(56 days)
- Change in aural fullness(56 days)
- Change in tinnitus severity(56 days)
- Change in vertigo severity(56 days)
- Change in Tinnitus Severity(84 days)
- Change in Tinnitus Loudness(84 days)
- Change in Vertigo Severity(84 days)
- Change in Aural Fullness(84 days)
- Change in Dizziness(84 days)