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
Overview
- Phase
- Phase 3
- Intervention
- Ebselen
- Conditions
- Meniere Disease
- Sponsor
- Sound Pharmaceuticals, Incorporated
- Enrollment
- 254
- Locations
- 12
- Primary Endpoint
- Change in Words-in-Noise Test score
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
SPI-1005 400 mg BID
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Intervention: Ebselen
Placebo
Oral administration of matching placebo BID for 28 days, with 84-day followup
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Words-in-Noise Test score
Time Frame: 56 days
Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test
Incidence of Treatment-Emergent Adverse Events
Time Frame: 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
Time Frame: 56 days
Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
Secondary Outcomes
- 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)