SPI-1005 for the Treatment of Meniere's Disease
- Registration Number
- NCT04677972
- Lead Sponsor
- Sound Pharmaceuticals, Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 254
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral administration of matching placebo BID for 28 days, with 84-day followup SPI-1005 400 mg BID Ebselen Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
- Primary Outcome Measures
Name Time Method Change in Words-in-Noise Test score 56 days Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test
Incidence of Treatment-Emergent Adverse Events 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 56 days Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
- Secondary Outcome Measures
Name Time Method Change in dizziness 56 days Dizziness Handicap Inventory (0-100) where higher score is worse outcome
Change in tinnitus loudness 56 days Tinnitus Functional Index Question #2 -- How Strong or Loud was your Tinnitus? (0-10) where higher score is worse outcome
Change in aural fullness 56 days Aural Fullness Scale (0-10) where higher score is worse outcome
Change in tinnitus severity 56 days Tinnitus Functional Index (0-100) where higher score is worse outcome
Change in vertigo severity 56 days Vertigo Symptom Scale (0-60) where higher score is worse outcome
Trial Locations
- Locations (12)
House Clinic
🇺🇸Los Angeles, California, United States
Sacramento Ear, Nose, & Throat
🇺🇸Roseville, California, United States
ENT and Allergy Associates of Florida
🇺🇸Boca Raton, Florida, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Piedmont Ear, Nose & Throat Associates
🇺🇸Winston-Salem, North Carolina, United States
Advanced ENT & Allergy
🇺🇸Louisville, Kentucky, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States