Actively Recruiting
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Led by Sound Pharmaceuticals, Incorporated · Updated on 2025-12-26
200
Participants Needed
8
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males or females aged 18 to 75 years at 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) within 3 months before enrollment
- Type A tympanogram at screening
- Air conduction thresholds less than or equal to 90 dB at all tested frequencies (250-8000 Hz) in both ears
- Willing and able to provide informed consent and follow study procedures
- Meets reproductive requirements
You will not qualify if you...
- Use of intravenous or intratympanic ototoxic medications (e.g., chemotherapy drugs or certain antibiotics) within 60 days prior to enrollment
- History of otosclerosis or vestibular schwannoma
- History of significant middle or inner ear surgery in the affected ear
- Conductive hearing loss with air-bone gap 15 dB or more, otitis media, or mixed hearing loss
- Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease
- Use of systemic steroids within 30 days prior to enrollment
- Use of intratympanic steroids within 7 days prior to enrollment
- Hypersensitivity to ebselen or related compounds
- Pregnant or breastfeeding females
- Participation in another investigational drug or device study within 30 days prior to consent
- Residence more than 100 miles from the study site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
The House Institute
Los Angeles, California, United States, 90057
Actively Recruiting
2
ENT and Allergy Associates of Florida
Boca Raton, Florida, United States, 33487
Actively Recruiting
3
University of Miami
Miami, Florida, United States, 33136
Not Yet Recruiting
4
Northwell Health
New Hyde Park, New York, United States, 11042
Actively Recruiting
5
ENT and Allergy Associates, LLP
New York, New York, United States, 10017
Not Yet Recruiting
6
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
7
University of Texas Southwestern
Dallas, Texas, United States, 75390
Not Yet Recruiting
8
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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