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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Incidence of Treatment-Emergent Adverse Events — 180 and 360 days Safety and tolerability assessed based on adverse events
Trial sites (9)
Facility
City
Region
Status
The House Institute
Los Angeles
California
ENT and Allergy Associates of Florida
Boynton Beach
Florida
ENT and Allergy Associates of Florida
Delray Beach
Florida
Northwell Health
New Hyde Park
New York
ENT and Allergy Associates, LLP
New York
New York
Thomas Jefferson University
Philadelphia
Pennsylvania
Medical University of South Carolina
Charleston
South Carolina
University of Texas Southwestern
Dallas
Texas
Medical College of Wisconsin
Milwaukee
Wisconsin
More Sound Pharmaceuticals, Incorporated trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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