Meniere's Disease, Ménière's Disease
Conditions
Keywords
ebselen, hearing loss, tinnitus, vertigo, dizziness, SPI-1005
Brief summary
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.
Interventions
DRUGEbselen
Glutathione peroxidase mimetic
Sponsors
Sound Pharmaceuticals, Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 180 and 360 days | Safety and tolerability assessed based on adverse events |
Countries
United States
Outcome results
None listed