Open-Label Study of SPI-1005 for the Treatment of Meniere's Disease
Sound Pharmaceuticals, Incorporated
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- 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. * Reproduct…
Interventions
- DrugEbselen
Glutathione peroxidase mimetic
Locations (8)
- The House InstituteLos Angeles, California
- ENT and Allergy Associates of FloridaBoca Raton, Florida
- University of MiamiMiami, Florida
- Northwell HealthNew Hyde Park, New York
- ENT and Allergy Associates, LLPNew York, New York
- Medical University of South CarolinaCharleston, South Carolina