Study Title: SPI-1005-401: Open-label study of SPI-1005 for the treatment of Ménière's Disease
The purpose of this study is to find out if an investigational drug called SPI-1005 is safe in people with Meniere’s Disease for 6 or 12 months to support long-term or repeated use. SPI-1005 is an investigational drug. Investigational means the drug is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of your disease.
SPI-1005 is a capsule that contains the investigational drug called ebselen. Ebselen is a new synthetic compound that has been found to reduce inflammation, remove potentially damaging oxidizing agents in the body, and provide protection to inner ear cells against harmful agents. Ebselen mimics the actions of glutathione peroxidase, a naturally occurring enzyme found in the body and the inner ear.
Participants will receive open-label treatment with SPI-1005 400 mg BID for 180 days and up to 360 days. Participants will undergo monthly safety assessments via telehealth and will return to clinic approximately every 90 days after start of treatment for drug supply and safety (including audiometric and vestibular) assessments.
Funded by: Sound Pharmaceuticals, Inc.
Inclusion Criteria
- Adult males and females, age 18-75 years
- Must have diagnosis of probable or definite Meniere’s disease
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Within the past 3 months, you have had at least 2 active symptoms, such as:
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Fluctuating hearing
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Tinnitus (ringing in the ear)
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Ear fullness
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Vertigo or dizziness
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Normal middle ear function (Type A tympanogram).
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Hearing test shows air conduction ≤ 90 dB at tested frequencies (250–8000 Hz) in both ears.
Exclusion Criteria
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Use of IV or intratympanic ototoxic medications within 60 days prior to enrollment (e.g., platinum-based chemotherapy, aminoglycosides, or loop diuretics).
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History of otosclerosis or vestibular schwannoma.
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Significant middle or inner ear surgery in the affected ear.
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Conductive or mixed hearing loss (air-bone gap ≥15 dB) or active otitis media.
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Significant uncontrolled cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease.
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Systemic steroid use within 30 days or intratympanic steroid use within 7 days prior to enrollment.
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Known hypersensitivity to ebselen or its excipients.
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Pregnancy or breastfeeding.
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Participation in another investigational drug or device study within 30 days.
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Residence more than 100 miles from the study site.
If interested, please contact Sean Lang, our Clinical Research Coordinator, at: