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Expanded Access Protocol for SPI-1005
Sponsor: Sound Pharmaceuticals, Incorporated
Summary
The purpose of this protocol is to facilitate expanded access ("compassionate use") of SPI-1005 to Meniere's disease (MD) or sudden sensorineural hearing loss (SSNHL) patients who cannot gain access through ongoing clinical trial(s). Adult males and females, age 18 years or older, with Meniere's disease (MD) or sudden sensorineural hearing loss (SSNHL) who have exhausted available standard-of-care therapies and who may receive benefit from SPI-1005 treatment will be selected to participate in the Expanded Access Protocol, subject to Investigator and Sponsor discretion.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
EXPANDED_ACCESS
Enrollment
Not specified
Start Date
Not specified
Completion Date
Not specified
Last Updated
2026-10-14
Healthy Volunteers
Not specified
Conditions
Interventions
Ebselen
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. Neither ebselen nor SPI-1005 have been approved by the FDA to treat any human disease or condition.