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SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss
Sponsor: Sound Pharmaceuticals, Incorporated
Summary
Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.
Official title: Safety and Efficacy Study of SPI-1005 for Prevention of Chemotherapy Induced Hearing Loss
Key Details
Gender
All
Age Range
19 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
0
Start Date
2026-06
Completion Date
2026-06
Last Updated
2026-06-03
Healthy Volunteers
No
Interventions
SPI-1005 Low Dose
Oral capsules, 200 mg ebselen, twice daily, 3 days for each cycle of chemotherapy Arms: Low Dose Other Names: 200 mg Ebselen
SPI-1005 Middle Dose
Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
SPI-1005 High Dose
Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Placebo
Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Locations (1)
VA Puget Sound Health Care
Seattle, Washington, United States