Ebselen for Menière's Disease

Recruiting at5 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sound Pharmaceuticals, Incorporated

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults with Meniere's Disease, which often causes vertigo. Participants will be taking SPI-1005 twice a day for either 6 or 12 months to see if it helps with their condition over a longer period.

Inclusion Criteria

I have been diagnosed with Meniere's Disease.

I am between 18 and 75 years old.

Type A tympanogram at screening

Exclusion Criteria

Hypersensitivity or idiosyncratic reaction to compounds related to ebselen or excipients

Participation in another investigational drug or device study within 30 days prior to study consent

I have a history of ear bone growth or inner ear tumors.

Treatment Details

Interventions

• Ebselen (Anti-inflammatory)

Trial Overview The trial is testing the safety of an experimental drug called Ebselen (SPI-1005) when taken long-term by people suffering from Meniere's Disease. It aims to understand the effects of daily use for half a year to a full year.

Participant Groups

Group I: Open Label Experimental Treatment 1 Intervention

Oral administration of SPI-1005 400 mg BID

Who Is Running the Clinical Trial?

Sound Pharmaceuticals, Incorporated

Lead Sponsor

Trials

14

Recruited

1,300+