Ebselen for Menière's Disease

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sound Pharmaceuticals, Incorporated

Must not be taking: Ototoxic medications, Systemic steroids

Disqualifiers: Otosclerosis, Significant ear surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-12 months

200 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications before enrolling. Specifically, you must not have used IV or intratympanic ototoxic medications within 60 days, systemic steroids within 30 days, or intratympanic steroids within 7 days prior to joining the study.

Are You a Good Fit for This Trial?

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.

Type A tympanogram at screening

Air conduction thresholds ≤ 90 dB at all tested frequencies (250-8000 Hz) in both ears

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label SPI-1005 400 mg BID for 6 or 12 months

6-12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ebselen

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.

How Is the Trial Designed?

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+