SPI-1005 for Meniere's Disease
(STOPMD-3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing SPI-1005, a medication for adults with Meniere's disease who have had recent symptoms. The medication aims to help by balancing inner ear fluids or reducing inflammation. SPI-1005, also known as ebselen, has shown promise in reducing hearing loss in animals and has demonstrated safety in previous studies for Meniere's disease and acute noise-induced hearing loss.
Will I have to stop taking my current medications?
The trial requires that you stop using certain medications before enrolling. You must not have used IV ototoxic medications within 60 days, systemic steroids within 30 days, or intratympanic steroids within 7 days before joining the study.
How is the drug Ebselen unique for treating Ménière's disease?
Are You a Good Fit for This Trial?
Adults aged 18-75 with definite Meniere's Disease, experiencing tinnitus, aural fullness, or vertigo recently. They must have hearing loss at certain frequencies. Excluded are those with recent ototoxic meds use, conductive hearing issues, major health problems in various organs, steroid treatments close to enrollment, and past significant ear surgeries.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either SPI-1005 400 mg BID or placebo for 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may opt into continuation of treatment long-term to evaluate chronic safety
What Are the Treatments Tested in This Trial?
Interventions
- Ebselen
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sound Pharmaceuticals, Incorporated
Lead Sponsor