SPI-1005 for Meniere's Disease

(STOPMD-3 Trial)

Recruiting at 24 trial locations

Overseen By Jonathan Kil, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sound Pharmaceuticals, Incorporated

Must not be taking: IV ototoxic, Systemic steroids

Disqualifiers: Otosclerosis, Vestibular schwannoma, others

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: 4 weeks

254 Participants Needed

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?

Ebselen is unique for treating Ménière's disease because it acts as an antioxidant, reducing oxidative stress in the inner ear, which is different from other treatments like the Meniett device or intratympanic steroids that focus on pressure regulation or inflammation reduction. ^{1 2 3 4 5}

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

You have hearing loss of 30 dB or more at 250, 500, or 1000 Hz at study enrollment.

I have had symptoms like ringing in ears, ear fullness, or dizziness due to Meniere's disease recently.

I have been diagnosed with Meniere's Disease according to the AAO-HNS 2015 criteria.

Exclusion Criteria

I have hearing loss that is not solely due to nerve damage.

I have used IV medications that can affect hearing within the last 60 days.

I have used steroids in the past 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either SPI-1005 400 mg BID or placebo for 28 days

4 weeks

Daily oral administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Regular follow-up visits

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

Trial Overview The trial is testing SPI-1005 (Ebselen) against a placebo in adults with active Meniere's Disease symptoms. It's a randomized study where participants don't know if they're getting the real treatment or placebo. After that phase ends, there’s an open-label extension where everyone knows what they’re taking.

How Is the Trial Designed?

Group I: SPI-1005 400 mg BID Experimental Treatment 1 Intervention

Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup

Group II: Placebo Placebo Group 1 Intervention

Oral administration of matching placebo BID for 28 days, with 84-day followup

Who Is Running the Clinical Trial?

Sound Pharmaceuticals, Incorporated

Lead Sponsor

Trials

14

Recruited

1,300+

Published Research Related to This Trial

Meniett therapy has been shown to effectively reduce the frequency of vertigo attacks in patients with Ménière's disease, based on a meta-analysis of 14 studies involving 345 patients.

The therapy may also help alleviate functional deficits associated with the disease, although its impact on hearing remains unclear, and the benefits may last for about 18 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meniett Therapy for Ménière's Disease: An Updated Meta-analysis. Zhang, SL., Leng, Y., Liu, B., et al.[2018]

In a study of 33 patients with unilateral Ménière's disease, 90.9% responded to questionnaires, showing that the Meniett® device significantly alleviated symptoms, with 63.3% reporting reduced vertigo and tinnitus.

The Meniett® device is a well-tolerated and minimally invasive treatment option for Ménière's disease, providing a beneficial alternative before considering more invasive and potentially harmful therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial UK experience of patient satisfaction with the Meniett® device for Ménière's disease treatment. Buchanan, MA., Rai, A., Prinsley, PR.[2019]

Intratympanic steroid treatment may slightly reduce the frequency of vertiginous attacks in patients with Menière's disease, but the evidence is weak and based on very low-quality studies.

No serious adverse events were reported, indicating that the treatment is likely safe; however, further research is necessary to determine its overall efficacy and safety in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intratympanic Steroid for Menière's Disease: A Systematic Review. Devantier, L., Djurhuus, BD., Hougaard, DD., et al.[2020]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Meniett Therapy for Ménière's Disease: An Updated Meta-analysis. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Initial UK experience of patient satisfaction with the Meniett® device for Ménière's disease treatment. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Intratympanic Steroid for Menière's Disease: A Systematic Review. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Hearing results of intratympanic steroid treatment of endolymphatic hydrops. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Endolymphatic sac surgery for Ménière's disease: long-term results after primary and revision surgery. [2008]