What side effects are associated with this type of intervention?

Ebselen, a glutathione peroxidase mimic, has been studied for its antioxidant and anti-inflammatory properties. In clinical trials, it has shown potential in reducing oxidative stress and inflammation without significant adverse systemic or auditory effects. Common treatments for Meniere's Disease, such as diuretics, corticosteroids, and betahistine, may cause side effects like electrolyte imbalance, weight gain, mood changes, and gastrointestinal discomfort. Ebselen's side effect profile appears favorable compared to these traditional treatments, but further research is needed to confirm its long-term safety and efficacy.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs that act as glutathione peroxidase mimics like Ebselen for the treatment of Meniere's Disease. The current FDA-approved treatments for Meniere's Disease primarily focus on symptom management, including diuretics, antihistamines, and corticosteroids to reduce fluid retention and inflammation. Betahistine, although not FDA-approved in the United States, is commonly used in other countries to manage vertigo symptoms associated with Meniere's Disease. The investigational drug SPI-1005 (Ebselen) is being studied for its potential to reduce oxidative stress and inflammation, which could offer a novel therapeutic approach if proven effective.

What other types of research exist?

Promising alternatives to SPI-1005 for Meniere's Disease include idebenone and edaravone. Idebenone, a synthetic analogue of coenzyme Q10, has shown antioxidant properties that protect against noise-induced hearing loss. Edaravone, a free radical scavenger, has demonstrated protective effects against ischemic damage in inner hair cells. Both treatments target oxidative stress and inflammation, making them potential alternatives for Meniere's Disease patients.

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Selenium-containing molecule

SPI-1005 for Meniere's Disease (STOPMD-3 Trial)

Phase 3

Waitlist Available

Research Sponsored by Sound Pharmaceuticals, Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of definite Meniere's Disease by AAO-HNS Amended 2015 Criteria.

Adult males/females, 18-75 years of age at the time of enrollment.

Must not have

Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss.

History of significant middle ear or inner ear surgery in the affected ear.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 84 days

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects for SPI-1005 aren't listed here, common ones may include gastrointestinal discomfort like nausea or diarrhea; allergic reactions; fatigue; and possibly dizziness or headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had major surgery on my middle or inner ear.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 84 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~84 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Words-in-Noise Test score

Change in low frequency hearing thresholds measured by pure tone audiometry

Incidence of Treatment-Emergent Adverse Events

Secondary study objectives

Change in aural fullness

Change in dizziness

Change in tinnitus loudness

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SPI-1005 400 mg BIDExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ebselen

1999

Completed Phase 3

~380

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Meniere's Disease treatments often target the reduction of oxidative stress and inflammation, which are believed to contribute to the symptoms of vertigo, hearing loss, and tinnitus. Ebselen, a glutathione peroxidase mimic, reduces oxidative stress and inflammation by scavenging reactive oxygen species and peroxynitrite, thereby protecting inner ear cells from damage. This mechanism is crucial for Meniere's Disease patients as it addresses the underlying cellular damage that exacerbates their symptoms. Other treatments may include diuretics to reduce fluid buildup in the inner ear, corticosteroids to decrease inflammation, and vestibular rehabilitation to manage balance issues. These approaches collectively aim to alleviate symptoms and improve the quality of life for patients.

A Novel Mouse Model of Aminoglycoside-Induced Hyperacusis and Tinnitus.Ebselen attenuates cisplatin-induced ROS generation through Nrf2 activation in auditory cells.Dose-dependent protection on cisplatin-induced ototoxicity - an electrophysiological study on the effect of three antioxidants in the Sprague-Dawley rat animal model.