SPI-1005 for Meniere's Disease

(STOPMD-3 Trial)

No longer recruiting at 25 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Ebselen for individuals with Meniere's disease, a condition affecting the inner ear that can cause vertigo, tinnitus (ringing in the ears), and hearing loss. The study aims to determine if Ebselen can reduce these symptoms compared to a placebo (a pill with no active medicine). Participants will take either the treatment or placebo for 28 days, followed by an 84-day follow-up. Adults who have recently experienced symptoms like ringing in the ears, ear fullness, or dizziness due to Meniere's and have certain levels of hearing loss might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially bringing a new treatment to market.

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.

Is there any evidence suggesting that SPI-1005 is likely to be safe for humans?

Research has shown that SPI-1005, containing the substance ebselen, has been tested in several studies and found to be safe for humans. Participants in these studies generally tolerated the treatment well. Ebselen did not cause serious side effects, suggesting it is likely safe for individuals with Meniere’s disease. However, safety in one study does not guarantee safety for everyone. Nonetheless, the results for SPI-1005 appear promising so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Meniere's disease?

Unlike the standard treatments for Meniere's Disease, which often include diuretics, anti-nausea medications, or even surgery to manage symptoms, SPI-1005 uses ebselen, a novel compound that mimics the activity of a natural enzyme in the ear. This enzyme, glutathione peroxidase, helps reduce oxidative stress and inflammation, which are thought to contribute to the symptoms of Meniere's Disease. Researchers are excited about SPI-1005 because it targets the underlying causes of the condition rather than just alleviating symptoms, offering a potential new approach to treatment. Additionally, ebselen has shown promise in other conditions related to oxidative stress, further fueling optimism about its potential efficacy for Meniere's Disease.

What evidence suggests that SPI-1005 might be an effective treatment for Meniere's disease?

Research has shown that SPI-1005, containing a substance called ebselen, may help treat Meniere's disease. In this trial, participants will receive either SPI-1005 or a placebo. Studies have found that SPI-1005 can greatly improve hearing and speech understanding in people with this condition. Earlier trials demonstrated its safety and effectiveness, with patients noticing clear improvements. Ebselen protects cells in the ear, potentially reducing the symptoms of Meniere's disease. These findings offer hope to those facing the challenges of this condition. ^{1 2 4 5 6}

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

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]

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]

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.

soundpharma.com

soundpharma.com/sound-pharma-announces-positive-phase-3-results-for-the-treatment-of-menieres-disease-with-spi-1005/

Sound Pharma Announces Positive Phase 3 Results for ...

SPI-1005 is an oral capsule containing 200 mg ebselen that has shown safety and efficacy in several Phase 2 clinical trials involving multiple ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04677972

SPI-1005 for the Treatment of Meniere's Disease

Study Overview​​ The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI- ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06859788

SPI-1005 for the Treatment of Meniere's Disease (Open ...

Study Overview​​ 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 ...

4.

pharmacytimes.com

pharmacytimes.com/view/phase-3-data-offer-hope-to-patients-with-meniere-disease

Phase 3 Data Offer Hope to Patients With Meniere Disease

SPI-1005 demonstrated significant efficacy in improving hearing loss and speech discrimination in Meniere disease patients during a phase 3 ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0378595521000435

Development of ebselen for the treatment of sensorineural ...

Ebselen is the first investigational new drug to advance to Phase 3 in Meniere's Disease. · Ebselen was shown to be effective in a Phase 2 involving Noise- ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06859788

SPI-1005 for the Treatment of Meniere's Disease (Open ...

Study Overview​​ 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 ...