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?

This trial tests a treatment called Ebselen, a new potential drug, to determine its safety for people with Meniere's Disease, which affects hearing and balance. The trial targets individuals with symptoms such as fluctuating hearing, ringing in the ears, or dizziness. Participants should not have used certain medications recently and must live within 100 miles of the study site. Those diagnosed with Meniere's Disease and experiencing these symptoms might find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that Ebselen is likely to be safe for humans?

Research has shown that ebselen, the treatment under study, is safe and well tolerated. In earlier studies, participants taking ebselen experienced few side effects, and most found it acceptable. For instance, research involving individuals with Meniere's Disease and other conditions demonstrated that ebselen was safe for 21 days, with follow-ups confirming its continued safety.

Additionally, other clinical trials have tested ebselen for issues like hearing loss from loud noises, confirming its safety and effectiveness. These trials demonstrate that the treatment has been tested in various situations with consistent safety results. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Menière's Disease?

Unlike the standard treatments for Menière's Disease, which often focus on managing symptoms through diuretics, anti-nausea medications, or surgery, Ebselen offers a new approach by acting as a protective antioxidant. Researchers are excited about Ebselen because it mimics an enzyme in our body that helps reduce oxidative stress, potentially protecting the inner ear from damage. This novel mechanism could not only alleviate symptoms but also slow disease progression, offering hope for a more effective and less invasive treatment option.

What evidence suggests that Ebselen might be an effective treatment for Menière's Disease?

Research has shown that the drug ebselen, specifically in the form of SPI-1005, offers promising results for treating Menière's Disease. One study demonstrated that SPI-1005 improved symptoms by 54.4% compared to a placebo. Other studies have confirmed its effectiveness and safety for this condition and for hearing loss caused by loud noises. This trial will evaluate the effects of SPI-1005 on symptoms like dizziness and hearing problems in people with Menière's Disease. These findings strongly support its potential as a treatment option. ^{2 4 5 6 7}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04677972

SPI-1005 for the Treatment of Meniere's Disease The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult ...

2. 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 ... On day 84, the SPI-1005 group showed a significant rate of WIN improvement of 54.4% over placebo (42.1% vs. 27.1%, p=0.0336). During OLE, ...

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

Development of ebselen for the treatment of sensorineural ... Multiple phase 2 clinical trials have demonstrated the safety and efficacy of SPI-1005 treatment in Meniere's disease and acute noise-induced hearing loss.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06859788

SPI-1005 for the Treatment of Meniere's Disease (Open ... The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose.

5. ovid.com ovid.com/journals/heres/fulltext/10.1016/j.heares.2021.108209~development-of-ebselen-for-the-treatment-of-sensorineural

Development of ebselen for the treatment of... : Hearing ... Multiple phase 2 clinical trials have demonstrated the safety and efficacy of SPI-1005 treatment in Meniere's disease and acute noise-induced hearing loss. SPI- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06859788

SPI-1005 for the Treatment of Meniere's Disease (Open ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... Safety and efficacy of ebselen for the prevention of noise-induced hearing ...

7. soundpharma.com soundpharma.com/wp-content/uploads/2018/11/2018-ARO-151.pdf

SPI-1005 A Novel Investigational Drug For The Treatment ... SPI-1005 was found to be safe and well tolerated following 21 days of dosing in an adult population with. Meniere's Disease, observed and followed for a 7-9 ...