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Could this pill ease Meniere's hearing loss and dizziness?

NCT ID NCT04677972

Disease control Sponsor: Sound Pharmaceuticals, Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tested an experimental drug called SPI-1005 (ebselen) in 254 adults with Meniere's disease, a condition causing hearing loss, ringing in the ears, and dizziness. Participants received either the drug or a placebo for a set period, followed by an open-label phase where everyone could get the drug. The goal was to see if SPI-1005 safely improves hearing and reduces symptoms like tinnitus and vertigo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ebselen (SPI-1005)
What this could lead to
If successful, this could lead to a new treatment option for Meniere's disease that helps protect hearing and reduce tinnitus and vertigo symptoms.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not prove better than placebo, and side effects are possible. It is not a cure, and patients may still need ongoing management.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

220 people

The number who actually took part.

Started

Aug 2022

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult males/females, 18-75 years of age at the time of enrollment. * Diagnosis of definite Meniere's Disease by AAO-HNS Amended 2015 Criteria. * Hearing loss of ≥30 dB at 250, 500, or 1000 Hz at study enrollment. * At least two of three active symptoms (tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease by AAO-HNS Amended 2015 Criteria, within 3 months of study enrollment. Exclusion Criteria: * Current, or within 60 days prior to study enrollment, use of IV ototoxic medications * History of otosclerosis or vestibular schwannoma. * History of significant middle ear or inner ear surgery in the affected ear. * Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss. * Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease. * Current use or within 30 days prior to study enrollment systemic steroids. * Current use or within 7 days prior to study enrollment intratympanic steroids.

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Conditions

The condition(s) this trial relates to.

Dizziness hearing loss disorder Meniere disease Tinnitus Vertigo

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Meniere disease Ménière

Contacts and locations

Locations

  • Advanced ENT & Allergy

    Louisville, Kentucky, 40207, United States

  • ENT and Allergy Associates of Florida

    Boca Raton, Florida, 33487, United States

  • George Washington University

    Washington D.C., District of Columbia, 20037, United States

  • House Clinic

    Los Angeles, California, 90057, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Kansas University Medical Center

    Kansas City, Kansas, 66160, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Piedmont Ear, Nose & Throat Associates

    Winston-Salem, North Carolina, 27103, United States

  • Sacramento Ear, Nose, & Throat

    Roseville, California, 95661, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19144, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

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