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Hope for Meniere's sufferers: new drug enters final testing phase

NCT ID NCT06859788

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Updated 2 times

Summary

This study tests a drug called SPI-1005 in 200 adults with Meniere's disease, a condition that causes hearing loss, ringing in the ears, and dizziness. Participants will take the drug twice a day for 6 or 12 months to see if it is safe and tolerable. The goal is to find a treatment that can help control the disease over the long term.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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 probable or definite Meniere's Disease by AAO-HNS Amended 2015 Criteria. * At least two of three active symptoms (fluctuating hearing; tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease, within 3 months of study enrollment. * Type A tympanogram at screening. * Air conduction thresholds ≤ 90 dB at all tested frequencies (250-8000 Hz) in both ears. * Subject is willing and able to provide informed consent and perform study procedures and assessments per protocol. * Reproductive requirements Exclusion Criteria: * Current, or within 60 days prior to study enrollment, use of IV or intratympanic ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide. * 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. * Hypersensitivity or idiosyncratic reaction to compounds related to ebselen or excipients. * Female patients who are pregnant or breastfeeding. * Participation in another investigational drug or device study within 30 days prior to study consent. * Participant resides more than 100 miles from the study site.

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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's disease Ménière's disease

Contacts and locations

Locations

  • ENT and Allergy Associates of Florida

    Boynton Beach, Florida, 33471, United States

  • ENT and Allergy Associates of Florida

    Delray Beach, Florida, 33484, United States

  • ENT and Allergy Associates, LLP

    New York, New York, 10017, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Northwell Health

    New Hyde Park, New York, 11042, United States

  • The House Institute

    Los Angeles, California, 90057, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.