Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a new drug quiet the ringing and dizziness of Meniere's disease?

NCT ID NCT02603081

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests an experimental drug called SPI-1005 (ebselen) in adults with Meniere's disease, a condition that causes vertigo, tinnitus, and hearing loss. The trial compares three doses of SPI-1005 against a placebo to see if it safely reduces these symptoms. Researchers will monitor side effects, drug levels in the blood, and changes in hearing and balance over several weeks.

What this could mean

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

Active substance
SPI-1005 (ebselen)
What this could lead to
If successful, SPI-1005 could offer a new treatment option to reduce vertigo attacks and hearing loss in people with Meniere's disease.
What could go wrong
This is an early-phase trial with only 40 participants, so results may not apply to everyone. The drug's safety and effectiveness are still unproven.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

40 people

The number who actually took part.

Start date

Dec 2015

Finished

Aug 2017

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

19 to 70 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: * Diagnosis of probable or definite Meniere's Disease by AAO-HNS 1995 criteria within 12 months of study enrollment; * Voluntarily consent to participate in the study; * Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: * Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or * IUD in place for at least 3 months prior to study through study completion; or * Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or * Stable hormonal contraceptive for at least 3 months prior to study through study completion; or * Surgical sterilization (vasectomy) of partner at least 6 months prior to study. * Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses. Exclusion Criteria: * Current use or within 90 days prior to study of ototoxic medications such as aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide); * History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma; * History of middle ear or inner ear surgery; * Current conductive hearing loss or middle ear effusion; * Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease; * History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen; * Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes; * Participation in another investigational drug or device study within 90 days prior to study enrollment; * Female patients who are pregnant or breastfeeding.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Meniere's disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • House Clinic

    Los Angeles, California, 90057, United States

  • MUSC

    Charleston, South Carolina, 29425, United States

  • New York Otology

    New York, New York, 10028, United States

  • Northwest Ear

    Seattle, Washington, 98104, United States

  • Sound Pharmaceuticals, Inc.

    Seattle, Washington, 98103, United States

More trials for these conditions

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