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Hearing loss prevention pill put to the test — but study never started

NCT ID NCT02779192

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to test whether an oral drug called SPI-1005 (ebselen) could prevent temporary hearing loss caused by loud noise. Researchers planned to enroll adults aged 18-50 with a history of noise exposure and give them the drug or a placebo for 7 days, then measure hearing changes after a controlled sound challenge. However, the trial was withdrawn before any participants were enrolled, so no data were collected.

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 it works, this could point toward a pill that protects against hearing loss from loud noise.
What could go wrong
The study was withdrawn before enrolling anyone, so no results exist. It is unclear if the drug is effective or safe for this use.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 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 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 male or female patients, 18-50 years of age * History of either recreational and/or occupational exposure to noise * 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 intra-uterine device 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 60 days prior to study of excluded ototoxic medications * History of autoimmune inner ear disease * 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

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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

  • MUSC

    Charleston, South Carolina, 29425, United States

  • Sound Pharmaceuticals, Inc.

    Seattle, Washington, 98103, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66103, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

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