SPI-1005 for the Treatment of Meniere's Disease (Open Label)

July 9, 2026 updated by: Sound Pharmaceuticals, Incorporated

Open-Label Study of SPI-1005 for the Treatment of Meniere's Disease

Study of the safety of open-label SPI-1005 400 mg BID treatment in adults with Meniere's Disease (MD) for 6 or 12 months to support chronic or chronic intermittent use.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90057
        • The House Institute
    • Florida
      • Boynton Beach, Florida, United States, 33471
        • ENT and Allergy Associates of Florida
      • Delray Beach, Florida, United States, 33484
        • ENT and Allergy Associates of Florida
    • New York
      • New Hyde Park, New York, United States, 11042
        • Northwell Health
      • New York, New York, United States, 10017
        • ENT and Allergy Associates, LLP
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open Label
Oral administration of SPI-1005 400 mg BID
Drug: Ebselen
Glutathione peroxidase mimetic
Other Names:
  • SPI-1005

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 180 and 360 days
Safety and tolerability assessed based on adverse events
180 and 360 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sound Pharmaceuticals, Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 5, 2025

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 9, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPI-1005-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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