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SPI-1005 for the Treatment of Meniere's Disease (Open Label) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT06859788•Sound Pharmaceuticals, Incorporated

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (8)

The House Institute

Los Angeles, California, United States

ENT and Allergy Associates of Florida

Boca Raton, Florida, United States

University of Miami

Miami, Florida, United States

Northwell Health

New Hyde Park, New York, United States

ENT and Allergy Associates, LLP

New York, New York, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas Southwestern

Dallas, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

October 29, 2025

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

December 26, 2025

Enrollment

200

ESTIMATED participants

Conditions

Meniere's DiseaseMénière's Disease

Interventions

Ebselen

DRUG

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TERMINATEDPHASE4

Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

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TERMINATEDPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A 6-Month Extension Study of OTO-104 in Meniere's Disease

Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

Open Label Study of OTO-104 in Subjects With Meniere's Disease

Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets

OTO-104 for the Treatment of Meniere's Disease

Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease