SPI-1005 for the Treatment of Meniere's Disease (Open Label)
NCT ID: NCT06859788
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2025-10-29
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open Label
Oral administration of SPI-1005 400 mg BID
Ebselen
Glutathione peroxidase mimetic
Interventions
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Ebselen
Glutathione peroxidase mimetic
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sound Pharmaceuticals, Incorporated
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Facility Contacts
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Study Coordinator
Role: primary
Clinical Research Supervisor
Role: primary
Clinical Research Manager
Role: primary
Research Director
Role: primary
Clinical Research Coordinator
Role: primary
References
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Kil J, Lobarinas E, Spankovich C, Griffiths SK, Antonelli PJ, Lynch ED, Le Prell CG. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2017 Sep 2;390(10098):969-979. doi: 10.1016/S0140-6736(17)31791-9. Epub 2017 Jul 14.
Kil J, Pierce C, Tran H, Gu R, Lynch ED. Ebselen treatment reduces noise induced hearing loss via the mimicry and induction of glutathione peroxidase. Hear Res. 2007 Apr;226(1-2):44-51. doi: 10.1016/j.heares.2006.08.006. Epub 2006 Oct 6.
Kil J, Harruff EE, Longenecker RJ. Development of ebselen for the treatment of sensorineural hearing loss and tinnitus. Hear Res. 2022 Jan;413:108209. doi: 10.1016/j.heares.2021.108209. Epub 2021 Feb 19.
Other Identifiers
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SPI-1005-401
Identifier Type: -
Identifier Source: org_study_id