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

NCT06859788 | Recruiting Phase 3 FDA Drug

• 1 other identifier: SPI-1005-401
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Meniere's Disease; Ménière's Disease

Keywords

ebselen; hearing loss; tinnitus; vertigo; dizziness; SPI-1005

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Safety and tolerability assessed based on adverse events

  180 and 360 days

Study Arms (1)

Open Label

EXPERIMENTAL

Oral administration of SPI-1005 400 mg BID

Drug: Ebselen

Interventions

Ebselen DRUG

Glutathione peroxidase mimetic

Also known as: SPI-1005

Open Label

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sound Pharmaceuticals, Incorporated: lead

Study Sites (8)

The House Institute

Los Angeles, California, 90057, United States

RECRUITING

ENT and Allergy Associates of Florida

Boca Raton, Florida, 33487, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

NOT YET RECRUITING

Northwell Health

New Hyde Park, New York, 11042, United States

RECRUITING

ENT and Allergy Associates, LLP

New York, New York, 10017, United States

NOT YET RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75390, United States

NOT YET RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 28716314 BACKGROUND

• 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.

  PMID: 17030476 BACKGROUND

• 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.

  PMID: 33678494 BACKGROUND

MeSH Terms

Conditions

Meniere Disease; Hearing Loss; Tinnitus; Vertigo; Dizziness

Interventions

ebselen

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vestibular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)