Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial.
Jonathan Kil, Edward Lobarinas, Christopher Spankovich...
https://pubmed.ncbi.nlm.nih.gov/28716314Actively Recruiting
Phase 3
Age: 18Years - 75Years
All Genders
ID06859788
Open-Label Study of SPI-1005 for the Treatment of Meniere's Disease
Led by Sound Pharmaceuticals, Incorporated · Updated on 2026-06-02
200
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of SPI-1005, a glutathione peroxidase mimetic drug, in adults with Meniere's Disease. This open-label Phase 3 study focuses on treatment lasting either 6 or 12 months to support chronic or intermittent use. The study is sponsored by Sound Pharmaceuticals, Incorporated and aims to monitor possible treatment-related adverse events over time. Participants will receive SPI-1005 orally at a dose of 400 mg twice daily. The study does not include a placebo group and all participants will receive the experimental drug openly. The treatment period is either 6 months or 12 months, during which participants will follow the dosing schedule as instructed. During the study, participants will undergo assessments to monitor side effects and safety, including regular check-ins to document any treatment-emergent adverse events at 180 and 360 days. The study includes screening for hearing status and symptoms of Meniere's Disease, and participants will be closely followed throughout the treatment period. Overall participation lasts up to 12 months, with careful observation of safety outcomes.
CONDITIONS
Brief Title
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 360 days
Participants receive oral administration of SPI-1005 400 mg twice daily to treat Meniere's Disease.
Trial Site Locations
Total: 9 locations
1
The House Institute
Los Angeles, California, United States, 90057
Actively Recruiting
2
ENT and Allergy Associates of Florida
Boynton Beach, Florida, United States, 33471
Actively Recruiting
3
ENT and Allergy Associates of Florida
Delray Beach, Florida, United States, 33484
Actively Recruiting
4
Northwell Health
New Hyde Park, New York, United States, 11042
Actively Recruiting
5
ENT and Allergy Associates, LLP
New York, New York, United States, 10017
Actively Recruiting
6
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
7
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
8
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
9
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Ebselen treatment reduces noise induced hearing loss via the mimicry and induction of glutathione peroxidase.
Jonathan Kil, Carol Pierce, Huy Tran...
https://pubmed.ncbi.nlm.nih.gov/17030476Development of ebselen for the treatment of sensorineural hearing loss and tinnitus.
Jonathan Kil, E Emily Harruff, Ryan J Longenecker
https://pubmed.ncbi.nlm.nih.gov/33678494