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

Launched by SOUND PHARMACEUTICALS, INCORPORATED · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called SPI-1005, which is being tested for its safety in adults with Meniere's Disease, a condition that affects hearing and balance. The trial will last either 6 or 12 months and aims to find out how well this medication works for people experiencing symptoms like hearing fluctuations, ringing in the ears (tinnitus), a feeling of fullness in the ear, and episodes of dizziness or vertigo.

To be eligible for this study, participants need to be adults aged 18 to 75 who have been diagnosed with Meniere's Disease and currently have at least two active symptoms. It's important that they have not used certain medications or undergone specific ear surgeries recently. If someone joins the trial, they can expect to take the medication twice a day and participate in regular check-ups to monitor their health. This study is not yet recruiting participants, so there will be an opportunity to learn more about it before deciding to take part.

Gender

ALL

Eligibility criteria

• 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.