[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mnires-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mnires-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100582167",false,"NCT06859788","SPI-1005 for the Treatment of Meniere's Disease (Open Label)","Open-Label Study of SPI-1005 for the Treatment of Meniere's Disease","Inclusion Criteria:\n\n* Adult males\u002Ffemales, 18-75 years of age at the time of enrollment.\n* Diagnosis of probable or definite Meniere's Disease by AAO-HNS Amended 2015 Criteria.\n* 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.\n* Type A tympanogram at screening.\n* Air conduction thresholds ≤ 90 dB at all tested frequencies (250-8000 Hz) in both ears.\n* Subject is willing and able to provide informed consent and perform study procedures and assessments per protocol.\n* Reproductive requirements\n\nExclusion Criteria:\n\n* 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.\n* History of otosclerosis or vestibular schwannoma.\n* History of significant middle ear or inner ear surgery in the affected ear.\n* Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss.\n* Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease.\n* Current use or within 30 days prior to study enrollment systemic steroids.\n* Current use or within 7 days prior to study enrollment intratympanic steroids.\n* Hypersensitivity or idiosyncratic reaction to compounds related to ebselen or excipients.\n* Female patients who are pregnant or breastfeeding.\n* Participation in another investigational drug or device study within 30 days prior to study consent.\n* Participant resides more than 100 miles from the study site.","ALL","18 Years","75 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","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.",[26,27],"Meniere's Disease","Ménière's Disease",[29,30,31,32,33,34],"ebselen","hearing loss","tinnitus","vertigo","dizziness","SPI-1005","RECRUITING","2026-06-01",{"date":38,"type":39},"2026-06-02","ACTUAL",{"date":41,"type":39},"2025-10-29",{"date":43,"type":20},"2026-12",{"name":45,"class":46},"Sound Pharmaceuticals, Incorporated","INDUSTRY",9]