[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sound Pharmaceuticals, Incorporated\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":41,"locationsCount":44},"100542266","phase-2-spi-1005-in-adults-receiving-cochlear-implant-100542266",false,"NCT06340633","SPI-1005 in Adults Receiving Cochlear Implant","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Adults Receiving a Cochlear Implant","Inclusion Criteria:\n\n* Adults who are ≥18 years of age at time of consent.\n* Post-lingual, bilateral, moderate to profound sensorineural hearing loss scheduled to receive a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.\n* Air conduction thresholds (decibel hearing loss, dB HL) at baseline in the ear scheduled to receive the cochlear implant:\n\n  * ≤70 dB HL at 125, 250, and 500 Hz; AND\n  * ≥70 dB HL at 2000, 4000, and 8000 Hz.\n* Type A (including As and Ad) tympanogram at baseline in the ear scheduled to receive the cochlear implant.\n* Willing and able to provide informed consent and to perform all behavioral tests as specified per-protocol, including pre-specified reproductive requirements.\n\nExclusion Criteria:\n\n* Current, or within 60 days prior to study consent, use of IV 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* Participation in another investigational drug or device study within 90 days prior to study consent.\n* Female patients who are pregnant or breastfeeding.\n* Moderate or severe hepatic impairment using Child-Pugh Score (\\>6 points).\n* No measurable air conduction response at three or more consecutive test frequencies (e.g., 2000, 4000 and 8000 Hz) at baseline in the ear scheduled to receive the cochlear implant.\n* No middle ear mobility (Type B tympanogram) or abnormal middle ear pressure (exceeds -150 to +50 range).","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.\n\nThe main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and\u002For what medical problems might participants experience when taking drug SPI-1005?\n\nThe clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.\n\nParticipants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.\n\nThe effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.",[26,27],"Hearing Loss","Cochlear Trauma",[29,30,31,32],"Hearing Preservation","Cochlear Implant","SPI-1005","Ebselen","RECRUITING","2026-06-23",{"date":36,"type":37},"2026-06-26","ACTUAL",{"date":39,"type":20},"2026-12",{"date":39,"type":20},{"name":42,"class":43},"Sound Pharmaceuticals, Incorporated","INDUSTRY",6,{"id":46,"slug":4,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":72,"locationsCount":73},"100582167","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.","75 Years",{"count":53,"type":20},200,[55],"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.",[58,59],"Meniere's Disease","Ménière's Disease",[61,62,63,64,65,31],"ebselen","hearing loss","tinnitus","vertigo","dizziness","2026-06-01",{"date":68,"type":37},"2026-06-02",{"date":70,"type":37},"2025-10-29",{"date":39,"type":20},{"name":42,"class":43},9,""]