[{"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:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":40,"locationsCount":43},"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":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25,26],"Hearing Loss","Cochlear Trauma",[28,29,30,31],"Hearing Preservation","Cochlear Implant","SPI-1005","Ebselen","RECRUITING","2026-06-23",{"date":35,"type":36},"2026-06-26","ACTUAL",{"date":38,"type":19},"2026-12",{"date":38,"type":19},{"name":41,"class":42},"Sound Pharmaceuticals, Incorporated","INDUSTRY",6,{"id":45,"slug":4,"hasResults":10,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":20,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":71,"locationsCount":72},"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":52,"type":19},200,[54],"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.",[57,58],"Meniere's Disease","Ménière's Disease",[60,61,62,63,64,30],"ebselen","hearing loss","tinnitus","vertigo","dizziness","2026-06-01",{"date":67,"type":36},"2026-06-02",{"date":69,"type":36},"2025-10-29",{"date":38,"type":19},{"name":41,"class":42},9,""]