[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542266":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":38,"responsibleParty":133,"collaborators":135,"id":138,"slug":31,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":31,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":31,"enrollmentInfo":146,"targetDuration":31,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":156,"overallStatus":41,"whyStopped":31,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Sound Pharmaceuticals, Incorporated","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SPI-1005 400 mg twice daily (BID)","EXPERIMENTAL","Oral administration of ebselen (SPI-1005) 400 mg BID for 180 days",[13],"Drug: Ebselen",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Oral administration of matching placebo BID for 180 days",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ebselen","Glutathione peroxidase mimetic",[9],[27],"SPI-1005",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Matching placebo containing excipients",[15],null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Jonathan Kil, MD","CONTACT","2066342559","info@soundpharma.com",[39,57,72,87,102,117],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of Iowa","RECRUITING","Iowa City","Iowa","52242","United States",{"type":47,"coordinates":48},"Point",[49,50],-91.53017,41.66113,{"lat":50,"lon":49},[53],{"name":54,"role":35,"phone":55,"phoneExt":31,"email":56},"Lead Clinical Research Coordinator","319-356-8320","kesten-anderson@uiowa.edu",{"facility":58,"status":41,"city":59,"state":60,"zip":61,"country":45,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Ohio State University","Columbus","Ohio","43212",{"type":47,"coordinates":63},[64,65],-82.99879,39.96118,{"lat":65,"lon":64},[68],{"name":69,"role":35,"phone":70,"phoneExt":31,"email":71},"Beth Miles-Markley","614-366-9244","beth.miles-markley@osumc.edu",{"facility":73,"status":41,"city":74,"state":75,"zip":76,"country":45,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Thomas Jefferson University","Philadelphia","Pennsylvania","19107",{"type":47,"coordinates":78},[79,80],-75.16362,39.95238,{"lat":80,"lon":79},[83],{"name":84,"role":35,"phone":85,"phoneExt":31,"email":86},"Morgan Kyser","(215) 955-6760","morgan.kyser@jefferson.edu",{"facility":88,"status":41,"city":89,"state":90,"zip":91,"country":45,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":47,"coordinates":93},[94,95],-79.93275,32.77632,{"lat":95,"lon":94},[98],{"name":99,"role":35,"phone":100,"phoneExt":31,"email":101},"Research Director","(843)792-1356","nguyensh@musc.edu",{"facility":103,"status":41,"city":104,"state":105,"zip":106,"country":45,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"University of Texas Southwestern","Dallas","Texas","75390",{"type":47,"coordinates":108},[109,110],-96.80667,32.78306,{"lat":110,"lon":109},[113],{"name":114,"role":35,"phone":115,"phoneExt":31,"email":116},"Paula Arellano-Cruz","214-648-8096","paula.arellano-cruz@utsouthwestern.edu",{"facility":118,"status":119,"city":120,"state":121,"zip":122,"country":45,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Medical College of Wisconsin","NOT_YET_RECRUITING","Milwaukee","Wisconsin","53226",{"type":47,"coordinates":124},[125,126],-87.90647,43.0389,{"lat":126,"lon":125},[129],{"name":130,"role":35,"phone":131,"phoneExt":31,"email":132},"Clinical Research Coordinator","414.955.0822","smleziva@mcw.edu",{"type":134,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[136],{"name":137,"class":6},"Med-El Corporation","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":147,"type":148},40,"ESTIMATED","INTERVENTIONAL",[151],"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.",[154,155],"Hearing Loss","Cochlear Trauma",[157,158,27,23],"Hearing Preservation","Cochlear Implant","2026-06-23",{"date":161,"type":162},"2026-06-26","ACTUAL",{"date":164,"type":148},"2026-12",{"date":164,"type":148},{"name":5,"class":6},6]