[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542266":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":38,"responsibleParty":134,"collaborators":136,"id":139,"slug":140,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":31,"eligibilityCriteria":145,"healthyVolunteers":141,"sex":146,"minAge":147,"maxAge":31,"enrollmentInfo":148,"targetDuration":31,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":158,"overallStatus":41,"whyStopped":31,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":168,"locationsCount":169},{"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",[39,58,73,88,103,118],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of Iowa","RECRUITING","Iowa City","Iowa","52242","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-91.53017,41.66113,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":56,"phoneExt":31,"email":57},"Lead Clinical Research Coordinator","319-356-8320","kesten-anderson@uiowa.edu",{"facility":59,"status":41,"city":60,"state":61,"zip":62,"country":45,"countryCode":46,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Ohio State University","Columbus","Ohio","43212",{"type":48,"coordinates":64},[65,66],-82.99879,39.96118,{"lat":66,"lon":65},[69],{"name":70,"role":35,"phone":71,"phoneExt":31,"email":72},"Beth Miles-Markley","614-366-9244","beth.miles-markley@osumc.edu",{"facility":74,"status":41,"city":75,"state":76,"zip":77,"country":45,"countryCode":46,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Thomas Jefferson University","Philadelphia","Pennsylvania","19107",{"type":48,"coordinates":79},[80,81],-75.16362,39.95238,{"lat":81,"lon":80},[84],{"name":85,"role":35,"phone":86,"phoneExt":31,"email":87},"Morgan Kyser","(215) 955-6760","morgan.kyser@jefferson.edu",{"facility":89,"status":41,"city":90,"state":91,"zip":92,"country":45,"countryCode":46,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":48,"coordinates":94},[95,96],-79.93275,32.77632,{"lat":96,"lon":95},[99],{"name":100,"role":35,"phone":101,"phoneExt":31,"email":102},"Research Director","(843)792-1356","nguyensh@musc.edu",{"facility":104,"status":41,"city":105,"state":106,"zip":107,"country":45,"countryCode":46,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"University of Texas Southwestern","Dallas","Texas","75390",{"type":48,"coordinates":109},[110,111],-96.80667,32.78306,{"lat":111,"lon":110},[114],{"name":115,"role":35,"phone":116,"phoneExt":31,"email":117},"Paula Arellano-Cruz","214-648-8096","paula.arellano-cruz@utsouthwestern.edu",{"facility":119,"status":120,"city":121,"state":122,"zip":123,"country":45,"countryCode":46,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Medical College of Wisconsin","NOT_YET_RECRUITING","Milwaukee","Wisconsin","53226",{"type":48,"coordinates":125},[126,127],-87.90647,43.0389,{"lat":127,"lon":126},[130],{"name":131,"role":35,"phone":132,"phoneExt":31,"email":133},"Clinical Research Coordinator","414.955.0822","smleziva@mcw.edu",{"type":135,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[137],{"name":138,"class":6},"Med-El Corporation","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":149,"type":150},40,"ESTIMATED","INTERVENTIONAL",[153],"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.",[156,157],"Hearing Loss","Cochlear Trauma",[159,160,27,23],"Hearing Preservation","Cochlear Implant","2026-06-23",{"date":163,"type":164},"2026-06-26","ACTUAL",{"date":166,"type":150},"2026-12",{"date":166,"type":150},{"name":5,"class":6},6]