[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596029":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":43,"collaborators":26,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":26,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":26,"enrollmentInfo":54,"targetDuration":26,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":26,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Kissei Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"KPS-0373 group","EXPERIMENTAL","* Screening period: One placebo tablet is orally administrated once daily after breakfast for 4 weeks.\n* Treatment period: One KPS-0373 2.4 mg tablet is orally administered once daily after breakfast in 24 weeks.",[13],"Drug: KPS-0373",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","* Screening period: One placebo tablet is orally administrated once daily after breakfast for 4 weeks.\n* Treatment period: One placebo tablet is orally administered once daily after breakfast in 24 weeks.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","KPS-0373","Oral administration",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Placebo",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Kissei Pharmaceutical Co., Ltd Kissei Pharmaceutical Co., Ltd","CONTACT","Email only","rinsyousiken@pharm.kissei.co.jp",[37],{"facility":38,"status":39,"city":40,"state":26,"zip":26,"country":41,"countryCode":42,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"Research Site","RECRUITING","Multiple Locations","Japan","JP",{"type":44,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100596029","phase-3-confirmatory-study-3-of-kps-0373-in-patients-with-spinocerebellar-degeneration-100596029",false,"NCT07040137","Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration","Phase III Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration","Inclusion Criteria:\n\n* Japanese SCD patients with mild to moderate ataxia\n\nExclusion Criteria:\n\n* Patients with secondary ataxia\n* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction","ALL","18 Years",{"count":55,"type":56},142,"ESTIMATED","INTERVENTIONAL",[59],"PHASE3","This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase III study to evaluate the efficacy and safety of KPS-0373 given once daily after breakfast in 142 patients with spinocerebellar degeneration . This study consists of the 4-week screening period, 24-week treatment period, and 4-week follow-up period.",[62],"Spinocerebellar Degeneration","2025-06-25",{"date":65,"type":66},"2025-06-27","ACTUAL",{"date":68,"type":56},"2025-07",{"date":70,"type":56},"2027-03-31",{"name":5,"class":6},1]