[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596029":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":24,"armGroups":36,"interventions":49,"overallOfficials":24,"centralContacts":58,"locations":64,"responsibleParty":71,"collaborators":24,"id":73,"slug":24,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":24,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":24,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":24,"overallStatus":67,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Kissei Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in SARA total score at 24 weeks of treatment period","The SARA is a scale that assesses cerebellar ataxia. An evaluator observes the subject's ability to perform motor activities across in 8 individual items: (\"gait: 0-8 points,\" \"stance: 0-6 points,\" \"sitting: 0-4 points,\" \"speech disturbance: 0-6 points,\" \"finger chase: 0-4 points,\" \"nose-finger test: 0-4 points,\" \"fast alternating hand movements: 0-4 points,\" and \"heel-shin slide: 0-4 points.\" The total SARA score ranges from 0 (no ataxia) to 40 (severe ataxia).","Up to 24 weeks",[14,16,19,21],{"measure":15,"description":11,"timeFrame":12},"Change from baseline in SARA total score",{"measure":17,"description":18,"timeFrame":12},"Symptom Maintenance Ratio (Ratio of Improvement and Stability Cases) based on SARA total score","Subjects with the change in total SARA score from baseline of ≤ -1 point are defined as improved subjects, subjects with the change in total SARA score of \\> -1 point and \\\u003C 1 point as unchanged subjects, and subjects with improvement and subjects with no change are defined as subjects maintaining symptoms.",{"measure":20,"description":11,"timeFrame":12},"Change from baseline in SARA individual scores",{"measure":22,"description":23,"timeFrame":12},"Change from baseline in SF-8","SF-8 is a questionnaire that comprehensively measures health-related QOL. Subjects answer questions in the following 8 items on a scale of 5 or 6: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. A higher score indicates better health in that item.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":31},"QUADRUPLE",[32,33,34,35],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"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.",[42],"Drug: KPS-0373",{"label":44,"type":45,"description":46,"interventionNames":47},"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.",[48],"Drug: Placebo",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":24},"DRUG","KPS-0373","Oral administration",[38],{"type":51,"name":56,"description":53,"armGroupLabels":57,"otherNames":24},"Placebo",[44],[59],{"name":60,"role":61,"phone":62,"phoneExt":24,"email":63},"Kissei Pharmaceutical Co., Ltd Kissei Pharmaceutical Co., Ltd","CONTACT","Email only","rinsyousiken@pharm.kissei.co.jp",[65],{"facility":66,"status":67,"city":68,"state":24,"zip":24,"country":69,"countryCode":70,"cosmosGeoPoint":24,"geoPoint":24,"contacts":24},"Research Site","RECRUITING","Multiple Locations","Japan","JP",{"type":72,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","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":82,"type":83},142,"ESTIMATED","INTERVENTIONAL",[86],"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.",[89],"Spinocerebellar Degeneration","2025-06-25",{"date":92,"type":93},"2025-06-27","ACTUAL",{"date":95,"type":83},"2025-07",{"date":97,"type":83},"2027-03-31",{"name":5,"class":6},1]