[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476946":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":33,"centralContacts":33,"locations":38,"responsibleParty":264,"collaborators":33,"id":266,"slug":267,"hasResults":268,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":268,"sex":274,"minAge":275,"maxAge":276,"enrollmentInfo":277,"targetDuration":33,"studyType":280,"phases":281,"briefSummary":284,"conditions":285,"keywords":33,"overallStatus":287,"whyStopped":288,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":278},{"fullName":5,"class":6},"Seelos Therapeutics, Inc.","INDUSTRY",[8,14,18,24],{"label":9,"type":10,"description":11,"interventionNames":12},"SLS-005 0.75 g\u002Fkg Dose","EXPERIMENTAL","SLS-005 (trehalose injection, 90.5 mg\u002FmL for intravenous infusion). SLS-005 will be administered as a weight-based dose of 0.75 g\u002Fkg by IV infusion once a week.\n\nFor 52 weeks",[13],"Drug: SLS-005",{"label":15,"type":10,"description":16,"interventionNames":17},"SLS-005 0.50 g\u002Fkg Dose","SLS-005 (trehalose injection, 90.5 mg\u002FmL for intravenous infusion). SLS-005 will be administered as a weight-based dose of 0.50 g\u002Fkg by IV infusion once a week.\n\nFor 52 weeks",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo volume equivalent to a SLS-005 0.75 g\u002Fkg dose calculation","PLACEBO_COMPARATOR","Placebo (sodium chloride injection, 0.9, USP) will be administered by IV infusion once a week as a weight-based volume equivalent to a SLS-005 0.75 g\u002Fkg dose.\n\nFor 52 weeks",[23],"Drug: Placebo",{"label":25,"type":20,"description":26,"interventionNames":27},"Placebo volume equivalent to a SLS-005 0.50 g\u002Fkg dose calculation","Placebo (sodium chloride injection, 0.9, USP) will be administered by IV infusion once a week as a weight-based volume equivalent to a SLS-005 0.50 g\u002Fkg dose.\n\nFor 52 weeks",[23],[29,34],{"type":30,"name":31,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","SLS-005",[15,9],null,{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Placebo","Placebo (sodium chloride injection, 0.9%, USP)",[25,19],[39,52,62,72,82,91,101,111,123,135,145,154,166,175,185,194,203,213,219,225,236,245,254],{"facility":40,"status":33,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":33},"UCLA","Los Angeles","California","90095","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-118.24368,34.05223,{"lat":50,"lon":49},{"facility":53,"status":33,"city":54,"state":55,"zip":56,"country":44,"countryCode":45,"cosmosGeoPoint":57,"geoPoint":61,"contacts":33},"UCHealth Neurosciences Center - Anschutz Medical Campus","Aurora","Colorado","80045",{"type":47,"coordinates":58},[59,60],-104.83192,39.72943,{"lat":60,"lon":59},{"facility":63,"status":33,"city":64,"state":65,"zip":66,"country":44,"countryCode":45,"cosmosGeoPoint":67,"geoPoint":71,"contacts":33},"University of South Florida","Tampa","Florida","33612",{"type":47,"coordinates":68},[69,70],-82.45843,27.94752,{"lat":70,"lon":69},{"facility":73,"status":33,"city":74,"state":75,"zip":76,"country":44,"countryCode":45,"cosmosGeoPoint":77,"geoPoint":81,"contacts":33},"Harvard Medical School - Beth Israel Deaconess Medical Center (BIDMC)","Boston","Massachusetts","02215-5395",{"type":47,"coordinates":78},[79,80],-71.05977,42.35843,{"lat":80,"lon":79},{"facility":83,"status":33,"city":84,"state":84,"zip":85,"country":44,"countryCode":45,"cosmosGeoPoint":86,"geoPoint":90,"contacts":33},"Columbia University Medical Center","New York","10032",{"type":47,"coordinates":87},[88,89],-74.00597,40.71427,{"lat":89,"lon":88},{"facility":92,"status":33,"city":93,"state":94,"zip":95,"country":44,"countryCode":45,"cosmosGeoPoint":96,"geoPoint":100,"contacts":33},"UT Southwestern Medical Center","Dallas","Texas","75390",{"type":47,"coordinates":97},[98,99],-96.80667,32.78306,{"lat":99,"lon":98},{"facility":102,"status":33,"city":103,"state":104,"zip":105,"country":44,"countryCode":45,"cosmosGeoPoint":106,"geoPoint":110,"contacts":33},"Swedish Neuroscience Specialists - Movement Disorders","Seattle","Washington","98122",{"type":47,"coordinates":107},[108,109],-122.33207,47.60621,{"lat":109,"lon":108},{"facility":112,"status":33,"city":113,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":122,"contacts":33},"The Alfred Hospital","Melbourne","Victoria","3004","Australia","AU",{"type":47,"coordinates":119},[120,121],144.96332,-37.814,{"lat":121,"lon":120},{"facility":124,"status":33,"city":125,"state":126,"zip":127,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":134,"contacts":33},"Hospital de Clinicas de Porto Alegre UFRGs","Porto Alegre","Rio Grande do Sul","90035","Brazil","BR",{"type":47,"coordinates":131},[132,133],-51.23019,-30.03283,{"lat":133,"lon":132},{"facility":136,"status":33,"city":137,"state":138,"zip":139,"country":128,"countryCode":129,"cosmosGeoPoint":140,"geoPoint":144,"contacts":33},"Policlinica - Universidade Estadual de Campinas UNICAMP","Campinas","São Paulo","13083",{"type":47,"coordinates":141},[142,143],-47.06083,-22.90556,{"lat":143,"lon":142},{"facility":146,"status":33,"city":147,"state":138,"zip":148,"country":128,"countryCode":129,"cosmosGeoPoint":149,"geoPoint":153,"contacts":33},"University of Sao Paulo","Ribeirão Preto","14049",{"type":47,"coordinates":150},[151,152],-47.81028,-21.1775,{"lat":152,"lon":151},{"facility":155,"status":33,"city":156,"state":157,"zip":158,"country":159,"countryCode":160,"cosmosGeoPoint":161,"geoPoint":165,"contacts":33},"University Hospital of Leipzig","Leipzig","Saxony","04103","Germany","DE",{"type":47,"coordinates":162},[163,164],12.37129,51.33962,{"lat":164,"lon":163},{"facility":167,"status":33,"city":168,"state":33,"zip":169,"country":159,"countryCode":160,"cosmosGeoPoint":170,"geoPoint":174,"contacts":33},"Department of Neurology and Hertie Institute for Clinical Brain Research","Tübingen","72076",{"type":47,"coordinates":171},[172,173],9.05222,48.52266,{"lat":173,"lon":172},{"facility":176,"status":33,"city":177,"state":33,"zip":115,"country":178,"countryCode":179,"cosmosGeoPoint":180,"geoPoint":184,"contacts":33},"Centro Hospitalar e Universitrio de Coimbra","Coimbra","Portugal","PT",{"type":47,"coordinates":181},[182,183],-8.41996,40.20686,{"lat":183,"lon":182},{"facility":186,"status":33,"city":187,"state":33,"zip":188,"country":178,"countryCode":179,"cosmosGeoPoint":189,"geoPoint":193,"contacts":33},"Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Neurologia","Lisbon","1649-028",{"type":47,"coordinates":190},[191,192],-9.1498,38.72509,{"lat":192,"lon":191},{"facility":195,"status":33,"city":196,"state":33,"zip":197,"country":178,"countryCode":179,"cosmosGeoPoint":198,"geoPoint":202,"contacts":33},"Hospital de Santo António, Centro Hospitalar Universitário do Porto","Porto","4099-001",{"type":47,"coordinates":199},[200,201],-8.61097,41.1485,{"lat":201,"lon":200},{"facility":204,"status":33,"city":205,"state":33,"zip":206,"country":207,"countryCode":33,"cosmosGeoPoint":208,"geoPoint":212,"contacts":33},"Seoul National University Hospital","Seoul","03080","South Korea",{"type":47,"coordinates":209},[210,211],126.9784,37.566,{"lat":211,"lon":210},{"facility":214,"status":33,"city":205,"state":33,"zip":215,"country":207,"countryCode":33,"cosmosGeoPoint":216,"geoPoint":218,"contacts":33},"Samsung Medical Center\u002FSungkyunwhan Universtiy School of Medicine","06351",{"type":47,"coordinates":217},[210,211],{"lat":211,"lon":210},{"facility":220,"status":33,"city":205,"state":33,"zip":221,"country":207,"countryCode":33,"cosmosGeoPoint":222,"geoPoint":224,"contacts":33},"Korea University Guro Hospital","08308",{"type":47,"coordinates":223},[210,211],{"lat":211,"lon":210},{"facility":226,"status":33,"city":227,"state":33,"zip":228,"country":229,"countryCode":230,"cosmosGeoPoint":231,"geoPoint":235,"contacts":33},"Hospital Clinic de Barcelona","Barcelona","08036","Spain","ES",{"type":47,"coordinates":232},[233,234],2.15899,41.38879,{"lat":234,"lon":233},{"facility":237,"status":33,"city":238,"state":33,"zip":239,"country":229,"countryCode":230,"cosmosGeoPoint":240,"geoPoint":244,"contacts":33},"Hospital Universitario Ramon y Cajal","Madrid","28034",{"type":47,"coordinates":241},[242,243],-3.70256,40.4165,{"lat":243,"lon":242},{"facility":246,"status":33,"city":247,"state":33,"zip":248,"country":229,"countryCode":230,"cosmosGeoPoint":249,"geoPoint":253,"contacts":33},"Hospital Universitario La Fe","Valencia","46009",{"type":47,"coordinates":250},[251,252],-0.37966,39.47391,{"lat":252,"lon":251},{"facility":255,"status":33,"city":256,"state":33,"zip":33,"country":257,"countryCode":258,"cosmosGeoPoint":259,"geoPoint":263,"contacts":33},"University College London","London","United Kingdom","UK",{"type":47,"coordinates":260},[261,262],-0.12574,51.50853,{"lat":262,"lon":261},{"type":265,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100476946","phase-2-strides---a-clinical-research-study-of-an-investigational-new-drug-to-treat-spinocerebellar-ataxia-100476946",false,"NCT05490563","STRIDES - a Clinical Research Study of an Investigational New Drug to Treat Spinocerebellar Ataxia","A Double-blind, Randomized, Placebo Controlled, Trial to Assess Safety and Efficacy of SLS-005 (Trehalose Injection, 90.5 mg\u002FmL for Intravenous Infusion) for the Treatment of Adults With Spinocerebellar Ataxia","STRIDES","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Men and women, 18 to 75 years (inclusive) of age.\n3. Clinical diagnosis of SCA3 with documented genetic confirmation.\n4. m-SARA total score ≥ 4 at the screening visit.\n5. m-SARA gait component score ≥ 1 at the screening visit.\n6. Body Mass Index (BMI) between 18 kg\u002Fm2 and 35 kg\u002Fm2 (inclusive).\n7. Stable doses of all concomitant medications for at least 30 days prior to the screening visit.\n8. Negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy result at the screening visit for female participants of childbearing potential.\n9. Willingness to comply with sexual abstinence or contraception guidelines of this study.\n\nExclusion Criteria:\n\n1. Any hereditary ataxia that is not genetically confirmed to be SCA type 3, or any type of ataxia that is acquired or secondary to another medical condition including but not limited to, alcoholism, head injury, multiple sclerosis, olivopontocerebellar atrophy, multiple system atrophy, or stroke.\n2. A score of 4 on any 1 of the 4 items that comprise the m-SARA.\n3. Current participation in another clinical trial or completed participation in an interventional trial less than 30 days prior to the screening visit (90 days for a biological treatment).\n4. Current diagnosis and\u002For healthcare professional-recommended treatment (medication and\u002For diet) of diabetes mellitus type 1 or type 2.\n5. Hemoglobin A1c (HbA1c) ≥ 6.5% at the screening visit\n6. Prior treatment with SLS-005, any other IV trehalose formulation, or known hypersensitivity to trehalose.\n7. Pregnant or breastfeeding.\n8. History of alcohol or drug abuse within the last 2 years.\n9. Chronic liver disease including Hepatitis B; Hepatitis C unless successful curative treatment is documented; human immunodeficiency virus (HIV) infection.\n10. Prior history of drug-induced liver injury (DILI) and\u002For laboratory results at screening that indicate inadequate liver function (e.g., alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], gamma-glutamyl transferase \\[GGT\\] \\> 2 times the upper limit of normal \\[x ULN\\] and\u002For total bilirubin level \\> 2 x ULN).\n11. Laboratory results at screening that indicate inadequate renal function (e.g., estimated creatinine clearance of \\\u003C 60 mL\u002Fmin calculated by the Cockcroft and Gault formula).\n12. Any current cardiovascular disease or abnormality on 12-lead ECG at screening that, in the investigator's opinion, is clinically significant and could be a potential safety risk to the participant.\n13. Any current psychiatric, neurological, or cognitive disorder that, in the investigator's opinion, may interfere with the participant's ability to provide informed consent or appropriately complete the study's safety or efficacy assessments.\n14. Significant suicide risk as indicated by a \"yes\" response to question #4 or #5 under Suicidal Ideation in the past 6 months or any \"yes\" response under Suicidal Behavior in the past 3 years on the Columbia Suicide Severity Rating Scale (C-SSRS) during the screening visit.\n15. Any other medical condition or abnormal finding during screening that, in the investigator's opinion, could confound collection or interpretation of safety or efficacy data or be a potential safety risk to the participant","ALL","18 Years","75 Years",{"count":278,"type":279},23,"ACTUAL","INTERVENTIONAL",[282,283],"PHASE2","PHASE3","Phase 2b\u002F3 double blind, randomized, placebo-controlled trial to assess safety and efficacy of SLS-005 (trehalose injection, 90.5 mg\u002FmL for intravenous infusion) for the treatment of adults with spinocerebellar ataxia).",[286],"Spinocerebellar Ataxia Type 3","TERMINATED","This was a business decision due to financial considerations, not based on data related to safety or therapeutic effects.","2024-04-22",{"date":291,"type":279},"2024-04-24",{"date":293,"type":279},"2022-06-03",{"date":295,"type":279},"2023-11-24",{"name":5,"class":6}]