[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100357534":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":46,"locations":55,"responsibleParty":76,"collaborators":33,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":33,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":33,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":57,"whyStopped":33,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Botulinum Toxin","EXPERIMENTAL","The investigators plan to administer approximately 1000 U Dysport ® in the concave-sided paraspinal musculature of the major curve, based on an estimated total dose of 1000 U, the maximum allowable dose. The total dose per treatment session will not exceed 15 units\u002Fkilogram or 1000 units, whichever is lower. If two curves are equivalent within 3˚, both will be treated, however, the dosing (described above) will be divided equally across both curves.\n\nThere will be two cycles of injections. Patients will be treated at time 0 (baseline) and 4 months.",[13,14],"Drug: AbobotulinumtoxinA","Device: Custom Thoracolumbosacral Orthosis",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo","PLACEBO_COMPARATOR","Control patients will receive an injection of placebo specifically prepared as a control for this study. The same volumes as indicated in the \"experimental\" arm description will be injected.\n\nThese will be administered during two cycles of injections. Patients will be treated at time 0 (baseline) and 4 months.",[20,14],"Drug: Placebos",[22,29,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","AbobotulinumtoxinA","Paraspinal abobotulinumtoxinA injections (compared to placebo)",[9],[28],"Dysport, Ipsen",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Placebos","Placebo prepared by Ipsen for use as control",[16],null,{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":33},"DEVICE","Custom Thoracolumbosacral Orthosis","Non-operative external bracing for scoliosis curves",[9,16],[40,44],{"name":41,"affiliation":42,"role":43},"Paul Sponseller, MD, MBA","Johns Hopkins Hospital Department of Orthopaedic Surgery","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":42,"role":43},"Varun Puvanesarajah, MD",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":33,"email":51},"Gabrielle Reichard, MA","CONTACT","4105023626","greicha1@jhmi.edu",{"name":45,"role":49,"phone":53,"phoneExt":33,"email":54},"9193605646","vpuvane1@jhmi.edu",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Baltimore","Maryland","21287","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-76.61219,39.29038,{"lat":67,"lon":66},[70,72,74],{"name":45,"role":49,"phone":71,"phoneExt":33,"email":54},"410-955-3136",{"name":48,"role":49,"phone":50,"phoneExt":33,"email":73},"greicha1@jh.edu",{"name":75,"role":43,"phone":33,"phoneExt":33,"email":33},"Paul D Sponseller, MD",{"type":77,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100357534","phase-4-dysport--as-an-adjunctive-treatment-to-bracing-in-the-management-of-adolescent-idiopathic-scoliosis-100357534",false,"NCT03935295","Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis","Dysport ® (abobotulinumtoxinA) as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis","Inclusion criteria:\n\n* Clinically determined idiopathic nature of scoliosis\n* Age 10-16 years\n* Risser stage 0,1,or 2\n* major curve of 20°-40°\n* curve apex caudal to T7 vertebra\n* ability to adhere to bracing protocol\n* Botulinum toxin naïve or previously treated greater than 6 months prior to study entry\n\nExclusion criteria:\n\n* Diagnosis of congenital scoliosis, neuromuscular scoliosis, or other \"reason\" for scoliosis - Previous surgery at any segment of the spine\n* Current need for surgery at any level of the spine\n* Treatment with any drug known to interfere with neuromuscular function\n* Any other medical condition, laboratory or diagnostic procedure finding that might preclude administration of BTX\n* Ongoing infection at the injection sites\n* Diagnosis as either resistant or sensitive to botulinum toxin treatment of any type or to any components of the BTX formulation\n* Cow milk protein allergy","ALL","10 Years","16 Years",{"count":89,"type":90},90,"ESTIMATED","INTERVENTIONAL",[93],"PHASE4","This study evaluates the combined effect of botulinum toxin A (administered as Dysport® (Ipsen Pharmaceuticals)) and bracing in children with adolescent idiopathic scoliosis. Two thirds of patients will be treated with Dysport® and bracing, while the remaining patients will be treated with placebo and bracing.",[96],"Adolescent Idiopathic Scoliosis",[98,99],"AIS","adolescent idiopathic scoliosis","2025-12-05",{"date":102,"type":103},"2025-12-09","ACTUAL",{"date":105,"type":103},"2020-09-03",{"date":107,"type":90},"2026-12-31",{"name":5,"class":6},1]