[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100430878":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":25,"responsibleParty":40,"collaborators":25,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":25,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":69,"whyStopped":25,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":25},{"fullName":5,"class":6},"Superficial Siderosis Research Alliance Inc.","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Over-the-Counter Dietary Supplement Inosine","EXPERIMENTAL","capsules containing 500 mg of inosine Two capsules Twice Daily Other Name: hypoxanthine 9-β-D-ribofuranoside 9-\\[(2R,3R,4S,5R)-3,4-dihydroxy-5-hydroxymethyl) oxolan-2-yl\\]-1H-purin-6-one",[13],"Dietary Supplement: Inosine",{"label":15,"type":10,"description":16,"interventionNames":17},"Over-the-Counter Dietary Supplement IP6","capsules containing 500mg of IP6 Two capsules Twice Daily Other Name: Inositol hexaphosphate\n\n(1R,2S,3r,4R,5S,6s)-cyclohexane-1,2,3,4,5,6-hexayl hexakis\\[dihydrogen (phosphate)\\]",[18],"Dietary Supplement: IP6",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Inosine","Patients will be dosed with two 500 mg capsules of Inosine twice daily for 36 months",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"IP6","Patients will be dosed with two 500 mg capsules of IP6 twice daily for 36 months",[15],[31],{"name":32,"affiliation":33,"role":34},"Rori-Suzanne Daniel","Superfical Siderosis Research Alliance","STUDY_DIRECTOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","9035594123","administrator@superficialsiderosis.org",{"type":41,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100430878","therapeutic-antioxidant-supplementation-100430878",false,"NCT04890808","Therapeutic Antioxidant Supplementation","Therapeutic Antioxidant Supplementation for Enhancement of Neural Protection From Free-iron Toxicity in Superficial Siderosis","TAS-SS21","Inclusion Criteria:\n\nConfirmed diagnosis of iSS (superficial siderosis of the CNS)\n\nNo illegal drug use\n\nNo history of myocardial infarction or stroke\n\nNo history of severe chronic obstructive pulmonary disease\n\nCan safely swallow large capsules\n\nExhibits at least one confirmed iSS related symptom: Hearing Loss, Balance, Memory\u002FCognitive problems\n\nDoes not have a known hypersensitivity or intolerance to any study antioxidant\n\nHas not taken part in another treatment study for any condition within the last 30 days (about four and a half weeks)\n\nNot currently pregnant or breastfeeding\n\nExclusion Criteria:\n\nInosine Arm Exclusion :\n\nDiagnosed with urate urolithiasis, or recurrent urolithiasis, all unknown type\n\nHistory of Gout\n\nHistory of Kidney Stones\n\nP6 Arm Exclusion\n\nLong-term anticoagulant\n\nKnown or suspected active bleed into the CNS\n\nCurrently undergoing deferiprone chelation therapy\n\nPlan to begin deferiprone chelation therapy within three years\n\n\\-","ALL","16 Years","77 Years",{"count":54,"type":55},50,"ESTIMATED","INTERVENTIONAL",[58],"NA","A remotely administered study, non-randomized, non-blinded, controlled parallel assignment phase 2 trial to determine if oral inosine or inositol hexaphosphate will provide an effective long-term therapy to combat or slow neural damage progression either concurrently with existing iron chelation therapy or during the natural course of the disorder. Clinical changes in hearing, balance, and mobility, and cognition will be assessed for 36 months through patient-reported outcomes of study assigned assessments.",[61],"Superficial Siderosis",[63,64,65,66,67,68],"Hemosiderin","Iron Toxicity","Superficial siderosis of the CNS","Infratentorial superficial siderosis","Neurodegenerative disorder","Subpial","NOT_YET_RECRUITING","2022-05-04",{"date":72,"type":73},"2022-05-05","ACTUAL",{"date":75,"type":55},"2023-05",{"date":77,"type":55},"2027-09",{"name":5,"class":6}]