[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520029":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":42,"responsibleParty":78,"collaborators":80,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":31,"enrollmentInfo":93,"targetDuration":31,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":108,"overallStatus":63,"whyStopped":31,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Region Stockholm","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lithium","EXPERIMENTAL","Lithionit 42 mg (lithium sulphate, 6 mmol), start dose 1x1, then slow dose escalation using therapeutic drug monitoring (TDI) to establish a target serum level of 0.5-1.0 mmol\u002Fliter.",[13],"Drug: Lithium",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Identical looking placebo (white round tablet, 10 mm diameter) will be dose escalated and monitored the same way as lithium, with sham values guiding the dosing.",[19],"Drug: Placebo",[21,28],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Lithium sulphate, 42 mg (6 mmol lithium)",[9],[26,27],"Lithionit","Lithium sulphate",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"White round tablet, 10 mm. Identical to experimental drug (lithium)",[15],null,[33,38],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Klas Blomgren, MD, Professor","CONTACT","0046703233353","klas.blomgren@regionstockholm.se",{"name":39,"role":35,"phone":40,"phoneExt":31,"email":41},"Gustaf Hellspong, MD, PhD Student","0707308144","gustaf.hellspong@regionstockholm.se",[43,61],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Karolinska Universitetssjukhuset","NOT_YET_RECRUITING","Solna","Stockholm County","171 64","Sweden","SE",{"type":52,"coordinates":53},"Point",[54,55],18.00086,59.36004,{"lat":55,"lon":54},[58,59],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},{"name":39,"role":35,"phone":60,"phoneExt":31,"email":41},"0046707308144",{"facility":62,"status":63,"city":64,"state":31,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"HOPE","RECRUITING","Stockholm","17176",{"type":52,"coordinates":67},[68,69],18.06871,59.32938,{"lat":69,"lon":68},[72,75],{"name":73,"role":35,"phone":74,"phoneExt":31,"email":41},"Gustaf Hellspong, MD","+46812371594",{"name":76,"role":35,"phone":77,"phoneExt":31,"email":37},"Klas Blomgren, MD, professor","+46703233353",{"type":79,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[81],{"name":82,"class":83},"Rigshospitalet, Denmark","OTHER","100520029","phase-2-lithium-treatment-to-prevent-cognitive-impairment-after-brain-radiotherapy-100520029",false,"NCT06051240","Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy","LiBRA","Inclusion Criteria:\n\n* Age \\>5 years.\n* Age \\\u003C18 years at time of radiotherapy.\n* Has received cranial\u002Fcraniospinal radiation treatment of brain tumor within the last 7 years.\n* Adequate contraceptive method to prevent pregnancy\\* during the entire lithium treatment period and six months thereafter.\n* Negative pregnancy test\\* at screening, at start of study treatment, and monthly thereafter.\n* Written informed consent from patient and\u002For caregiver.\n\nExclusion Criteria:\n\n* Allergy\u002Fhypersensitivity to lithium or any of the excipients\n* Renal failure (Cystatin C derived Glomerular Filtration Rate \\\u003C 60).\n* Cardiac failure or heart disease, including Brugada syndrome (or family history thereof).\n* Uncontrolled hypothyroidism.\n* Pregnancy or breast feeding.\n* Severe fluid or electrolyte imbalance.\n* Karnofsky-Lansky score \\\u003C 60.\n* Other condition deemed incompatible with inclusion in this study (estimated 2 year survival prognosis less than 25 %, expected poor protocol compliance, inability to swallow tablets, language difficulties).\n* Inclusion in other study protocol precluding inclusion in this study.","ALL","5 Years",{"count":94,"type":95},84,"ESTIMATED","INTERVENTIONAL",[98],"PHASE2","Randomized, placebo-controlled, double-blinded, parallel group clinical trial to investigate if 6 months of oral lithium tablets (S-lithium 0,5-1,0 mmol\u002Fl) will prevent cognitive decline after brain radiotherapy in pediatric brain tumor survivors.\n\nPrimary outcome measure is Processing Speed Index (PSI) 2 years after start of study treatment.",[101,102,103,104,105,106,107],"Cognitive Impairment","Cognitive Decline","Radiotherapy Side Effect","Radiotherapy; Complications","Brain Tumor","Memory Impairment","Late Effect of Radiation",[109,110,111,112,113,114,115,116,117,118],"lithium","neuroprotection","neuroprotective","regenerative","prevention","radiation","pediatric brain tumor","brain tumor","cognition","cognitive","2024-04-11",{"date":121,"type":122},"2024-04-12","ACTUAL",{"date":124,"type":122},"2024-02-16",{"date":126,"type":95},"2033-08-31",{"name":5,"class":6},2]