[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550106":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":29,"locations":36,"responsibleParty":70,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":23,"enrollmentInfo":87,"targetDuration":23,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":23,"overallStatus":58,"whyStopped":23,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Tata Memorial Centre","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"STANDARD","In the standard arm, patients will continue on the same dose and schedule of levetiracetam (prescribed in the range of 1000-3000 mg\u002F day in 2-3 divided doses) for a duration of 2 years.",[12],"Drug: Levetiracetam",{"label":14,"type":14,"description":15,"interventionNames":16},"EXPERIMENTAL","In the experimental arm, levetiracetam will be tapered by 250- 500 mg every week and then stopped.",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Levetiracetam","Levetiracetam is usually preferred in brain tumor-related epilepsy. Levetiracetam is a second-generation antiepileptic drug that binds to synaptic vesicle glycoprotein SV2A, which interferes with the release of neurotransmitters from the synaptic vesicle and control seizure by multiple mechanisms.",[14,9],null,[25],{"name":26,"affiliation":27,"role":28},"Archya Dasgupta","Tata Memorial Centre Mumbai","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Archya Dasgupta, MD","CONTACT","02224177000","6861","archya1010@gmail.com",[37,57],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Manipal Academy of Higher Education","NOT_YET_RECRUITING","Udupi","Karnataka","576104","India","IN",{"type":46,"coordinates":47},"Point",[48,49],74.74617,13.33467,{"lat":49,"lon":48},[52,56],{"name":53,"role":32,"phone":54,"phoneExt":23,"email":55},"Umesh Velu","+91-8700105161","umesh.vellu@manipal.edu",{"name":53,"role":28,"phone":23,"phoneExt":23,"email":23},{"facility":5,"status":58,"city":59,"state":60,"zip":61,"country":43,"countryCode":44,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"RECRUITING","Mumbai","Maharashtra","400012",{"type":46,"coordinates":63},[64,65],72.88261,19.07283,{"lat":65,"lon":64},[68,69],{"name":26,"role":32,"phone":33,"phoneExt":34,"email":35},{"name":26,"role":28,"phone":23,"phoneExt":23,"email":23},{"type":28,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Dr Archya Dasgupta","Assistant Professor, Radiation Oncology",[74],{"name":75,"class":76},"Manipal Academy for Higher Education","UNKNOWN","100550106","phase-3-short-versus-long-term-levetiracetam-in-brain-tumors-100550106",false,"NCT06442748","Short Versus Long-term Levetiracetam in Brain Tumors","Short Versus Long-term Levetiracetam in Brain Tumors: A Phase 3 Randomized Controlled Trial (LIBRA)","LIBRA","Inclusion Criteria: • Age ≥ 18years\n\n* History of seizure\n* Histological diagnosis of primary brain tumor\n* Supratentorial location of primary tumor\n* Controlled on levetiracetam monotherapy for 6 months\n* Index surgery within 1 year\n* Karnofsky Performance Scale (KPS) ≥ 50\n\nExclusion Criteria:\n\n* KPS \\\u003C 50\n* No history of seizure\n* Unclear history of seizure episodes in the past\n* Use of antiepileptics other than levetiracetam in the previous 6 months\n* No histological diagnosis\n* Progressive disease\n* Brain metastasis\n* Altered mental status with deficits in understanding or inability to consent to the study","ALL","18 Years",{"count":88,"type":89},604,"ESTIMATED","INTERVENTIONAL",[92],"PHASE3","Levetiracetam is the commonly preferred anti-seizure medicine in patients with brain tumors. This drug has reduced the risk of seizure events occurring but is associated with a risk of side effects such as increased headache, drowsiness, loss of muscle coordination, and psychological challenges in patients. In patients undergoing appropriate treatment for brain tumors and controlled of seizures in the initial few months of levetiracetam, the chance of further seizures is relatively low. The optimal duration to give levetiracetam is not well defined for these patients, and currently as standard treatment levetiracetam is continued for 2-3 years. This study aims to answer this question by comparing patients on a short course of levetiracetam (experimental arm) versus a longer course of levetiracetam (standard arm), with the anticipation that a shorter duration of treatment will not lead to increased seizure episodes.",[95,96,97,20],"Seizures","Brain Tumors","Antiepileptics","2026-02-11",{"date":100,"type":101},"2026-02-13","ACTUAL",{"date":103,"type":101},"2024-07-04",{"date":105,"type":89},"2031-06-01",{"name":5,"class":6},2]