[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100289463":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":59,"studyPopulation":52,"armGroups":60,"interventions":72,"overallOfficials":52,"centralContacts":85,"locations":95,"responsibleParty":160,"collaborators":164,"id":170,"slug":171,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":172,"sex":178,"minAge":179,"maxAge":52,"enrollmentInfo":180,"targetDuration":52,"studyType":183,"phases":184,"briefSummary":186,"conditions":187,"keywords":52,"overallStatus":111,"whyStopped":52,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},{"fullName":5,"class":6},"Leiden University Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":52},[9],{"measure":10,"description":11,"timeFrame":12},"Ongoing seizure freedom at 6 months","The percentage of patients with ongoing seizure freedom at 6 months","6 months",[14,18,21,24,28,31,34,37,40,43,45,48,50],{"measure":15,"description":16,"timeFrame":17},"Cumulative incidence of treatment failure for any reason","Cumulative incidence function of time to treatment failure for any reason of ASM treatment using competing risk models with death as a competing event.","36 months",{"measure":19,"description":20,"timeFrame":17},"Cumulative incidence of treatment failure for specific reasons","Cumulative incidence function of time to treatment failure for specific reasons of ASM treatment using competing risk models with death and non-applicable reasons of failure as competing events. Reasons of failure: uncontrolled seizures, adverse effects, other reasons of treatment failure, and death",{"measure":22,"description":23,"timeFrame":17},"Cumulative incidence of a first recurrent seizure","Cumulative incidence function of time to occurrence of a first recurrent seizure after ASM initiation using competing risk models with death as a competing event.",{"measure":25,"description":26,"timeFrame":27},"Adverse effects of the treatment","Severity of adverse effects of the treatment, defined as severity (grade 1-5) of intolerable adverse effects leading to ASM discontinuation according to the Common Terminology Criteria for Adverse- Events (CTCAE) version 5.0","0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively",{"measure":29,"description":30,"timeFrame":27},"Hospitalisation rate","hospitalization rate due to treatment failure",{"measure":32,"description":32,"timeFrame":33},"Health-related quality of life","0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively",{"measure":35,"description":36,"timeFrame":33},"Cognitive complaints","Cognitive complaints using MOS-CFS scores",{"measure":38,"description":39,"timeFrame":33},"Mood","Anxiety and depression using HADS scale scores",{"measure":41,"description":42,"timeFrame":33},"Performance Status","Karnofsky Performance Status Score",{"measure":44,"description":44,"timeFrame":33},"Epilepsy burden",{"measure":46,"description":47,"timeFrame":27},"Treatment response","Treatment response (e.g., maximum dosage of AED, use of add-on AED)",{"measure":49,"description":49,"timeFrame":27},"Progression-free survival",{"measure":51,"description":51,"timeFrame":27},"Overall survival",null,{"allocation":54,"interventionModel":55,"interventionModelDescription":52,"primaryPurpose":56,"observationalModel":52,"timePerspective":52,"maskingInfo":57},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":58,"maskingDescription":52,"whoMasked":52},"NONE","Currently, treatment of glioma patients with a specific anti-epileptic drug (AED) mainly depends on the physicians' preference, as there is no robust evidence from randomized controlled trials supporting the use of one specific anticonvulsant above the other in glioma patients.\n\nLevetiracetam and valproic acid are the most commonly used AEDs in glioma patients. Both drugs are used for the treatment of seizures, have similar toxicity profiles and are non-enzyme inducing AEDs, therefore not interfering with chemotherapeutic drugs. However, it is not known whether one drug is more effective than the other in reducing seizures.",[61,67],{"label":62,"type":63,"description":64,"interventionNames":65},"Levetiracetam","ACTIVE_COMPARATOR","Patients in this treatment arm will receive levetiracetam monotherapy. The dosage depends on the specific treatment step, as indicated in the protocol. In step 1, patients will receive 2x500 mg\u002Fd levetiracetam in the form of tablets. In step 2, dosage is increased to 1x250 plus 1x500 mg\u002Fd and in step 3 to 2x1000 mg\u002Fd levetiracetam. In step 4, levetiracetam is increased to 2x1500mg\u002Fd. In the fifth treatment step, patients will receive 2x1500 mg\u002Fd levetiracetam, and another AED will be added. The type and dosage of this add-on AED is according to the physician's preference, but in line with current clinical practice in the Netherlands.",[66],"Drug: Levetiracetam",{"label":68,"type":63,"description":69,"interventionNames":70},"Valproic acid","Patients in this treatment arm will receive valproic acid monotherapy. The dosage depends on the specific treatment step, as indicated in the protocol. In step 1, patients will receive 2x500 mg\u002Fd valproic acid in the form of tablets. In step 2, dosage is increased to 1x250 plus 1x500 mg\u002Fd and in step 3 to 2x1000 mg\u002Fd valproic acid. In step 4, valproic acid dosage is increased to a maximum of 2x1250mg\u002Fd. In the fifth treatment step, patients will receive 2x1250mg valproic acid, and another AED will be added. The type and dosage of this add-on AED is according to the physician's preference, but in line with current clinical practice in the Netherlands.",[71],"Drug: Valproic Acid",[73,79],{"type":74,"name":62,"description":75,"armGroupLabels":76,"otherNames":77},"DRUG","Antiepileptic drug levetiracetam",[62],[78],"Keppra",{"type":74,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"Valproic Acid","Antiepileptic drug valproic acid",[68],[84],"Depakine",[86,91],{"name":87,"role":88,"phone":89,"phoneExt":52,"email":90},"Johan AF Koekkoek, MD, PhD","CONTACT","0031715269111","j.a.f.koekkoek@lumc.nl",{"name":92,"role":88,"phone":93,"phoneExt":52,"email":94},"Monique Baas","0031715297012","baas@lumc.nl",[96,109,122,132,146],{"facility":97,"status":98,"city":99,"state":52,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":52},"Amsterdam UMC","SUSPENDED","Amsterdam","1007 MB","Netherlands","NL",{"type":104,"coordinates":105},"Point",[106,107],4.88969,52.37403,{"lat":107,"lon":106},{"facility":110,"status":111,"city":112,"state":52,"zip":52,"country":101,"countryCode":102,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Medisch Spectrum Twente","RECRUITING","Enschede",{"type":104,"coordinates":114},[115,116],6.89583,52.21833,{"lat":116,"lon":115},[119],{"name":120,"role":88,"phone":52,"phoneExt":52,"email":121},"Angelique Sijben, MD","a.sijben@mst.nl",{"facility":5,"status":111,"city":123,"state":52,"zip":124,"country":101,"countryCode":102,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Leiden","2333 ZA",{"type":104,"coordinates":126},[127,128],4.49306,52.15833,{"lat":128,"lon":127},[131],{"name":87,"role":88,"phone":89,"phoneExt":52,"email":90},{"facility":133,"status":111,"city":134,"state":52,"zip":135,"country":101,"countryCode":102,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Erasmus Medical Center","Rotterdam","3008 AE",{"type":104,"coordinates":137},[138,139],4.47917,51.9225,{"lat":139,"lon":138},[142],{"name":143,"role":88,"phone":144,"phoneExt":52,"email":145},"Joost Jongen, MD, PhD","0031107040704","j.jongen@erasmusmc.nl",{"facility":147,"status":111,"city":148,"state":52,"zip":149,"country":101,"countryCode":102,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Haaglanden Medical Center","The Hague","2501 CK",{"type":104,"coordinates":151},[152,153],4.29861,52.07667,{"lat":153,"lon":152},[156],{"name":157,"role":88,"phone":158,"phoneExt":52,"email":159},"Lara Fritz","0031703302000","l.fritz@haaglandenmc.nl",{"type":161,"investigatorFullName":162,"investigatorTitle":163,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"PRINCIPAL_INVESTIGATOR","j.a.f.koekkoek","MD PhD",[165,167,168],{"name":166,"class":6},"Medical Center Haaglanden",{"name":133,"class":6},{"name":169,"class":6},"Amsterdam UMC, location VUmc","100289463","phase-4-seizure-treatment-in-glioma-100289463",false,"NCT03048084","Seizure Treatment in Glioma","Seizure Treatment IN Glioma (STING): Comparing a Treatment Strategy With Levetiracetam Versus Treatment With Valproic Acid in Glioma Patients With a First Seizure","STING","Inclusion Criteria:\n\n* Histologically proven or suspected diffuse astrocytoma (Isocytrate Dehydrogenase-1 (IDH-1) wildtype or IDH-1 mutated), diffuse oligodendroglioma (IDH-1 mutated and 1p\u002F19q co-deleted), anaplastic astrocytoma (IDH-1 wildtype or IDH-1 mutated), anaplastic oligodendroglioma (IDH-1 mutated and 1p\u002F19q co-deleted), glioblastoma (IDH-1 wild-type or IDH-1 mutated), or diffuse astrocytoma not otherwise specified (NOS), anaplastic astrocytoma NOS, oligodendroglioma NOS, oligoastrocytoma NOS, anaplastic oligoastrocytoma NOS, anaplastic oligodendroglioma NOS or glioblastoma NOS.\n* Adult patients: ≥18 years of age\n* First epileptic seizure, no longer than 2 weeks ago\n* Monotherapy with antiepileptic drugs is considered most appropriate at the time of randomization\n* Willing to provide written informed consent\n\nExclusion Criteria:\n\n* Previously treated with antiepileptic drugs, except emergency treatment in the past 2 weeks\n* History of non-brain tumor related epilepsy\n* Pregnancy\n* Presence of contra-indications for use of levetiracetam or valproic acid","ALL","18 Years",{"count":181,"type":182},120,"ESTIMATED","INTERVENTIONAL",[185],"PHASE4","Currently, treatment with a specific anti-epileptic drug mainly depends on the physicians' preference, as there are no studies supporting the use of one specific anticonvulsant in glioma patients. The overall aim of this randomized controlled trial is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure.",[188],"Glioma","2026-08-24",{"date":191,"type":192},"2026-08-26","ACTUAL",{"date":194,"type":192},"2018-02-01",{"date":196,"type":182},"2029-07-01",{"name":5,"class":6},5]