[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473894":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":46,"centralContacts":51,"locations":60,"responsibleParty":84,"collaborators":10,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":10,"studyType":103,"phases":10,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14,17,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Controls",null,"Healthy volunteers with no pre-existing or current psychiatric, neurological or server somatic illness.",[13],"Drug: Levetiracetam",{"label":15,"type":10,"description":16,"interventionNames":10},"Cohort I","Patients who have a history of only one epileptic seizure.",{"label":18,"type":10,"description":19,"interventionNames":20},"Cohort II","Patients who are newly diagnosed with epilepsy.",[21,22],"Drug: Levetiracetam Tablets","Drug: Lamotrigine tablet",{"label":24,"type":10,"description":25,"interventionNames":26},"Cohort III","Patients who are newly diagnosed with epilepsy and have an epileptogenic lesion on MRI concordant with seizure semiology and\u002For EEG.",[13],[28,35,40],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Levetiracetam","Healthy subjects and patients in Cohort III will undergo a 120 min. \\[11C\\]-UCB-J PET-MR brain scan followed by intravenous administration of levetiracetam after approx. 60 min. in a displacement paradigm. Before, during and after the intervention arterial spin labeling and resting-state functional MRI will be acquired.\n\nTo measure the radiolabelled tracer's arterial input function, including its radiolabelled metabolites, blood samples will be drawn during the PET scan from an arterial catheter.\n\nThe selected regions for the primary analyses are the epileptogenic lesion(s) (patients) and the neocortex, hippocampus, entorhinal cortex, fusiform gyrus, dorsolateral prefrontal cortex, ventrolateral prefrontal cortex, orbitofrontal cortex, striatum, anterior cingulate cortex and amygdala. \\[11C\\]-UCB-J binding, volume of distribution and SV2A occupancy will be quantified by analyzing the PET images with well-validated kinetic models.",[24,9],[34],"[11C]-UCB-J PET-MR scan",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Levetiracetam Tablets","Patients in Cohort II will be randomized to treatment with an ASM (levetiracetam) in accordance with standard treatment procedures. The patients will enter a 4 weeks titration period receiving increasing doses. During weeks 5-30, patients will enter an evaluation period where the dose can be increased (continued seizures) or decreased (adverse reactions). In cases of unacceptable seizure control and\u002For intolerable adverse reactions; shift to lamotrigine arm.",[18],[30],{"type":29,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Lamotrigine tablet","Patients in Cohort II will be randomized to treatment with an ASM (lamotrigine) in accordance with standard treatment procedures. The patients will enter a 6 weeks titration period receiving increasing doses. During weeks 5-30, patients will enter an evaluation period where the dose can be increased (continued seizures) or decreased (adverse reactions). In cases of unacceptable seizure control and\u002For intolerable adverse reactions; shift to levetiracetam arm.",[18],[45],"Lamotrigine",[47],{"name":48,"affiliation":49,"role":50},"Lars Hageman Pinborg, MD","Neurobiological Research Unit","PRINCIPAL_INVESTIGATOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":10,"email":56},"Maja Marstrand-Jørgensen, MD","CONTACT","+45 35 45 36 43","maja.marstrand-jorgensen@nru.dk",{"name":48,"role":54,"phone":58,"phoneExt":10,"email":59},"+45 35 45 67 12","lars.pinborg@nru.dk",[61],{"facility":62,"status":63,"city":64,"state":10,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Neurobiology Research Unit, Rigshospitalet","RECRUITING","Copenhagen","2100","Denmark","DK",{"type":69,"coordinates":70},"Point",[71,72],12.56553,55.67594,{"lat":72,"lon":71},[75,79,81],{"name":76,"role":54,"phone":77,"phoneExt":10,"email":78},"Gitte M Knudsen, DMSc","+45 35456720","gmk@nru.dk",{"name":80,"role":50,"phone":10,"phoneExt":10,"email":10},"Lars H. Pinborg, DMSc",{"name":82,"role":83,"phone":10,"phoneExt":10,"email":10},"Maja R. Marstrand-Joergensen, MD","SUB_INVESTIGATOR",{"type":85,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Gitte Moos Knudsen","professor, MD neurology","100473894","precision-medicine-in-the-treatment-of-epilepsy-100473894",false,"NCT05450822","Precision Medicine in the Treatment of Epilepsy","The BrainDrugs-Epilepsy Study: A Prospective Open-label Cohort Precision Medicine Study in Epilepsy","BDE","Inclusion Criteria for healthy subjects:\n\n* No history of current or past psychiatric or other major medical conditions\n\nExclusion Criteria for healthy subjects:\n\n* Current or previous neurological disease, severe somatic disease, or consumption of medical drugs likely to influence the test results\n* Non-fluent in Danish or pronounced visual or auditory impairments\n* Current or past learning disability\n* Pregnancy or lactation (females)\n* Participation in experiments with radioactivity (\\>10 mSv) within the last year or significant occupational exposure to radioactivity\n* Contraindications for MRI (pacemaker, metal implants, etc.)\n* Severe head injury\n* Alcohol or drug abuse\n* Drug use other than tobacco and alcohol within the last 30 days\n* Hash \\> 50 x lifetime\n* Drugs \\> 10 x lifetime (for each substance)\n* Current psychoactive medication\n* Any current or former primary psychiatric disorder (Axis I WHO ICD-10 diagnostic classification)\n\nInclusion Criteria for patients:\n\n* Cohort I-II: Age between 16 and 55 years\n* Cohort III: Age between 18 and 55 years\n* Cohort I: Semiology of first seizure raises a strong suspicion of epilepsy but do not fulfill International League Against Epilepsy (ILAE) diagnostic criteria\n* Cohort II-III: Diagnosed with epilepsy according to ILAE criteria\n* Cohort III: Epileptogenic lesion on MRI concordant with seizure semiology and\u002For EEG\n\nExclusion criteria for patients:\n\n* Cohort I-III: Life expectancy \\\u003C 10 years\n* Cohort I-III: Known genetic syndromes, psychomotor retardation or disease associated with gross morphological brain changes such as brain tumor, major stroke or major traumatic brain injury\n* Cohort I-III: Body weight less than 40 kg\n* Cohort I-III: Reduced kidney function (i.e., glomerular filtration rate (GFR) \\\u003C 80 ml\u002Fmin or 50 ml\u002Fmin for patients 16-17 years old or ≥18 years old, respectively),\n* Cohort I-III: Moderate reduced liver function\n* Cohort I-III: Cardiac conduction disorders (e.g., Brugada syndrome, long QT-syndrome)\n* Cohort I-III: Medication incompatible with study aims or causing interactions with the administered levetiracetam or lamotrigine therapy (e.g., SV2A binding agents, monoamine oxidase inhibitors, fluvoxamin, methotrexate, benzodiazepines, phenobarbital, carbamazepine, valproate, regular use of other ASMs)\n* Contraindication for MRI (e.g., magnetic implants, pacemaker)\n* Inability to complete PET (Cohort III) or MRI scans (Cohort I-III) (e.g., claustrophobia, issues with back pain)\n* Cohort III: Exposure to radioactivity \\>10 mSv within the last year or significant occupational exposure to radioactivity\n* Pregnancy or lactation\n* Cohort I-III: Non-fluency in Danish or pronounced visual or auditory impairments or severe intellectual disability\n* Cohort I-III: Current or previous alcohol or drug abuse",true,"ALL","16 Years","55 Years",{"count":101,"type":102},550,"ESTIMATED","OBSERVATIONAL","Primary objectives:\n\nThe purpose of this study is to identify single and composite biomarkers (from neuroimaging, electrophysiological, and non-imaging biological measures), clinical measures (from cognitive, psychometric, and behavioral test scores), and risk\u002Fprotective factors (e.g., from medical history, socioeconomic status, coping, lifestyle) that can:\n\n1. Predict antiseizure medication (ASM) treatment outcome, psychiatric, cognitive, or behavioral comorbidities, and quality of life in newly diagnosed epilepsy patients (Cohort II-III).\n2. Predict a second epileptic seizure\u002Fepilepsy diagnosis and behavioral, cognitive, psychiatric dysfunction and quality of life in patients after a first epileptic seizure (Cohort I).",[106],"Epilepsy",[108,109,110,111,112,113,114,115,116,117,118,119,120,121,122],"epilepsy","precision medicine","treatment targets","biomarkers","high density EEG","gut microbiome","longitudinal","levetiracetam","lamotrigine","neuroimaging","machine learning","treatment response","PET","MRI","Psychometrics","2024-04-09",{"date":125,"type":126},"2024-04-11","ACTUAL",{"date":128,"type":126},"2022-02-18",{"date":130,"type":102},"2031-12-31",{"name":86,"class":6},1]