[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-epilepsy-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-epilepsy-in-children":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100643929","phase-3-cannabidiol-as-add-on-therapy-for-children-with-refractory-epilepsy-cbd-un1que-a-high-quality-individualized-approach-a-series-of-n-of-1-trials-100643929",false,"NCT07668856","Cannabidiol as add-on Therapy for Children With Refractory Epilepsy (CBD-uN1que), a High-quality Individualized Approach: a Series of N-of-1 Trials","CBD-uN1que","Inclusion Criteria:\n\n* Minimum age of 1 year old and maximum age of 18 years old.\n* Confirmed diagnosis of refractory epilepsy according to ILAE criteria\n* At least 4 countable seizures (not all in one week) of epileptic origin, during the 4-week baseline period while receiving care as usual.\n* All medication doses or other interventions for epilepsy must have been stable for one month prior to screening and the participants\u002Fparents and treating physicians are willing to maintain the current treatment regimen throughout the trial.\n* Informed consent\u002F of legal representative\u002F parents.\n* Presence of a consistently available patient caregiver for proxy-reports.\n\nExclusion Criteria:\n\n* Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (cannabis extract and refined peanut oil, generally safe for patients with peanut allergy)\n* History or current signs of significantly impaired liver function, such as bilirubin level ≥ 2 x upper limit of normal, or presence of liver damage as indicated by levels of alanine aminotransferase and\u002For aspartate aminotransferase ≥ 3 x upper limit.\n* Pregnancy, breastfeeding, or intention to become pregnant throughout the trial or within 3 months of completing treatment\n* Cardiac disease including: Structural heart disease with hemodynamic significance, heart failure, ischemic heart disease, Brugada syndrome, long-QT syndrome, cardiac arrythmia\n* Glaucoma\n* Ongoing evaluation for epilepsy surgery\n* Implementation of vagal nerve stimulation within 3 months prior to screening and unwillingness to delay inclusion until stable settings of vagal nerve stimulation are reached\n* Starting a ketogenic diet within 3 months prior to screening and unwillingness to delay inclusion until a stable ketogenic diet is reached\n* Unstable medical condition, other than refractory epilepsy, that is of significant influence on participation in the trial; significance to be determined with the treating physician\u002Fpediatric neurologist\n* History of recreational or medicinal cannabis use, or cannabinoid-based medications, within three months prior to screening and the patient is unwilling to abstain for the duration of the study\n* Planned intervention under general anesthesia interfering with the baseline period; or any planned major surgery within the duration of the trial\n* Expected inability to undergo blood sampling due to anxiety or resistance\n* Use of clobazam dosage of \\> 0,5 mg\u002Fkg\u002Fday in the last month","ALL","1 Year","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this clinical trial is to learn if cannabidiol (\"CBD-oil\") works to treat severe epilepsy in children. It will also learn about the safety of cannabidiol. The main questions it aims to answer are:\n\n* Does cannabidiol lower the number of seizure in children with severe epilepsy?\n* Does cannabidiol effect other outcomes such as behaviour, sleep, communication, activities?\n* What medical problems do participants have when taking cannabidiol?\n\nResearchers will compare cannabidiol to a placebo (a look-alike oil that contains no cannabidiol) to see if drug cannabidiol works to treat severe epilepsy. All participants will receive both the cannabidiol and the placebo during different periods. At the end of the trial, we will evaluate for each patient seperately, whether seizures were less or more frequent during cannabidiol periods or placebo periods, to see what works best for every patient seperately.\n\nParticipants will:\n\n* Register their seizures in a digital application during 4 to 6 periods. During these periods, CBD oil of placebo will be provided\n* Take CBD oil during 2 to 3 periods. One period will last around 7 weeks.\n* Also take placebo oil during the other 2 to 3 periods\n* Have a blood test every 7 weeks to monitor for safety and possible adverse effects\n* Visit the clinic once every 15 weeks for checkups and tests\n* Fill in questionnaires about quality of life, functioning, sleep, behaviour, epilepsy severity every 7 weeks.",[27,28,29],"Refractory Epilepsy in Children","Refractory Epilepsy","Epilepsy",[31,32,33,34,35,36],"Refractory epilepsy","rare diseases","Cannabidiol.","bedrolite","n-of-1 trial","medicinal cannabis","RECRUITING","2026-06-19",{"date":40,"type":41},"2026-06-25","ACTUAL",{"date":43,"type":41},"2025-02-06",{"date":45,"type":21},"2027-12",{"name":47,"class":48},"UMC Utrecht","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":18,"enrollmentInfo":58,"targetDuration":60,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":49},"100597894","non-helium-magnetoencephalography-in-pediatric-refractory-epilepsy-100597894","NCT07064421","Non-Helium Magnetoencephalography in Pediatric Refractory Epilepsy","Non-Helium Magnetoencephalography for Clinical Management of Refractory Epilepsy in Children: An Observational Cohort Study","Inclusion Criteria:\n\n1. Age range: 3-18 years old;\n2. Clinically diagnosed with refractory epilepsy;\n3. Capable of cooperating with magnetoencephalography evaluation and recording.\n\nExclusion Criteria:\n\n1. Patients with serious comorbidities or neurological or psychiatric disorders that affect magnetoencephalography examination.\n2. Patients using drugs that affect central nervous system function;\n3. Patients who are not suitable for surgical procedures;\n4. Patients with progressive neurological disorders.","3 Years",{"count":59,"type":21},100,"12 Months","OBSERVATIONAL","The goal of this observational study is to evaluate the effectiveness of Magnetoencephalography (MEG) in the preoperative assessment of children with refractory epilepsy, particularly in identifying the seizure focus, and to compare it with the gold standard methods of Stereo-electroencephalography (SEEG) and Electrocorticography (ECoG).\n\nThe main questions this study aims to answer are:\n\n1. How consistent is MEG with SEEG\u002FECoG in locating the epileptic focus in children with refractory epilepsy?\n2. What is the clinical efficacy of MEG in identifying epileptic foci?\n\nParticipants will:\n\n1. Be divided into 2 groups: the case group and the control group. Participants in the case group will undergo both MEG and SEEG\u002FECoG for preoperative assessment, while patients in the control group will undergo only SEEG\u002FECoG before surgery.\n2. Be followed up at 1, 3, 6, and 12 months after surgery to assess seizure control, neurological function, and quality of life.",[27],[29,65],"Magnetoencephalography","2025-07-03",{"date":68,"type":41},"2025-07-14",{"date":70,"type":41},"2024-11-05",{"date":72,"type":21},"2027-12-31",{"name":74,"class":48},"Guangzhou Women and Children's Medical Center"]