[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643929":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":50,"collaborators":54,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"UMC Utrecht","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active treatment with CBD oil","ACTIVE_COMPARATOR","All participants will undergo one to three treatment cycles. In each cycle, each participant will receive both the active comparator as the placebo comparator. The investigational medicinal product (IMP): Bedrolite, which is a full spectrum extract of Cannabis sativa L. \"Rensina\", with a CBD:THC ratio of approximately 26:1. Cannabidiol will be titrated up to a dosage of 2.5-20mg\u002Fkg\u002Fday, which is in line with previous clinical trials. There is scarce evidence in literature on optimal dosing of this specific CBD:THC preparation, therefore, directly after the baseline period, a titration phase is used to determine the maximum tolerated dose. The maximum daily dose is set at 1000mg CBD per day. Therefore, for patients weighing over 50 kg, a calculation weight of 50 kg will be used.",[13],"Drug: Cannabidiol (CBD) oral solution",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo is identical to the IMP apart from the active ingredients (less than 0.5% CBD\u002F0.02%THC ), with identical packaging.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Cannabidiol (CBD) oral solution","Bedrolite, which is a full spectrum cannabis extract with 10%CBD\u002F0.4%THC. Cannabidiol will be titrated up to a dosage of 2.5-20mg\u002Fkg\u002Fday, dosed twice daily.",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Cannabis extract with less than 0.5% CBD\u002F0.02%THC",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Marit van de Wiel, MD","CONTACT","088 755 5555","m.vandewiel@umcutrecht.nl",[37],{"facility":38,"status":39,"city":40,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":26},"University Medical Center Utrecht","RECRUITING","Utrecht","3584 CX","Netherlands","NL",{"type":45,"coordinates":46},"Point",[47,48],5.12222,52.09083,{"lat":48,"lon":47},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","F.E. (Floor) Jansen","Associate Professor Pediatric Neurology",[55,57,60,62,64],{"name":56,"class":6},"Stichting Epilepsie Instellingen Nederland",{"name":58,"class":59},"Epilepsiecentrum Kempenhaeghe","INDUSTRY",{"name":61,"class":6},"Erasmus Medical Center",{"name":63,"class":6},"Maastricht University Medical Center",{"name":65,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development","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":77,"type":78},50,"ESTIMATED","INTERVENTIONAL",[81],"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.",[84,85,86],"Refractory Epilepsy in Children","Refractory Epilepsy","Epilepsy",[88,89,90,91,92,93],"Refractory epilepsy","rare diseases","Cannabidiol.","bedrolite","n-of-1 trial","medicinal cannabis","2026-06-19",{"date":96,"type":97},"2026-06-25","ACTUAL",{"date":99,"type":97},"2025-02-06",{"date":101,"type":78},"2027-12",{"name":5,"class":6},1]