[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Oils4Cure\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100623948","phase-3-treatment-with-full-spectrum-cannabis-extract-of-refractory-epilepsy-associated-with-tuberous-sclerosis-complex-tsc-100623948",false,"NCT07403266","Treatment With Full-spectrum Cannabis Extract of Refractory Epilepsy Associated With Tuberous Sclerosis Complex (TSC)","Spectrum","Inclusion Criteria:Patients of any sex between 2 and 65 years of age (both included) Diagnosis confirmed by the TSC investigator (by clinical criteria and\u002For genetic study).\n\nRefractory epilepsy secondary to TSC, defined as that not responding successfully to traditional AEDs (2 or more), ketogenic diet, vagal nerve stimulator, and\u002For whose patients are not candidate for epilepsy surgery or persist with seizures after surgery.\n\nPatients with a minimum of 4 epileptic seizures or more within 4 weeks prior to the initiation of the assigned treatment in the trial, with observable external signs (loss of consciousness or motor component).\n\nStability in AEDs doses, and in ketogenic diet\u002Fprogramming of the device associated with the vagal nerve stimulator with no changes for at least 4 weeks prior to the initiation of the assigned treatment.\n\nPatients who are in treatment with 3 or less AEDs at the time of signing the informed consent. For the purposes of assessing eligibility, Clobazam will not be counted as AED Willingness by patients or caregivers\u002Ffamily members (in case of patients who are minors or under legal guardianship) to complete the seizure diary.\n\nIn case of women of child-bearing age, for safety, those who agree to follow the required contraceptive measures from the signing of the informed consent until three months after stop the intake of the investigational medicinal product.\n\nPatients who have signed the informed consent either by themselves or through a legal representative.\n\n\\-\n\nExclusion Criteria:Patients who are receiving treatment on corticoids at the time of signing the informed consent.\n\nPregnancy. Breastfeeding women To have participated in another clinical trial, unless at least 5 half- lives of the investigational product have elapsed, or 12 weeks, if it is a product with cannabis oil.\n\nPatients who have received products with cannabis oil in the last 12 weeks. Patients who did not correctly follow the AED treatment in the 4 weeks prior to the intervention assigned in the trial.\n\nPatients who changed medication or AED dose, ketogenic diet, or the vagal stimulator during the 4 weeks prior to the initiation of the intervention assigned in the trial.\n\nCardiac, renal, and hepatic failure, pancreatic insufficiency, or hematologic dysfunction with values above the normal limits of creatinine and urea; values 2 times the normal limits of transaminases, lipases, and serum amylase; platelets \\\u003C 80000\u002Fmm3, and white blood cell count \\\u003C3000\u002Fmm3.\n\nUncontrolled severe medical condition such as: hepatic disease, increased bilirubin levels more than twice the normal limit, cirrhosis, chronic hepatitis (hepatitis B or C), uncontrolled diabetes (defined as blood glucose \\>150 mg%), (chronic or acute) active infections or uncontrolled severe infections, or active bleeding.\n\nPatients or family\u002Fcaregivers (in case of patients who are minors or under legal guardianship) who does not agree to comply with the requirements and trial visits or present a high risk of non-compliance with the protocol, according to the treating physician.\n\nAllergy to any of the components of the investigational medicinal product\u002Fplacebo.\n\nFamily (considering only first-degree blood relatives) or personal history of schizophrenia.\n\nPersonal history of suicide attempts.\n\n\\-","ALL","2 Years","65 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","1\\. To assess treatment efficacy with YCJ-01 by changes in the number of epileptic seizures in patients with refractory epilepsy secondary to Tuberous Sclerosis Complex. 2. To assess the safety of the treatment with YCJ-01 in patients with refractory epilepsy secondary to Tuberous Sclerosis Complex.",[27],"Tuberous Sclerosis Complex (TSC)",[29],"Refractary Epilepsy","RECRUITING","2026-02-04",{"date":33,"type":34},"2026-02-11","ACTUAL",{"date":36,"type":34},"2024-06-01",{"date":38,"type":21},"2027-06",{"name":40,"class":41},"Oils4Cure","INDUSTRY",""]