[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571403":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":20,"responsibleParty":33,"collaborators":36,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":20,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":20,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":62,"whyStopped":20,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":20},{"fullName":5,"class":6},"Xuanwu Hospital, Beijing","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Open label single arm, drug propanolol","EXPERIMENTAL","All subjects will receive the experimental drug",[13],"Drug: Propranolol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Propranolol","Oral administration is given solely for the epilepsy seizure event. Dosage: 20mg per dose; The patient's blood pressure and heart rate are monitored after the seizure; if the SBP is above 90 mmHg and the heart rate is above 60 beats per minute, then patients are instructed to take propranolol within 1 hour of a seizure . If the seizure frequency is excessively high, the interval between doses should be no less than 6 hours and the medication should not be administered more than 3 times a day.",[9],null,[22,25],{"name":23,"affiliation":5,"role":24},"Liankun Ren, MD","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Zhuo Huang, PhD","Peking University School of Pharmaceutical Sciences",[29],{"name":23,"role":30,"phone":31,"phoneExt":20,"email":32},"CONTACT","+86 13681576621","renlk2022@outlook.com",{"type":24,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Liankun_Ren","Professor",[37],{"name":38,"class":6},"Peking University","100571403","early-phase-1-propranolol-adjuvant-treatment-of-focal-refractory-epilepsy-patfre-100571403",false,"NCT06719804","Propranolol Adjuvant Treatment of Focal Refractory Epilepsy (PATFRE)","The Safety and Efficacy Evaluation of Propranolol as an Adjunctive Treatment for Focal Refractory Epilepsy: A Pilot Study","Inclusion Criteria:\n\n* 18-60 years of age.\n* Meet the 2017 International League Against Epilepsy (ILAE) diagnostic criteria for for focal seizures or focal seizures progressing to bilateral tonic-clonic seizures.\n* Diagnosed with refractory epilepsy, having used at least two AEDs without effectiveness for 2 years. No drug interaction between current AEDs and propranolol, and a stable dose for at least 12 weeks prior to enrollment.\n* Seizure duration ≥1 minute, with accompanying sensory impairment.\n* At least 6 focal seizures within the 12 weeks preceding enrollment.\n* EEG or MRI\u002FCT results within the past 2 years, confirming the diagnosis of focal epilepsy.\n* The use of vagus nerve stimulation (VNS) and deep brain stimulation (DBS) is permitted, need to implant at least 5 months and stable for at least 12 weeks before enrollment.The parameters should keep unchanged until the end of the study.\n* Informed consent signed.\n\nExclusion Criteria:\n\n* Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations\n* Psychogenic non-epileptic seizures within 12 months;\n* Treatable causes of epilepsy (such as metabolic disorders, toxicity, infections, space-occupying lesions, or identified genetic abnormalities)\n* Patients with only non-motor focal seizures, as classified by the 2017 ILAE.\n* Seizure clusters within the 12 months.\n* Tonic-clonic status epilepticus within12 months.\n* Free of major medical illnesses including:\n* Cardiac diseases (history of cardiac valve disease, coronary artery disease, congestive heart failure, A-V block, peripheral vascular disease, any cardiac arrhythmia\u002Fbradycardia)\n* Histories of asthma, bronchospastic disease, or obstructive pulmonary disease\n* Severe allergic reactions to medications which are included in the beta blocker family\n* Currently treated with a beta adrenergic receptor antagonist or Previously used within 12 months\n* Uncontrolled Diabetes (HbA1c of ≤ 8 if previously tested)\n* Uncontrolled hypotension\n* Immunodeficiency disorders, liver or kidney diseases, acute infections, or advanced-stage tumors.\n* Participants with a history of medical conditions or surgeries that, in the investigator's judgment, could affect the absorption, distribution, or metabolism of the study drug (e.g., active peptic ulcers, ulcerative colitis, Crohn's disease, or bowel obstruction) or those with difficulty swallowing.\n* Participants with any medical condition, mental health status, cognitive impairment, or intellectual disability that the investigator believes could increase the risk to the participant or interfere with their ability to participate in the clinical trial.\n* Participants meeting any of the following laboratory criteria: alanine aminotransferase (ALT) \\>2× upper limit of normal (ULN), aspartate aminotransferase (AST) \\>2× ULN, alkaline phosphatase (ALP) \\>2× ULN, platelet count \\\u003C80×10\\^9\u002FL, neutrophil count \\\u003C1.8×10\\^9\u002FL, or creatinine clearance (CLcr) \\\u003C30 mL\u002Fmin (calculated by the Cockcroft-Gault formula).\n* In the period of pregnancy, childbirth, lactation.\n* Alcohol abuse or drug misuse within 2 years prior to medication.\n* Participation in another clinical study within 3 months;","ALL","18 Years","60 Years",{"count":50,"type":51},15,"ESTIMATED","INTERVENTIONAL",[54],"EARLY_PHASE1","The aim of this study is to evaluate the clinical efficacy of propranolol as an adjunctive treatment for refractory epilepsy. The significance of this research lies in exploring whether propranolol, as an inhibitor of the CAMP-PKA-MEK\u002FERK pathway, can provide anticonvulsant effects for a wider range of refractory epilepsy patients. The study holds the potential to offer a novel adjunctive anticonvulsant treatment strategy targeting the CAMP-PKA-MEK\u002FERK pathway, specifically administered for seizure events, and applicable to various forms of refractory epilepsy.",[57],"Epilepsy, Drug Resistant",[17,59,60,61],"Focal Refractory Epilepsy","CAMP-PKA-MEK\u002FERK pathway","non-selective beta-adrenergic antagonists","NOT_YET_RECRUITING","2024-12-06",{"date":65,"type":66},"2024-12-10","ACTUAL",{"date":68,"type":51},"2024-12-05",{"date":70,"type":51},"2028-12-01",{"name":5,"class":6}]