[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"focal-onset-seizure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:focal-onset-seizure":75},{"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":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100609809","phase-2-a-long-term-study-of-the-safety-and-effectiveness-of-rap-219-in-adults-with-focal-onset-seizures-100609809",false,"NCT07219407","A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures","An Open-label, Long-term Study Evaluating RAP-219 in Adult Participants With Refractory Onset Seizures","Inclusion Criteria:\n\n* Completion of the associated parent study (RAP-219-FOS-201) treatment period with acceptable tolerability, per Investigator.\n* Diagnosis of refractory focal epilepsy\n* Stable RNS(c) system settings\n* A demonstrated history of compliance with RNS(c) system data interrogation and upload\n* Good overall health other than focal epilepsy, per Investigator.\n* BMI ≥ 18 kg\u002Fm\\^2 and ≤ 45 kg\u002Fm\\^2\n* Willing and able to adhere to all aspects of the protocol.\n\nExclusion Criteria:\n\n* Known of hypersensitivity to RAP-219\n* Any clinically unstable or serious medical, neurological (other than epilepsy), psychological, or behavioral problem; laboratory or ECG finding that would increase participant risk or should otherwise exclude the patient from participation, as assessed by Investigator\n* Pregnancy, lactation, or individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods","ALL","18 Years","70 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine RAP-219 Long- term safety and open-label antiseizure activity in patients with Refractory Focal Epilepsy.",[27,28,29,30,31,32],"Focal Epilepsy","Epilepsy","Refractory Focal Epilepsy","Seizure","Focal Seizure","Focal Onset Seizure",[34,28,35,36],"Focal Seizures","RNS","Long episode","RECRUITING","2026-01-22",{"date":40,"type":41},"2026-01-23","ACTUAL",{"date":43,"type":41},"2025-12-15",{"date":45,"type":21},"2028-02-03",{"name":47,"class":48},"Rapport Therapeutics Inc.","INDUSTRY",7,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":55,"conditions":61,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100585898","phase-2-an-open-label-trial-to-evaluate-the-efficacy-and-safety-of-prax-628-in-adults-with-focal-onset-or-tonic-clonic-seizures-100585898","NCT06908356","An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures","An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients With Focal Onset or Primary Generalized Tonic-Clonic Seizures","Inclusion Criteria:\n\n* A diagnosis of focal onset seizures or idiopathic generalized tonic clonic seizures.\n* Evidence by computed tomography (CT) or magnetic resonance imaging (MRI) in the past that has ruled out a progressive cause of epilepsy.\n* Participant must have been receiving stable doses of allowable ASMs (a minimum of 1 and a maximum of 3 ASMs).\n* Participant and\u002For caregiver (if applicable) self-reports at least 2 countable focal onset seizures per month for focal onset patients, or 1 countable generalized tonic-clonic seizure per month in the 3 months immediately prior to the Screening\u002FObservation Period for PGTCS patients.\n\nExclusion Criteria:\n\n* History of pseudo or psychogenic seizures, or cluster seizures only, within the 12-month period preceding study entry where the individual seizures cannot be counted, or an episode of convulsive status epilepticus requiring hospitalization and intubation in the 12 months prior to Screening.\n* Planned epilepsy surgery during the course of the clinical trial.\n* History of neurosurgery for seizures \\\u003C1 year prior to enrollment, or radiosurgery \\\u003C2 years prior to enrollment.\n* Schizophrenia and obsessive-compulsive disorder, or other serious mental health disorders.\n* Active suicidal plan\u002Fintent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt.\n* Participants with a history of malignancy, myeloproliferative or lymphoproliferative disorders within the past 5 years are excluded.\n* History of cardiac disease(s)\u002Fcardiac conduction disorders\u002For cardiac structural abnormality(ies).\n* Is pregnant or breastfeeding at the time of Screening, or has a positive serum pregnancy test at Screening or is planning to become pregnant during the clinical trial or within 14 days of the last study drug dose.\n* Has received any other experimental or investigational drug, device or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, or any prior use of gene therapy.\n* Vigabatrin: Use in the last 5 years without stable visual fields tested twice over the 12 months after the last dose of vigabatrin.\n* Felbamate: If used as a concomitant ASM, patients must be on felbamate for at least 2 years, with a stable dose for 2 months prior to Screening. If a patient received felbamate in the past, it must have been discontinued 2 months prior to Screening.","75 Years",{"count":59,"type":21},50,[24],[32,62],"Primary Generalized Epilepsy",[32,62,64],"Tonic-Clonic","2025-03-26",{"date":67,"type":41},"2025-04-03",{"date":69,"type":41},"2025-01-10",{"date":71,"type":21},"2025-07",{"name":73,"class":48},"Praxis Precision Medicines",11,"Focal-Onset Seizure"]