[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-generalized-epilepsy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-generalized-epilepsy":27},{"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":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":14,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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",false,"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.","ALL","18 Years","75 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2",[26,27],"Focal Onset Seizure","Primary Generalized Epilepsy",[26,27,29],"Tonic-Clonic","RECRUITING","2025-03-26",{"date":33,"type":34},"2025-04-03","ACTUAL",{"date":36,"type":34},"2025-01-10",{"date":38,"type":21},"2025-07",{"name":40,"class":41},"Praxis Precision Medicines","INDUSTRY",11]