[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585898":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":133,"collaborators":20,"id":135,"slug":20,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":20,"eligibilityCriteria":140,"healthyVolunteers":136,"sex":141,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":20,"studyType":147,"phases":148,"briefSummary":139,"conditions":150,"keywords":153,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Praxis Precision Medicines","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Open-label 30mg\u002Fday PRAX-628 for 8 weeks","EXPERIMENTAL","Participants who meet all eligibility criteria will receive 30mg of PRAX-628 for 8 weeks.",[13],"Drug: 30mg PRAX-628",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","30mg PRAX-628","Once daily oral",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Medical Director","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Head of Pharmacovigilance","CONTACT","617-300-8460","clinicaltrials@praxismedicines.com",[32,45,54,63,72,81,90,99,107,116,124],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":20},"Praxis Research Site","RECRUITING","Phoenix","Arizona","85032","United States",{"type":40,"coordinates":41},"Point",[42,43],-112.07404,33.44838,{"lat":43,"lon":42},{"facility":33,"status":34,"city":46,"state":47,"zip":48,"country":38,"cosmosGeoPoint":49,"geoPoint":53,"contacts":20},"Miami Lakes","Florida","30116",{"type":40,"coordinates":50},[51,52],-80.30866,25.90871,{"lat":52,"lon":51},{"facility":33,"status":34,"city":55,"state":56,"zip":57,"country":38,"cosmosGeoPoint":58,"geoPoint":62,"contacts":20},"Bethesda","Maryland","20817",{"type":40,"coordinates":59},[60,61],-77.10026,38.98067,{"lat":61,"lon":60},{"facility":33,"status":34,"city":64,"state":65,"zip":66,"country":38,"cosmosGeoPoint":67,"geoPoint":71,"contacts":20},"Chesterfield","Missouri","63005",{"type":40,"coordinates":68},[69,70],-90.57707,38.66311,{"lat":70,"lon":69},{"facility":33,"status":34,"city":73,"state":74,"zip":75,"country":38,"cosmosGeoPoint":76,"geoPoint":80,"contacts":20},"Hackensack","New Jersey","07601",{"type":40,"coordinates":77},[78,79],-74.04347,40.88593,{"lat":79,"lon":78},{"facility":33,"status":34,"city":82,"state":83,"zip":84,"country":38,"cosmosGeoPoint":85,"geoPoint":89,"contacts":20},"Middletown","New 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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":145,"type":146},50,"ESTIMATED","INTERVENTIONAL",[149],"PHASE2",[151,152],"Focal Onset Seizure","Primary Generalized Epilepsy",[151,152,154],"Tonic-Clonic","2025-03-26",{"date":157,"type":158},"2025-04-03","ACTUAL",{"date":160,"type":158},"2025-01-10",{"date":162,"type":146},"2025-07",{"name":5,"class":6},11]