[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566607":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":11,"studyPopulation":20,"armGroups":21,"interventions":26,"overallOfficials":11,"centralContacts":32,"locations":38,"responsibleParty":51,"collaborators":11,"id":53,"slug":11,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":11,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":11,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},{"fullName":5,"class":6},"Eisai Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Number of Participants with Adverse Drug Reactions (ADRs) and Adverse Events (AEs)",null,"Up to 4 weeks",{"measure":14,"description":11,"timeFrame":12},"Number of Participants With ADRs Based on Participant Characteristic",{"measure":16,"description":11,"timeFrame":12},"Plasma Concentration of Fycompa in Children Aged Greater Than or Equal to (>=) 4 Years and Less than (\u003C) 12 Years",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":18,"timePerspective":19,"maskingInfo":11},"COHORT","PROSPECTIVE","Participants with epilepsy who received the Fycompa for injection for the first time will be included.",[22],{"label":23,"type":11,"description":11,"interventionNames":24},"Fycompa",[25],"Other: No Intervention",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"OTHER","No Intervention","This is a non-interventional study.",[23],[33],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Eisai Inquiry Service","CONTACT","0120-419-497","eisai-chiken_hotline@hhc.eisai.co.jp",[39],{"facility":40,"status":41,"city":42,"state":11,"zip":11,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":11},"1","RECRUITING","Tokyo","Japan","JP",{"type":46,"coordinates":47},"Point",[48,49],139.69171,35.6895,{"lat":49,"lon":48},{"type":52,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100566607",false,"NCT06657378","A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic Seizures","A Multicenter, Postmarketing Observational (Noninterventional) Study to Evaluate the Safety of Fycompa for Injection in Patients With Partial-Onset Seizures (Including Secondarily Generalized Seizures) (Age 4 Years or Older) or Primary Generalized Tonic- Clonic Seizures (Age 12 Years or Older)","Inclusion Criteria:\n\n* Participants with epilepsy who received the Fycompa for injection for the first time will be included.\n\nExclusion Criteria:\n\n* The exclusion criteria will not be specified in particular because this survey will be conducted in daily clinical practice.","ALL","4 Years",{"count":62,"type":63},110,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to determine the safety of Fycompa for injection after administration in participants with epilepsy (partial-onset seizures \\[including secondarily generalized seizures\\]) (age 4 years or older) or primary generalized tonic-clonic seizures (age 12 years or older).",[67,68],"Partial-Onset Seizures","Primary Generalized Tonic-clonic Seizures",[70,71,23],"Seizures","Secondarily Generalized Seizures","2026-06-30",{"date":74,"type":75},"2026-07-01","ACTUAL",{"date":77,"type":75},"2024-11-18",{"date":79,"type":63},"2028-06-15",{"name":81,"class":6},"Eisai Co., Ltd.",1]