[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543196":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":46,"collaborators":19,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":19,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":73,"whyStopped":19,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cenobamate","EXPERIMENTAL","400mg load plus 100mg a day for maximum of 14 days",[13],"Drug: Cenobamate",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Study Drug: Cenobamate 400mg x 1 NGT\u002FG-tube (Day 1), 100mg (Day 2-14)\n\n* Discontinued cenobamate upon cessation of seizures or RegiSCAR score 4-5 or at 14 days.\n* Adjust cenobamate dose based on patient response; this may include discontinuation if seizures resolve, or increase in dose to 150mg or 200mg a day after Day 7",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Jong Woo Lee, MD, PhD","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","617-732-7547","jlee38@bwh.harvard.edu",{"name":30,"role":26,"phone":31,"phoneExt":19,"email":32},"Melanie Choe, BA","617-525-3014","mlchoe@bwh.harvard.edu",[34],{"facility":5,"status":19,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":19},"Boston","Massachusetts","02115","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-71.05977,42.35843,{"lat":44,"lon":43},{"type":23,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Jong Woo Lee","Principal Investigator","100543196","early-phase-1-cenobamate-in-the-intensive-care-unit-100543196",false,"NCT06352723","Cenobamate in the Intensive Care Unit","Use of Cenobamate in the Intensive Care Unit for Acute Frequent Seizures and Status Epilepticus","CENOBITE","Inclusion Criteria:\n\n* Age 18-70.\n* Undergoing EEG monitoring.\n* Acute frequent seizures (\\>1\u002Fhour) or status epilepticus (\\>5 min of consecutive seizures, or seizure burden \\>20% within past 1 hour).\n* Adjunctive conventional antiseizure medication indicated.\n\nExclusion Criteria:\n\n* History of medication-related rash.\n* On medication or device affecting enteral absorption (e.g., phenobarbital, pentobarbital).\n* Counterindication to cenobamate as described in the prescribing information.",true,"ALL","18 Years","70 Years",{"count":62,"type":63},10,"ESTIMATED","INTERVENTIONAL",[66],"EARLY_PHASE1","The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH.\n\nMonitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome.",[69,70],"Epilepsy","Neurologic Disorder",[72],"ICU","NOT_YET_RECRUITING","2026-03-25",{"date":76,"type":77},"2026-03-30","ACTUAL",{"date":79,"type":63},"2026-06",{"date":81,"type":63},"2029-06",{"name":5,"class":6},1]