[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577484":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":62,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":25,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Supernus Pharmaceuticals, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SPN-817","EXPERIMENTAL","SPN-817, bid",[13],"Drug: SPN-817",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo, bid",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","SPN-817 starting at 0.25 mg bid up to 4.00 mg bid",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":5,"role":31},"Maciej Gasior, MD, PhD","STUDY_DIRECTOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":25,"email":37},"Supernus Clinical Trials","CONTACT","240-403-5838","clinicaltrials@supernus.com",{"name":39,"role":35,"phone":40,"phoneExt":25,"email":41},"Navid Saeidi, MS","240-403-5328","nsaeidi@supernus.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Medsol Clinical Research Center","RECRUITING","Port Charlotte","Florida","33952","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-82.09064,26.97617,{"lat":55,"lon":54},[58],{"name":59,"role":35,"phone":60,"phoneExt":25,"email":61},"Maria Vasconcelos, RN","941-623-9744","mvasconcelos@medsolcrc.com",{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100577484","phase-2-renaissance-2-spn-817-phase-2-double-blind-placebo-controlled-study-in-adults-with-focal-onset-seizures-100577484",false,"NCT06798896","RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures","RENAISSANCE 2: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of SPN-817 in Adults With Focal Onset Seizures","Inclusion Criteria:\n\n1. Diagnosis of treatment-resistant focal epilepsy as adjudicated by the Epilepsy Study Consortium, Inc (ESCI);\n2. Failed to achieve sustained seizure freedom after ≥2 tolerated, appropriately chosen, and adequately dosed ASM drug schedules;\n3. Able to keep accurate Seizure electronic diaries \\[eDiaries\\] (with the aid of a caregiver as needed);\n4. Has a body mass index (BMI) between 18.0 and 40.0 kg\u002Fm2;\n5. Treatment with a stable dose of 1 to 4 current ASMs for ≥28 days prior to screening. If following a diet plan along with the ASM, the participant should have been on a stable diet plan for at least 1 month prior to Visit 1. The diet plan should be maintained throughout the duration of the study;\n6. At least 4 clinically observable focal onset seizures accepted by the ESCI prior to the first dose of SM (during the days of baseline Seizure electronic diary \\[eDiary\\] data collection) and no more than a consecutive 21-day period that was free of these seizures. To be eligible for the study, participants must comply with the eDiary on at least 80% of the days of baseline data collection;\n\nExclusion Criteria:\n\n1. Has taken huperzine A within the past 6 months;\n2. Prior diagnosis of combined focal and generalized epilepsy syndrome as evidenced by severe developmental delay and multiple seizure types and confirmed by electroencephalography (EEG) (eg, Lennox-Gastaut syndrome). Participants should also be excluded in case of nondiagnostic information;\n3. History of or current nonepileptic events that could be confused by the participant and\u002For study staff as epileptic seizures;\n4. Only has seizures that are difficult to count; for example, seizures that are not clinically observable;\n5. History of uncountable seizures, such as seizures that happen in a cluster that are too rapid to be counted individually;\n6. History of status epilepticus within 6 months prior to screening;\n7. Vagus nerve stimulation, deep brain stimulation, responsive neurostimulator system, or other neurostimulation for epilepsy device implanted or activated within 1 year prior to screening; or epilepsy surgery within 1 year prior to screening. Stimulation parameters for devices must have been stable for at least 3 months prior to Screening. Battery change for any epilepsy devices will be allowed; however, stimulation parameters must remain stable during the duration of the study;\n8. Any suicidal behavior or suicidal ideation related to item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS assessment in the 1 year before screening; a suicide attempt in the last 2 years before screening; or more than 1 lifetime suicide attempt;\n9. Chronic concomitant therapy with non-ASMs that have potent cholinergic (central or peripheral) or potent central (only) anticholinergic pharmacology.\n10. History of \\>2 allergic reactions to an ASM or 1 serious hypersensitivity reaction to an ASM;\n11. Any other reason which, in the opinion of the Investigator, would prevent the participant from taking part in the study.","ALL","18 Years","70 Years",{"count":75,"type":76},216,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy, safety, and tolerability of SPN-817 in adults with focal onset seizures.",[82],"Focal Onset Seizures",[84,85,86,87],"focal seizures","focal epilepsy","Phase 2","anti-seizure medication","2026-05-28",{"date":90,"type":91},"2026-06-01","ACTUAL",{"date":93,"type":91},"2024-12-30",{"date":95,"type":76},"2027-08",{"name":5,"class":6},1]