[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06798896":3,"trial-entities:NCT06798896":105,"trial-summary:NCT06798896":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":42,"secondary_outcomes":47,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":15,"eligibility_criteria":67,"std_ages":71,"locations":74,"central_contacts":90,"overall_officials":99,"references":103,"see_also_links":104},"NCT06798896","817P203","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","RECRUITING","2027-08","2026-05","2026-06-01","2024-12-30","Supernus Pharmaceuticals, Inc.","INDUSTRY",false,"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.","This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy, safety, and tolerability of SPN-817 administered as an adjunctive treatment in adults with focal onset seizures that have previously failed at least 2 anti-seizure medication (ASM) regimens. Participants will be taking 1 to 4 ASMs, with at least 4 seizures during the 6-week Screening Period. Following the Screening Period, eligible participants will be randomized 2:1 to SPN-817 (3.0-4.0 mg BID) or placebo and begin the Titration Period (8-10 weeks). In both treatment groups, open-label ondansetron (or another concomitant medication to assess pharmacological approaches to managing cholinergic adverse events \\[AEs\\]) will be taken (8 mg oral \\[PO\\]) prophylactically approximately 30 minutes before each study medication (SM) dose (ie, BID) during the Titration Period as an antiemetic. After the target dose of 3.0-4.0 mg BID is reached, participants will enter the Maintenance Period (14 weeks). Ondansetron (or another concomitant medication to assess pharmacological approaches to managing cholinergic AEs) may be taken as needed as either a preventative or therapeutic antiemetic during the Maintenance Period. Participants who complete the Maintenance Period will have the opportunity to enroll in a separate open-label study for continued treatment with SPN-817. Participants who do not enroll in the open-label study will undergo a Tapering Period (up to 4 weeks) and a follow-up safety phone call.",[19],"Focal Onset Seizures",[21,22,23,24],"focal seizures","focal epilepsy","Phase 2","anti-seizure medication","INTERVENTIONAL","TREATMENT",[28],"PHASE2",{"count":30,"type":31},216,"ESTIMATED",[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","SPN-817","SPN-817 starting at 0.25 mg bid up to 4.00 mg bid",[35],{"type":34,"name":39,"description":40,"armGroupLabels":41},"Placebo","Placebo, bid",[39],[43],{"measure":44,"description":45,"timeFrame":46},"Percent change (PCH) from baseline in focal onset seizure frequency per 28 days over the Maintenance Period","Percent change in 28-day frequency of focal seizures during the 14 week Maintenance Period relative to baseline","Baseline and Maintenance Period (Maintenance Week 1-14)",[48,51,55,57,60],{"measure":49,"description":50,"timeFrame":46},"Proportion of subjects experiencing ≥50% reduction in focal seizure frequency per 28 days from baseline","Greater than or equal to 50% reduction in 28-day frequency of focal seizures during the 14 week Maintenance Period relative to baseline.",{"measure":52,"description":53,"timeFrame":54},"PCH from baseline in focal onset seizure frequency per 28 days over the entire Treatment Period","Percent change in 28-day frequency of focal seizures during the entire Treatment Period (Titration Period + Maintenance Period) relative to baseline","Baseline through Titration Week 1 up to Week 10 and Maintenance Weeks 1-14",{"measure":49,"description":56,"timeFrame":54},"Greater than or equal to 50% reduction in 28-day frequency of focal seizures during the Treatment Period (Titration Period + Maintenance Period) relative to baseline.",{"measure":58,"description":59,"timeFrame":54},"Longest seizure-free interval over the entire Treatment Period","The longest intervals in days between two seizures during the entire Treatment Period.",{"measure":61,"description":62,"timeFrame":63},"Incidence of treatment-emergent adverse events (TEAEs)","The percent of subjects who took at least one dose of SPN-817 and reported at least one adverse event during SPN-817 treatment.","Baseline through Titration Week 1 up to Week 10, Maintenance Weeks 1-14, and Tapering Period up to Week 4","ALL","18 Years","70 Years",{"inclusion":68,"exclusion":69,"raw_text":70},[],[],"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.",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":87},"Medsol Clinical Research Center","Port Charlotte","Florida","33952","United States",[82],{"name":83,"role":84,"phone":85,"email":86},"Maria Vasconcelos, RN","CONTACT","941-623-9744","mvasconcelos@medsolcrc.com",{"lat":88,"lon":89},26.97617,-82.09064,[91,95],{"name":92,"role":84,"phone":93,"email":94},"Supernus Clinical Trials","240-403-5838","clinicaltrials@supernus.com",{"name":96,"role":84,"phone":97,"email":98},"Navid Saeidi, MS","240-403-5328","nsaeidi@supernus.com",[100],{"name":101,"affiliation":13,"role":102},"Maciej Gasior, MD, PhD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":106,"biomarkers":109},[107,108],"Partial Epilepsy","Partial Seizure",[],{"nct_id":4,"found":111,"summary":112,"prompt_version":122},true,{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is a Phase 2, double-blind (you and your doctor won't know if you're getting the study drug or placebo), randomized study. About 216 adults will participate, with some receiving SPN-817 and others receiving a placebo.","completed","Phase 2 Study of SPN-817 for Focal Onset Seizures","This study is testing a drug called SPN-817 for adults with focal onset seizures (seizures that start in one area of the brain). You might be able to join if you are between 18 and 70 years old, have been diagnosed with treatment-resistant focal epilepsy, and have tried at least two other seizure medications without success. The main goal is to see how much SPN-817 can reduce the number of focal onset seizures you have over 28 days, compared to a placebo (an inactive substance). The study is currently unclear about its recruitment status and plans to enroll 216 participants.","Participants who complete the 14-week Maintenance Period may have the opportunity to enroll in a separate open-label study for continued treatment.",100,"You would take SPN-817 or placebo twice a day, starting with a lower dose and gradually increasing it over 8-10 weeks. This would be followed by a 14-week maintenance period. You would also need to keep accurate electronic diaries of your seizures.","Not stated in the trial record.",[35,39],null]