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Upon the completion of Treatment Period 1 all eligible patients, will enter Treatment Period 2 and receive zorevunersen, regardless of initial treatment assignment.",[13],"Drug: zorevunersen",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Comparator","SHAM_COMPARATOR","Eligible patients will be randomly assigned in a 1:1 ratio to zorevunersen:sham",[19],"Other: Sham Comparator",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","zorevunersen","Treatment Period 1: Zorevunersen group will receive study drug by intrathecal (IT) administration on Day 1 (after the 8-week Baseline Period), Day 57 (Week 8), Day 169 (Week 24), and Day 281 (Week 40) at a dose level of 70 mg on Day 1 and Day 57, and 45 mg on Day 169 and Day 281.\n\nTreatment Period 2: Group assigned to zorevunersen in Treatment Period 1 will receive 45 mg of zorevunersen on Day 393 (Week 56), Day 477 (Week 68), and Day 589 (Week 84).",[9],null,{"type":28,"name":15,"description":29,"armGroupLabels":30,"otherNames":26},"OTHER","Treatment Period 1: Sham group will not have drug administered. 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Study Evaluating the Efficacy, Safety, and Tolerability of Zorevunersen in Patients With Dravet Syndrome","EMPEROR: A Multicenter, Randomized, Double-blind, Sham-controlled, Parallel Group, Phase 3 Study Evaluating the Efficacy, Safety, and Tolerability of Zorevunersen (STK-001) in Patients With Dravet Syndrome","Key Inclusion Criteria:\n\n1. Patients must be ≥2 and \\\u003C18 years of age.\n2. Patients must have a clinical diagnosis of DS confirmed by the Epilepsy Study Consortium, Inc. (ESCI) and as defined by:\n\n   Onset, prior to 12 months (inclusive, \\\u003C13 months), of age, of recurrent focal with motor signs, hemiclonic, or generalized tonic-clonic seizures. No other known etiology causing clinical DS manifestations..\n3. Patient must have a documented pathogenic, likely pathogenic variant, or variant of uncertain significance in the sodium voltage-gated channel type 1 alpha subunit (SCN1A) gene. Patients who have SCN1A testing results of Negative (no variants identified) cannot be randomized.\n4. Patient must experience the required number of major motor seizures during the 6-week Observation Period. Major motor seizure types included are Seizure types included in counts are Hemiclonic, Focal with Motor Signs, Focal to Bilateral Tonic-Clonic, Generalized Tonic-Clonic, Tonic, Tonic\u002FAtonic (Drop Attacks with fall or risk of fall), and Bilateral Clonic.\n5. Patient must have used at least 2 prior interventions for seizures. These can include anti-seizure medications (ASMs), ketogenic diet and\u002For vagus nerve stimulation (VNS) with either lack of adequate seizure control or discontinued due to an AE(s). These interventions can be ongoing therapies.\n6. Patient must be taking at least one ASM. Benzodiazepines or ASMs used on a standing basis (i.e., not as needed \\[PRN\\]) for any indication will be considered an ASM.\n7. Patients' maintenance ASMs and interventions for seizures (i.e., ketogenic diet or VNS), as well as any marijuana- or cannabinoid-based products, must have been stable (unless adjusted for weight) during the Baseline Period.\n\nKey Exclusion Criteria:\n\n1. Patient has documented variant in the SCN1A gene associated with gain-of-function\n2. Patient is currently treated with a maintenance ASM acting primarily as a sodium channel blocker, including but not limited to phenytoin, carbamazepine, oxcarbazepine, lamotrigine, lacosamide, rufinamide, or cenobamate, given the mechanism of action of zorevunersen.\n3. Patient is currently treated with neuromodulation techniques (e.g., responsive neurostimulation, deep brain stimulation, or transcranial magnetic stimulation), with the exception of VNS.\n4. Patient has emergence of a new seizure type or reemergence of a past seizure type (seizure types that last occurred more than 12 months before Screening Visit A) during the Baseline Period, or has more than 1 hospitalization for seizures during the Baseline Period.","ALL","2 Years","17 Years",{"count":593,"type":594},170,"ESTIMATED","INTERVENTIONAL",[597],"PHASE3","The purpose of the study is to evaluate the efficacy, safety, and tolerability of zorevunersen in Patients with Dravet syndrome.",[600],"Dravet Syndrome",[602,603,604,605,606],"Pediatric epilepsy","Epileptic Encephalopathies","Refractory Myoclonic Epilepsy","Severe Myoclonic Epilepsy in Infancy","STK-001","2026-06-30",{"date":609,"type":610},"2026-07-01","ACTUAL",{"date":612,"type":610},"2025-06-04",{"date":614,"type":594},"2028-10",{"name":5,"class":6},58]