[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"electrical-status-epilepticus-in-sleep\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:electrical-status-epilepticus-in-sleep":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100610006","phase-2-melatonin-for-the-treatment-of-dee-swas-100610006",false,"NCT07221968","Melatonin for the Treatment of DEE-SWAS","Melatonin for the Treatment of Developmental\u002FEpileptic Encephalopathy With Spike Wave Activation In Sleep (DEE-SWAS; Formerly ESES)","Inclusion Criteria:\n\nClinic Dx of DEE-SWAS\n\n1. Dx of DEE-SWAS by a board-certified pediatric neurology\u002Fepileptologist Clinical history of delayed milestones in at least 1 category, regression of milestones in at least 1 category, and\u002For failure to progress in milestones in at least 1 category\n2. Abnormal baseline neuropsychiatric testing consistent with Dx Abnormal EEG\n3. Epileptiform abnormalities (spike, polyspike, sharp) in at least 1 head region\n4. Increase by 2-fold of epileptiform abnormalities during NREM sleep as compared to wakefulness\n5. SWI of ≥50% in at least one head region on overnight EEG\n\nExclusion Criteria:\n\n1. Allergic to ingredients in study drug Melatonin\n\n   * Hypoallergenic plant fiber (cellulose)\n   * Active use of the medication viloxazine\n2. History of known cardiac rhythm abnormalities, heart failure or decreased EF \\\u003C30%\n3. History of known pulm requiring oxygen or invasive positive pressure ventilation. Patients with non-invasive PPV (e.g. CPAP) due OSA w\u002Fo 02 requirement, rate, or DX of CSA, on stable pressure settings for \\>3 mnths will not be excluded.\n4. History of liver dysf OR AST\u002FALT\u002FAlkPhos \\>2.5 ULN w\u002Fi year. If lab value meeting exclusion between 3-12 months, a repeat lab value \\\u003C 2.5 ULN will be considered for inclusion\n5. Post-menarchal participants. of childbearing potential with a positive urine pregnancy test","ALL","5 Years","17 Years",{"count":20,"type":21},3,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this study is to learn if melatonin, a naturally produced substance, can help to treat some of the symptoms of DEE-SWAS, a type of epilepsy that causes children to lose skills and development. It will look at doses of melatonin that are higher than most people use.\n\nThe study will look at the safety of melatonin in patients with DEE-SWAS The study will look at the ways melatonin affects abnormal brain activity on a study called an EEG.\n\nThe study will look at the ways melatonin affects normal brain activity that occurs in sleep.",[27,28,29],"CSWS","Developmental and\u002For Epileptic Encephalopathies","Electrical Status Epilepticus in Sleep",[31,32,27,33,34],"DEE-SWAS","ESES","epileptic encephalopathy","melatonin","NOT_YET_RECRUITING","2025-10-28",{"date":38,"type":39},"2025-10-30","ACTUAL",{"date":41,"type":21},"2026-07-01",{"date":43,"type":21},"2028-12-30",{"name":45,"class":46},"Hugo W. Moser Research Institute at Kennedy Krieger, Inc.","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100576984","study-of-patients-with-electrical-status-epilepticus-in-sleep-100576984","NCT06792396","Study of Patients with Electrical Status Epilepticus in Sleep","Study to Understand the Diagnostic Measures, Management Options and Long Term Outcomes in a Local Cohort of Patients with Electrical Status Epilepticus in Sleep, Also Known As a Developmental And\u002For Epileptic Encephalopathy with Spike-Wave Activation in Sleep","SPESES","Inclusion Criteria:\n\n1. Any Paediatric patient (up to 16 years old) who has been managed for electrical status epilepticus in sleep or developmental and\u002For epileptic encephalopathy with spike-wave activation in sleep, by clinicians at East Suffolk and North Essex NHS Foundation Trust, within the last 15 years.\n2. Patients meeting criteria 1) with available electronic health records.\n\nExclusion Criteria:\n\n1. Any Paediatric patient (up to 16 years old) with epilepsy managed by clinicians at East Suffolk and North Essex NHS Foundation Trust, where the diagnosis of electrical status epilepticus in sleep or developmental and\u002For epileptic encephalopathy with spike-wave activation in sleep was not confirmed.\n2. Patients without electronic health record availability.\n3. Patients over 16 years old.\n4. Patients who have opted out of data use as per national opt out policy.","1 Year","16 Years",{"count":58,"type":21},20,"OBSERVATIONAL","Our aims are:\n\n1. To understand the diagnostic practices, treatment and long term management and outcomes for patients diagnosed with ESES locally.\n2. To establish a regional and national guideline for the diagnosis and management of patients with ESES.\n\nThe secondary questions that can be addressed with this case series review include the variability of clinical care given to patients with this condition, and for example, the duration of time it takes to obtain diagnostic tests and assessments by psychologists.",[29],"RECRUITING","2025-01-20",{"date":65,"type":39},"2025-01-24",{"date":67,"type":39},"2024-08-12",{"date":69,"type":21},"2025-03",{"name":71,"class":46},"East Suffolk and North Essex NHS Foundation Trust",1]