[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"west-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:west-syndrome":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,70,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100449010","multicentre-real-life-follow-up-study-of-rare-epileptic-syndromes-in-children-and-adolescents-100449010",false,"NCT05126914","Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents","EPIRARE","Inclusion Criteria:\n\n* Diagnosis for rare epilepsy (based on ORPHA codes)\n* holders of parental authority not opposed\n* Be followed in one of the declared centers of the study\n\nExclusion Criteria:\n\n* opposition from the holders of parental authority or the patient","ALL","15 Years",{"count":19,"type":20},1000,"ESTIMATED","OBSERVATIONAL","Rare epilepsies as a whole account for 20-30% of epilepsies, but knowledge about prognostic factors is currently limited. This means that it is difficult to provide adequate information to families at diagnosis and during follow-up. Prognostic factors are also important for management as they can have an impact on the patient's outcome (time to intervention, choice of one molecule over another, etc.). Finally, few treatments are currently available for these epilepsies. One of the limitations to the development of treatments is the lack of real life data as it is difficult to create reliable primary endpoints such as the rate of patients becoming seizure free naturally compared to a therapeutic intervention.\n\nThe aim of this real-life study is to evaluate the response to treatment as well as to see the evolution of cognitive and psychiatric comorbidities. As explained above, there are very few randomised trials except for 3 rare epilepsies (infantile spasm syndrome, Dravet syndrome, Lennox-Gastaut syndrome). This has led to the virtual absence of management recommendations, including for the three syndromes mentioned above, where attempts at treatment algorithms have been proposed, although these have not been able to be considered as evidence-based recommendations.\n\nAs a result, there is some diversity in the management of rare epilepsies from one centre to another. However, this diversity in management can be an asset in a real-life study. This will make it possible to compare different management methods, both in terms of seizure control and medium-term outcome.",[24,25,26],"Epilepsy","West Syndrome","Dravet Syndrome","RECRUITING","2026-02-23",{"date":30,"type":31},"2026-02-24","ACTUAL",{"date":33,"type":31},"2025-12-11",{"date":35,"type":20},"2028-12",{"name":37,"class":38},"Assistance Publique - Hôpitaux de Paris","OTHER",11,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100579082","phase-2-a-study-to-prevent-infantile-spasms-relapse-100579082","NCT06819670","A Study to Prevent Infantile Spasms Relapse","A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse","Inclusion Criteria:\n\n1. Age 2 to 18 months, inclusive\n2. Clinical diagnosis of infantile spasms syndrome, with EEG-confirmed complete response to standard treatment (prednisolone, ACTH, and\u002For vigabatrin)\n\nExclusion Criteria:\n\n1. Presence of clinically significant hypertension, infection, or any other diagnosis which poses unreasonable risk in the setting of extended corticosteroid therapy, in the view of the study physician\n2. Exposure to any artisanal cannabinoid product within 14 days of screening\n3. Ongoing therapy with the ketogenic diet\n4. Implantation of a vagal nerve stimulator within 3 months of screening, or any change in stimulation parameters within 1 month of screening\n5. Treatment of IESS via epilepsy surgery","2 Months","18 Months",{"count":50,"type":20},40,"INTERVENTIONAL",[53],"PHASE2","After initially successful treatment, many children with infantile spasms unfortunately have a relapse, and relapse is linked to poor long-term outcomes such as autism and other forms of epilepsy. The aim of this study is to determine if treatment with low-dose prednisolone is safe, well tolerated, and effective in reducing the risk of relapse.",[56,57,25],"Infantile Spasms","Infantile Epileptic Spasms Syndrome",[59,56,60],"Relapse","Prednisolone","2025-05-05",{"date":63,"type":31},"2025-05-08",{"date":61,"type":31},{"date":66,"type":20},"2028-06-30",{"name":68,"class":38},"University of California, Los Angeles",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":51,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":69},"100531599","phase-2-cortical-excitability-in-west-syndrome-using-transcranial-magnetic-stimulation-100531599","NCT06201897","Cortical Excitability in West Syndrome Using Transcranial Magnetic Stimulation","Comparison of Pre- and Post- Therapy Real Time Cortical Excitability in West Syndrome Using Transcranial Magnetic Stimulation: A Longitudinal Cohort Study","Inclusion Criteria:\n\n* • Children, aged 6 months - 2 years with electroclinical diagnosis of West syndrome\n\n  * Sleep EEG available within last 1 week before screening.\n  * Screen for tuberculosis (Chest X-ray PA view and Mantoux testing) negative\n  * Parents willing for ACTH or Ketogenic Diet therapy\n\nExclusion Criteria:\n\n* Already on ACTH, prednisolone vigabatrin or KD therapy \\> 5days\n* Tuberous sclerosis\n* Vitamin trial responsiveness\n* Known Pre-existing contraindications for KD (IEM, Porphyria etc.)\n* Chronic systemic illness (Ex: Chronic kidney disease, congenital heart diseases etc)\n* Parents refusing consent for enrolment in the study.","6 Months","24 Months",{"count":50,"type":20},[53,81],"PHASE3","Currently, no literature is available regarding degree of cortical excitability and its correlation with various epileptic syndromes and disorders such as West Syndrome in pediatric age group. Studying the complex interaction of cortical excitability, seizures, neurobehavioral patterns and brain maturation in children may provide valuable information and new insights about the underlying neuropathogenic pathways in childhood epilepsy. West Syndrome is a unique epilepsy syndrome amalgamating infantile onset epilepsy with significant neurodevelopmental delay. Due to this reason, it is the ideal disorder to study this complex interaction. How cortical excitability correlates with disease activity in West Syndrome is speculative. The ability of disease characteristics such as degree of cortical excitability to predict successful outcome after ACTH therapy (non-invasive biomarker of treatment response) in children with West Syndrome has not been explored.\n\nMost importantly, the present study may be a hypothesis generating initial step bringing new insights into neurocognitive effects of seizures, seizure pathogenesis, individualized antiepileptic drug therapy and for studying treatment response.\n\nThe investigators aim to determine the change in cortical excitability pre and post ACTH therapy, in children with West syndrome and whether the change predicts responsiveness to ACTH therapy, in terms of reduction in spasm frequency at 12 weeks.",[25],"2024-03-01",{"date":86,"type":31},"2024-03-04",{"date":88,"type":20},"2024-03",{"date":90,"type":20},"2026-06",{"name":92,"class":38},"All India Institute of Medical Sciences",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":51,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":69},"100385700","vigabatrin-with-high-dose-prednisolone-combination-therapy-vs-vigabatrin-alone-for-infantile-spasm-100385700","NCT04302116","Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm","Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized Trial","Inclusion Criteria:\n\n* Age at 2-14 months at date of enrollment\n* Clinical diagnosis of infantile spasm assessed by pediatric neurologist and hypsarrhythmic pattern or variants interpreted by pediatric epileptologist\n* Thai nationality\n\nExclusion Criteria:\n\n* Previous treatment (within the last 28 days) with vigabatrin or corticosteroid\n* Previous diagnosis of epileptic encephalopathy e.g. early infantile epileptic encephalopathy and early myoclonic epileptic encephalopathy\n* Has a clinical suspicious or diagnosis of tuberous sclerosis complex characterized by one of these; known affected parent, previously diagnosed cardiac rhabdomyoma, hypomelanotic macules, forehead fibrous plaque, shagreen patch, retinal phakoma, or known polycystic kidneys\n* A contraindication to vigabatrin or corticosteroid such as recent varicella or herpes zoster infection, gastrointestinal hemorrhage etc.\n* Thai language ability of the parents or guardians is that they may not understand what is being requested of them.\n* Predictable lack of availability of follow up","14 Months",{"count":102,"type":20},250,[104],"NA","Infantile spasms (IS) are seizures associated with a severe infantile epileptic encephalopathy. Both cessation of spasms and electrographic response are necessary for the best neurodevelopmental outcomes. Adrenocorticotrophic hormone (ACTH), or prednisolone, or vigabatrin are considered the first-line treatment individually. However, ACTH expense and availability are the barriers in developing countries including Thailand. Vigabatrin, therefore, is the first recommended by Epilepsy Society of Thailand due to ACTH unavailability. Recently, combined steroid treatments (either ACTH or high dose prednisolone) with vigabatrin are superior in cessation of spasms compared to steroid treatment alone. Thus, this study is aimed to compare the efficacy of vigabatrin with high dose prednisolone combination therapy and vigabatrin alone.",[107,25],"Infantile Spasm",[107,109,60,110,25],"Vigabatrin","Treatment","2021-08-24",{"date":113,"type":31},"2021-08-25",{"date":115,"type":31},"2020-05-18",{"date":117,"type":20},"2026-12",{"name":119,"class":120},"Kullasate Sakpichaisakul","OTHER_GOV"]