[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100385700":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":75,"collaborators":41,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":41,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":41,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":48,"whyStopped":41,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Queen Sirikit National Institute of Child Health","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Combination therapy with vigabatrin and prednisolone","EXPERIMENTAL","Vigabatrin (tablet of 500 mg) dose based on weight divided in two times. The protocol for vigabatrin dose is 50 mg\u002Fkg\u002Fday at Day 1, 100 mg\u002Fkg\u002Fday at Day 2, and increase to 150 mg\u002Fkg\u002Fday if seizures still occur after 72 hours after treatment. Vigabatrin will be continued for 3 months, then reduced and completely off within 4 weeks.\n\nPrednisolone (tablet of 5 mg), 40 mg of prednisolone (10 mg oral 4 times a day) for 14 days. Prednisolone will be increased to 60 mg\u002Fday (20 mg oral 3 times a day) if seizures still occur at Day 7 or recur within Day 8 - 14. Then, prednisolone will be reduced every 5 day until completely off within 1 month. Total prednisolone duration is 1 month.",[13],"Drug: Combination therapy with vigabatrin and prednisolone",{"label":15,"type":16,"description":17,"interventionNames":18},"Vigabatrin alone","ACTIVE_COMPARATOR","Vigabatrin (500 mg\u002Ftab) dose will be calculated on weight basis divided in two times. The protocol for vigabatrin dose is 50 mg\u002Fkg\u002Fday at Day 1, 100 mg\u002Fkg\u002Fday at Day 2, and increase to 150 mg\u002Fkg\u002Fday if seizures still occur after 72 hours after treatment.\n\nVigabatrin will be continued for 3 months, then reduced and completely off within 4 weeks.",[19],"Drug: Vigabatrin Tablets",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","High dose prednisolone (40 - 60 mg\u002Fday) for 1 month combined with vigabatrin treatment (50-150 mg\u002Fkg\u002Fday) twice daily for 4 months",[9],[26],"Sabril with prednisolone",{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Vigabatrin Tablets","Vigabatrin (50-150 mg\u002Fkg\u002Fday) twice daily for 4 months",[15],[32],"Sabril",[34],{"name":35,"affiliation":5,"role":36},"Kullasate Sakpichaisakul, MD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","66-2-354-8333",null,"kullasate.s@rsu.ac.th",{"name":44,"role":39,"phone":40,"phoneExt":41,"email":45},"Sirorat Suwannachote, MD","sirorat.s@rsu.ac.th",[47],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Ratchathewi","Bangkok","10400","Thailand","TH",{"type":55,"coordinates":56},"Point",[57,58],100.53358,13.759,{"lat":58,"lon":57},[61,62,65,66,68,70,71,73],{"name":35,"role":39,"phone":41,"phoneExt":41,"email":42},{"name":63,"role":39,"phone":41,"phoneExt":41,"email":64},"Kantapon Trongkamolchai, MD","kantapon260619870@gmail.com",{"name":35,"role":36,"phone":41,"phoneExt":41,"email":41},{"name":63,"role":67,"phone":41,"phoneExt":41,"email":41},"SUB_INVESTIGATOR",{"name":69,"role":67,"phone":41,"phoneExt":41,"email":41},"Somjit Sri-udomkajorn, MD",{"name":44,"role":67,"phone":41,"phoneExt":41,"email":41},{"name":72,"role":67,"phone":41,"phoneExt":41,"email":41},"Ravivan Wittawassamrankul, R Ph",{"name":74,"role":67,"phone":41,"phoneExt":41,"email":41},"Ravindra Arya, MD, DM",{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Kullasate Sakpichaisakul","Pediatric epileptologist","100385700","vigabatrin-with-high-dose-prednisolone-combination-therapy-vs-vigabatrin-alone-for-infantile-spasm-100385700",false,"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","ALL","2 Months","14 Months",{"count":90,"type":91},250,"ESTIMATED","INTERVENTIONAL",[94],"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.",[97,98],"Infantile Spasm","West Syndrome",[97,100,101,102,98],"Vigabatrin","Prednisolone","Treatment","2021-08-24",{"date":105,"type":106},"2021-08-25","ACTUAL",{"date":108,"type":106},"2020-05-18",{"date":110,"type":91},"2026-12",{"name":77,"class":6},1]