[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648530":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":33,"locations":39,"responsibleParty":132,"collaborators":30,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":30,"eligibilityCriteria":140,"healthyVolunteers":136,"sex":141,"minAge":142,"maxAge":30,"enrollmentInfo":143,"targetDuration":30,"studyType":146,"phases":147,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":156,"whyStopped":30,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Jazz Pharmaceuticals","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"JZP926 Capsule","EXPERIMENTAL","Participants with JME will be randomized to JZP926 capsule based on weight-tiered dosing for a 16-week treatment period.",[13],"Drug: JZP926 capsule",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants with JME will be randomized to matching placebo based on weight-tiered dosing for a 16-week treatment period.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Open-Label Extension: JZP926 Capsule","Participants completing Part A or Part B will have the option to continue into an open-label extension for up to 52 weeks, inclusive of a 4 week blinded transition.",[13],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","JZP926 capsule","Oral administration BID according to body weight",[9,21],null,{"type":26,"name":15,"description":28,"armGroupLabels":32,"otherNames":30},[15],[34],{"name":35,"role":36,"phone":37,"phoneExt":30,"email":38},"Clinical Trial Disclosure & Transparency","CONTACT","215-832-3750","ClinicalTrialDisclosure@JazzPharma.com",[40,53,62,71,79,88,97,106,115,124],{"facility":41,"status":30,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":30},"Clinical Trial Site","New Haven","Connecticut","06510","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-72.92816,41.30815,{"lat":51,"lon":50},{"facility":41,"status":30,"city":54,"state":55,"zip":56,"country":45,"countryCode":46,"cosmosGeoPoint":57,"geoPoint":61,"contacts":30},"Tampa","Florida","33609",{"type":48,"coordinates":58},[59,60],-82.45843,27.94752,{"lat":60,"lon":59},{"facility":41,"status":30,"city":63,"state":64,"zip":65,"country":45,"countryCode":46,"cosmosGeoPoint":66,"geoPoint":70,"contacts":30},"Atlanta","Georgia","30329",{"type":48,"coordinates":67},[68,69],-84.38798,33.749,{"lat":69,"lon":68},{"facility":41,"status":30,"city":72,"state":64,"zip":73,"country":45,"countryCode":46,"cosmosGeoPoint":74,"geoPoint":78,"contacts":30},"Savannah","31406",{"type":48,"coordinates":75},[76,77],-81.09983,32.08354,{"lat":77,"lon":76},{"facility":41,"status":30,"city":80,"state":81,"zip":82,"country":45,"countryCode":46,"cosmosGeoPoint":83,"geoPoint":87,"contacts":30},"Honolulu","Hawaii","96817",{"type":48,"coordinates":84},[85,86],-157.85833,21.30694,{"lat":86,"lon":85},{"facility":41,"status":30,"city":89,"state":90,"zip":91,"country":45,"countryCode":46,"cosmosGeoPoint":92,"geoPoint":96,"contacts":30},"Hawthorne","New York","10532",{"type":48,"coordinates":93},[94,95],-73.79597,41.10732,{"lat":95,"lon":94},{"facility":41,"status":30,"city":98,"state":99,"zip":100,"country":45,"countryCode":46,"cosmosGeoPoint":101,"geoPoint":105,"contacts":30},"Cincinnati","Ohio","45229",{"type":48,"coordinates":102},[103,104],-84.51439,39.12711,{"lat":104,"lon":103},{"facility":41,"status":30,"city":107,"state":108,"zip":109,"country":45,"countryCode":46,"cosmosGeoPoint":110,"geoPoint":114,"contacts":30},"Portland","Oregon","97239",{"type":48,"coordinates":111},[112,113],-122.67621,45.52345,{"lat":113,"lon":112},{"facility":41,"status":30,"city":116,"state":117,"zip":118,"country":45,"countryCode":46,"cosmosGeoPoint":119,"geoPoint":123,"contacts":30},"Roanoke","Virginia","24016",{"type":48,"coordinates":120},[121,122],-79.94143,37.27097,{"lat":122,"lon":121},{"facility":41,"status":30,"city":125,"state":117,"zip":126,"country":45,"countryCode":46,"cosmosGeoPoint":127,"geoPoint":131,"contacts":30},"Winchester","22601",{"type":48,"coordinates":128},[129,130],-78.16333,39.18566,{"lat":130,"lon":129},{"type":133,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100648530","phase-2-a-study-to-evaluate-the-safety-and-efficacy-of-jzp926-capsule-for-the-treatment-of-juvenile-myoclonic-epilepsy-100648530",false,"NCT07723963","A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy","A Phase 2\u002F3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of JZP926 in Participants Aged 10 Years and Older for the Treatment of Juvenile Myoclonic Epilepsy","Inclusion Criteria\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Is ≥ 10 years of age at the time of screening.\n2. Has a diagnosis of JME per ILAE criteria as specified in the protocol.\n3. Has at least 4 myoclonic seizure days per 28 days historical seizure frequency.\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Presence of seizure types other than GTC, myoclonic, and absence seizures.\n2. If historical MRI has been performed, participant's MRI reveals a cause of epilepsy other than JME.\n3. Has a concurrent, confirmed diagnosis of non-epileptic seizures or events that can confound the assessment of the efficacy measures, in the opinion of the investigator.\n4. The etiology of the participant's seizures is a progressive neurologic disease.\n5. Has clinically unstable or progressive epilepsy.\n6. Has clinically significant unstable medical condition(s), other than epilepsy, including unstable psychiatric disorders.\n7. Has a history of status epilepticus in the 3 months prior to screening.\n8. History of suicidal behavior, current suicidal risk as determined from history, or presence of active suicidal ideation as indicated by a positive response to Item 4 or Item 5 on the C-SSRS or is considered at risk of suicide or self-harm based on the clinical judgement of the investigator following interview with the participant and\u002For caregiver.\n9. Has known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention.\n10. Is currently treated with Epidiolex or recently received treatment with Epidiolex within 28 days prior to screening.\n11. Has a body weight \\\u003C 20 kg or \\> 150 kg.\n12. Is currently using or has used recreational or medicinal cannabis, cannabinoid\u002FCBD based medications, products, or supplements (botanical or synthetic) within 28 days prior to screening.\n13. Is unwilling or unable to abstain from recreational or medicinal cannabis, cannabinoid\u002FCBD based medications, products, or supplements (botanical or synthetic) for the duration of the study.","ALL","10 Years",{"count":144,"type":145},260,"ESTIMATED","INTERVENTIONAL",[148,149],"PHASE2","PHASE3","This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).",[152],"Juvenile Myoclonic Epilepsy",[154,155,27],"Juvenile myoclonic epilepsy","JME","NOT_YET_RECRUITING","2026-07-22",{"date":159,"type":160},"2026-07-24","ACTUAL",{"date":162,"type":145},"2026-09-01",{"date":164,"type":145},"2028-08-01",{"name":5,"class":6},10]