[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07723963":3,"trial-entities:NCT07723963":158,"trial-summary:NCT07723963":161},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":29,"interventions":32,"primary_outcomes":42,"secondary_outcomes":46,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":74,"locations":78,"central_contacts":149,"overall_officials":155,"references":156,"see_also_links":157},"NCT07723963","JZP926-203","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","NOT_YET_RECRUITING","2028-08-01","2026-07","2026-07-24","2026-09-01","Jazz Pharmaceuticals","INDUSTRY",true,"This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).","This Phase 2\u002F3 multicenter, randomized, placebo-controlled, double-blind study will evaluate the safety and efficacy of JZP926 capsule in participants aged ≥ 10 years with Juvenile Myoclonic Epilepsy (JME). The study will assess the efficacy of JZP926 capsule as an adjunctive treatment in reducing the frequency of myoclonic seizure days when compared with placebo, as well as the effect of JZP926 capsule on non-seizure endpoints.",[19],"Juvenile Myoclonic Epilepsy",[21,22,23],"Juvenile myoclonic epilepsy","JME","JZP926 capsule","INTERVENTIONAL","TREATMENT",[27,28],"PHASE2","PHASE3",{"count":30,"type":31},260,"ESTIMATED",[33,39],{"type":34,"name":23,"description":35,"armGroupLabels":36},"DRUG","Oral administration BID according to body weight",[37,38],"JZP926 Capsule","Open-Label Extension: JZP926 Capsule",{"type":34,"name":40,"description":35,"armGroupLabels":41},"Placebo",[40],[43],{"measure":44,"timeFrame":45},"Change from baseline in myoclonic seizure days per 28 days (Part A and Part B)","Baseline up to end of 16 weeks treatment period",[47,50,52,54,56,58,60,62,64],{"measure":48,"timeFrame":49},"Patient and Caregiver Global Impression of Change in Usual Daily Activities (P\u002FCaGI-C UDA) (Part A and Part B)","Week 16",{"measure":51,"timeFrame":45},"Proportion of participants who achieve ≥ 50% and ≥ 75% reduction from baseline in myoclonic seizure days (Part A and Part B)",{"measure":53,"timeFrame":45},"Change from baseline in days with any seizure type per 28 days (Part A and Part B)",{"measure":55,"timeFrame":45},"Number of days with fewer myoclonic seizures than participant average prior to entering the study per 28 days (Part A and Part B)",{"measure":57,"timeFrame":45},"Percent change from baseline (historical + prospective) in generalized tonic-clonic (GTC) seizure frequency (Part A and Part B)",{"measure":59,"timeFrame":45},"Number of participants reporting treatment-emergent adverse events (Part A and Part B)",{"measure":61,"timeFrame":45},"Mean plasma concentration for CBD",{"measure":63,"timeFrame":45},"Mean plasma concentration of metabolite 7-OH-CBD",{"measure":65,"timeFrame":45},"Mean plasma concentration of metabolite 7-COOH-CBD","ALL","10 Years",null,false,{"inclusion":71,"exclusion":72,"raw_text":73},[],[],"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.",[75,76,77],"CHILD","ADULT","OLDER_ADULT",[79,88,95,102,108,115,122,129,136,143],{"facility":80,"city":81,"state":82,"zip":83,"country":84,"geoPoint":85},"Clinical Trial Site","New Haven","Connecticut","06510","United States",{"lat":86,"lon":87},41.30815,-72.92816,{"facility":80,"city":89,"state":90,"zip":91,"country":84,"geoPoint":92},"Tampa","Florida","33609",{"lat":93,"lon":94},27.94752,-82.45843,{"facility":80,"city":96,"state":97,"zip":98,"country":84,"geoPoint":99},"Atlanta","Georgia","30329",{"lat":100,"lon":101},33.749,-84.38798,{"facility":80,"city":103,"state":97,"zip":104,"country":84,"geoPoint":105},"Savannah","31406",{"lat":106,"lon":107},32.08354,-81.09983,{"facility":80,"city":109,"state":110,"zip":111,"country":84,"geoPoint":112},"Honolulu","Hawaii","96817",{"lat":113,"lon":114},21.30694,-157.85833,{"facility":80,"city":116,"state":117,"zip":118,"country":84,"geoPoint":119},"Hawthorne","New York","10532",{"lat":120,"lon":121},41.10732,-73.79597,{"facility":80,"city":123,"state":124,"zip":125,"country":84,"geoPoint":126},"Cincinnati","Ohio","45229",{"lat":127,"lon":128},39.12711,-84.51439,{"facility":80,"city":130,"state":131,"zip":132,"country":84,"geoPoint":133},"Portland","Oregon","97239",{"lat":134,"lon":135},45.52345,-122.67621,{"facility":80,"city":137,"state":138,"zip":139,"country":84,"geoPoint":140},"Roanoke","Virginia","24016",{"lat":141,"lon":142},37.27097,-79.94143,{"facility":80,"city":144,"state":138,"zip":145,"country":84,"geoPoint":146},"Winchester","22601",{"lat":147,"lon":148},39.18566,-78.16333,[150],{"name":151,"role":152,"phone":153,"email":154},"Clinical Trial Disclosure & Transparency","CONTACT","215-832-3750","ClinicalTrialDisclosure@JazzPharma.com",[],[],[],{"nct_id":4,"conditions":159,"biomarkers":160},[19],[],{"nct_id":4,"found":15,"summary":162,"prompt_version":172},{"design":163,"status":164,"heading":165,"summary":166,"follow_up":167,"word_count":168,"commitments":169,"compensation":170,"drugs_mentioned":171},"This is a Phase 2\u002F3, multi-center study where participants will be randomly assigned to receive either JZP926 capsule or a placebo. Neither you nor your doctor will know which treatment you are receiving (double-blind).","completed","Study of JZP926 Capsule for Juvenile Myoclonic Epilepsy","This study is looking into a medication called JZP926 capsule for people with Juvenile Myoclonic Epilepsy (JME). JME is a type of epilepsy that causes sudden, brief muscle jerks, often in the morning. Researchers want to see how safe and effective JZP926 capsule is compared to a placebo (an inactive substance) in reducing the number of days you experience these myoclonic seizures. You might be able to join if you are at least 10 years old, have a diagnosis of JME, and have at least 4 myoclonic seizure days per 28 days. The study aims to measure how much JZP926 capsule changes your myoclonic seizure days over 16 weeks. The current status of this study is unclear, and it plans to enroll 260 participants.","The primary endpoint is measured up to the end of a 16-week treatment period.",124,"Not specified in the trial record.","Not stated in the trial record.",[23,40],"v2"]