[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648514":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":33,"centralContacts":34,"locations":33,"responsibleParty":40,"collaborators":42,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":33,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":33,"enrollmentInfo":54,"targetDuration":33,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":65,"whyStopped":33,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":33},{"fullName":5,"class":6},"Jazz Pharmaceuticals","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"CBD-OS","EXPERIMENTAL","Participants with DEE will be randomized to CBD-OS up to 10 mg\u002Fkg twice daily for a 6-week treatment period.",[13],"Drug: CBD-OS",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants with DEE will be randomized to matching placebo for a 6-week treatment period.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Open-Label Extension: CBD-OS","Participants with DEE who completed the double-blind phase of the study and enter the optional OLE will begin a 22-week open-label treatment period with CBD-OS up to 10 mg\u002Fkg twice daily following a 2-week Blinded Transition Period.",[13],[25,31],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Oral solution, twice daily",[9,21],[30],"JZP926-OS",{"type":26,"name":15,"description":27,"armGroupLabels":32,"otherNames":33},[15],null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Clinical Trial Disclosure & Transparency","CONTACT","215-832-3750","ClinicalTrialDisclosure@JazzPharma.com",{"type":41,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[43],{"name":44,"class":6},"Jazz Pharmaceuticals Research UK Limited","100648514","phase-3-a-study-to-evaluate-the-safety-and-efficacy-of-cbd-os-in-participants-with-dee-100648514",false,"NCT07723976","A Study to Evaluate the Safety and Efficacy of CBD-OS in Participants With DEE","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Cannabidiol Oral Solution (CBD-OS, JZP926-OS) in Participants Aged 1 Year and Older With Developmental and Epileptic Encephalopathy (DEE)","Participants are eligible to be included in the study only if all the following criteria apply:\n\n1. Is at least 1 year of age at the time of signing the informed consent\u002Fassent.\n2. Meets the clinical phenotype for DEE as specified in the protocol.\n3. Per the investigator, the underlying etiology contributes to developmental impairment and seizures.\n4. Has had, or is willing to complete, confirmatory imaging and\u002For genetic testing to determine etiology of DEE.\n5. Is currently receiving antiseizure intervention, such as treatment with a stable regimen of at least 1 ASM or an established intervention for epilepsy (eg, ketogenic diet or neurostimulation).\n6. All medications or interventions for epilepsy have been stable for ≥ 28 days prior to starting the baseline period (Visit 2) with no planned changes to the regimen for the duration of the Double-blind Treatment Period.\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. 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.\n2. The etiology of the participant's seizures is a progressive neurologic disease.\n3. Has known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention, such as sesame oil.\n4. Has an active central nervous system (CNS) infection, demyelinating disease, degenerative neurologic disease, or any CNS disease deemed to be progressive during the study that may confound the interpretation of the study results (including autoimmune encephalitis).\n5. Is currently being treated with Epidiolex or recently received treatment with Epidiolex within 28 days prior to screening.\n6. Has experienced a lack of efficacy and\u002For poor tolerability to an adequate treatment regimen of Epidiolex based on medical history and the clinical judgement of the investigator. Participants who discontinued treatment for reasons other than safety, tolerability, or lack of efficacy and previously received Epidiolex ≥ 28 days prior to starting the Baseline Period (Visit 2) may be eligible for the study after consultation with the medical monitor and\u002For sponsor representative.\n7. Has been taking felbamate for less than 12 months prior to screening. Participants who are stable on felbamate for ≥ 12 months are eligible for inclusion.","ALL","1 Year",{"count":55,"type":56},120,"ESTIMATED","INTERVENTIONAL",[59],"PHASE3","The efficacy, safety, and tolerability of CBD-OS have been evaluated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and Tuberous sclerosis complex (TSC). The current JZP926-303 study is being conducted to evaluate the safety and efficacy of CBD-OS in participants with Developmental and Epileptic Encephalopathy (DEE).",[62],"Developmental and Epileptic Encephalopathy (DEE)",[64,30,9],"Developmental and Epileptic Encephalopathy","NOT_YET_RECRUITING","2026-07-22",{"date":68,"type":69},"2026-07-24","ACTUAL",{"date":71,"type":56},"2026-10-30",{"date":73,"type":56},"2029-09-04",{"name":5,"class":6}]