[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07728097":3,"trial-entities:NCT07728097":152,"trial-summary:NCT07728097":155},{"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":15,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":41,"secondary_outcomes":45,"sex":123,"minimum_age":124,"maximum_age":15,"healthy_volunteers":125,"eligibility_criteria":126,"std_ages":130,"locations":133,"central_contacts":143,"overall_officials":149,"references":150,"see_also_links":151},"NCT07728097","JZP926-403","A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS","A Phase 3b\u002F4, Interventional, Prospective, Multicenter, Open-Label Study Evaluating the Effectiveness of a Gradual Titration Regimen to Optimize CBD-OS as Add-On Therapy in Adults With Lennox-Gastaut Syndrome","NOT_YET_RECRUITING","2028-12-28","2026-07","2026-07-27","2026-11-18","Jazz Pharmaceuticals","INDUSTRY",null,"This is a Phase 3b\u002FPhase 4 study. The purpose of this study is to learn more about the efficacy of using CBD-OS as an add-on therapy for the treatment of LGS in adults.",[18],"Lennox-Gastaut Syndrome",[20,21,22,23,24],"LGS","Cannabidiol","CBD-OS","Epidiolex","Epidyolex","INTERVENTIONAL","TREATMENT",[28],"PHASE4",{"count":30,"type":31},40,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","Cannabidiol Oral Solution","100 mg\u002Fml Cannabidiol Oral solution (CBD-OS)",[38],"Cannabidiol Oral Solution Treatment group",[40,22,23,24],"JZP926",[42],{"measure":43,"timeFrame":44},"Percentage of participants reporting 50% or more reduction in their 28-day average countable major motor seizure frequency","End of Treatment Period, Week 24",[46,50,54,57,60,62,66,69,72,75,78,82,85,88,92,95,98,101,104,107,109,111,115,118,120],{"measure":47,"description":48,"timeFrame":49},"Retention Rate","Retention Rate is defined as percentage of participants completing or continuing CBD-OS treatment at different timepoints in the study","At Weeks 8, 12, 16 and 24",{"measure":51,"description":52,"timeFrame":53},"Percentage of participants experiencing worsening, change, no change or improvement in in their 28-day average countable major motor and total seizure frequency","As reported in participants' electronic diaries","Baseline to Week 4, Baseline to Week 8, Baseline to Week 12, Baseline to Week 16, Baseline to Week 24",{"measure":55,"description":56,"timeFrame":53},"Percentage of participants considered treatment responders","Treatment responders will be categorized as those experiencing a 50% or more reduction, a 75% or more reduction or 100% reduction in their 28-day average seizure frequency as reported in participants' electronic diaries",{"measure":58,"description":59,"timeFrame":53},"Change in 28-day average frequency of countable major motor and total seizures","Assessed per 28 days from electronic diary entries",{"measure":61,"description":59,"timeFrame":53},"Change in number of seizure-free days",{"measure":63,"description":64,"timeFrame":65},"Change in CaGI-S severity of seizure scores","Caregiver Global Impression of Severity (CaGI-S) is a single-item, 5-point Likert-type rating scale (ranging from 0 \"not severe at all\" to 5 \"very severe\"). Using this scale, caregivers will be asked to rate their impression of the participant's severity of seizures, and the severity of the impact caused by the seizure.","Baseline to Week 16, Baseline to Week 24",{"measure":67,"description":68,"timeFrame":65},"Change in CaGI-S severity of impact of seizures scores","Caregiver Global Impression of Severity (CaGI-S) is a single-item, 5-point Likert-type rating scale (ranging from 0 \"not severe at all\" to 5 \"very severe\"). Using this scale, caregivers will be asked to rate their impression of the participant's severity of the impact caused by the seizure.",{"measure":70,"description":71,"timeFrame":65},"Change in VAS scores","Visual Analog Scale (VAS) is a caregiver-reported tool used to quantify the severity of impact of subjective non-seizure symptoms and assesses sleep, communication, and disruptive behavior. The VAS enables sensitive detection of changes in non-seizure domains (disruptive behavior, Sleep, and Communication) important to patients with LGS and their caregivers. The VAS has a total score ranging from 0 to 100 with the higher score indicating worse conditions.",{"measure":73,"description":74,"timeFrame":65},"Change in CaGI-S severity of level of alertness scores","CaGI-S Alertness is a caregiver single item assessment on a 5-point Likert-type rating scale (ranging from 0 \"not severe at all\" to 5 \"very severe\") assessing their impression of participant's severity of level of awareness",{"measure":76,"description":77,"timeFrame":65},"Change in CaGI-S severity of overall condition scores","CaGI-S Overall Condition is a caregiver single item assessment on a 5-point Likert-type rating scale (ranging from 0 \"not severe at all\" to 5 \"very severe\") assessing their impression of participant's severity of overall condition",{"measure":79,"description":80,"timeFrame":81},"CaGI-C level of alertness scores","Caregiver Global Impression of Change (CaGI-C) Alertness is a caregiver single item assessment on a 7-point Likert-type rating scale (ranging from 1 \"very much improved\" to 7 \"very severe\") assessing their impression of participant's severity of level of awareness","At Week 16, at week 24",{"measure":83,"description":84,"timeFrame":81},"CaGI-C overall condition scores","Caregiver Global Impression of Change (CaGI-C) overall condition is a caregiver single item assessment on a 7-point Likert-type rating scale (ranging from 1 \"very much improved\" to 7 \"very severe\") assessing their impression of participant's severity of overall condition",{"measure":86,"description":87,"timeFrame":65},"Change in CGI-S overall condition scores","Clinician Global Impression of severity (CGI-S) Overall Condition is a clinician single item assessment on a 5-point Likert-type rating scale (ranging from 1 \"not severe at all\" to 5 \"very severe\") assessing their impression of participant's severity of level of overall condition",{"measure":89,"description":90,"timeFrame":91},"CGI-C overall condition scores","Clinician Global Impression of Change (CGI-C) Overall Condition is a clinician single item assessment on a 7-point Likert-type rating scale (ranging from 1 \"very much improved\" to 5 \"very much worse\") assessing their impression of participant's change of overall condition","At Week 16, At Week 24",{"measure":93,"description":94,"timeFrame":65},"Change in ELDQOL Behavior subscale scores","Epilepsy and Learning Disabilities Quality of Life (ELDQOL) is designed for the caregiver to rate the quality of life (QOL) in children with severe epilepsy and learning disabilities over the last month. The questionnaire has a total of 28 main questions, grouped into 4 subscales: behavior, seizure severity, mood, and side effects. The ELDQOL behavior subscale includes 9 of the 28 total main questions with a total score ranging from 9 to 36 with the higher score indicating greater behavioral problems",{"measure":96,"description":97,"timeFrame":65},"Change in ELDQOL seizure severity subscale scores","Epilepsy and Learning Disabilities Quality of Life (ELDQOL) is designed for the caregiver to rate the quality of life (QOL) in children with severe epilepsy and learning disabilities over the last month. The questionnaire has a total of 28 main questions, grouped into 4 subscales: behavior, seizure severity, mood, and side effects. The ELDQOL seizure severity subscale includes 14 of the 28 total main questions with a total score ranging from 10 to 56 with the higher score indicating greater seizure severity",{"measure":99,"description":100,"timeFrame":65},"Change in ELDQOL mood scale subscale scores","Epilepsy and Learning Disabilities Quality of Life (ELDQOL) is designed for the caregiver to rate the quality of life (QOL) in children with severe epilepsy and learning disabilities over the last month. The questionnaire has a total of 28 main questions, grouped into 4 subscales: behavior, seizure severity, mood, and side effects. The ELDQOL mood scale subscale includes 1 of the 28 total questions with a total score ranging from 16 to 64 with the higher score indicating greater mood problems",{"measure":102,"description":103,"timeFrame":65},"Change in ELDQOL side-effects profile subscale scores","Epilepsy and Learning Disabilities Quality of Life (ELDQOL) is designed for the caregiver to rate the quality of life (QOL) in children with severe epilepsy and learning disabilities over the last month. The questionnaire has a total of 28 main questions, grouped into 4 subscales: behavior, seizure severity, mood, and side effects. The ELDQOL side-effects profile subscale includes 2 of the 28 total main questions with a score ranging from 19 to 76 with the higher score indicating greater side effects",{"measure":105,"timeFrame":106},"Number of participants reporting adverse events leading to discontinuation","Up to week 24",{"measure":108,"timeFrame":106},"Time the adverse events started from baseline",{"measure":110,"timeFrame":106},"Number of Participants with Abnormal Laboratory Values",{"measure":112,"description":113,"timeFrame":114},"Change in suicidal ideation scores","As evaluated by the Columbia-Suicide Severity Rating Scale (C-SSRS). The questionnaire has a total score ranging from 0 to 5 with a score of 0 indicating no suicidal ideation is present.","Baseline, up to week 24",{"measure":116,"description":117,"timeFrame":114},"Change in number of suicide attempts","As per the response in the C-SSRS",{"measure":119,"timeFrame":106},"Percentage of participants requiring inpatient hospitalization due to epilepsy",{"measure":121,"timeFrame":122},"Change in number of usage of rescue medication","Baseline, Up to week 24","ALL","18 Years",false,{"inclusion":127,"exclusion":128,"raw_text":129},[],[],"Inclusion Criteria:\n\n1. Has a confirmed clinical diagnosis of LGS with a history of seizures and actively experiencing seizures within 6 months of screening.\n2. Is naïve to CBD-OS treatment or has been off CBD-OS treatment for at least 3 months prior to screening.\n3. Is willing to maintain any factors expected to affect seizures (eg, alcohol consumption, smoking, concomitant medication usage) stable for the duration of the study.\n4. Is currently treated with at least 1 ASM, but no more than 3 ASMs, and is on a stable regimen for at least 4 weeks prior to screening.\n5. Adequate contraceptive precautions\n6. Participant has a primary caregiver\u002Flegally authorized representative (LAR) who is willing and able, in the investigator's opinion, to participate throughout the duration of the study and to comply with all study requirements\n7. Experienced at least 4 or more countable major motor seizures (isolated seizures or seizures occurring in a cluster) during the 5-week Baseline Period preceding treatment.\n8. Caregiver completed at least 80% of seizure diary entries during the Baseline Period with no more than 3 consecutive days of missing entries.\n\nExclusion Criteria:\n\n1. Has a significant psychiatric illness\n2. Has an illness during the 4 weeks prior to screening other than epilepsy which, in the investigator's opinion, could affect study outcomes or seizure frequency.\n3. Has history of SE in the 3 months prior to screening.\n4. Has any other significant disease other than epilepsy, which, in the investigator's opinion, may either put the participant, other participants, or site staff at risk because of participation in the study, may influence the result of the study, or may affect the participant's ability to take part in the study.\n5. Has previously undergone significant surgery for epilepsy in the 6 months prior to screening or planned to undergo surgery for epilepsy during the study.\n6. Is currently using or has in the past used recreational or medicinal cannabis or synthetic cannabinoid-based medications, products, or supplements within the 3 months prior to screening and is not willing to undergo a 1-month washout period before being rescreened.\n7. Has initiated felbamate within the 12 months prior to screening.\n8. Is not willing to adjust dosage of CBD-OS if needed when using strong inducers of CYP3A4 and\u002For strong inducers of CYP2C19 concomitantly with CBD-OS\n9. Previously discontinued cannabidiol due to severe adverse events (SAE), hypersensitivity or lack of efficacy\n10. Has clinically significant abnormal lab values\n11. Has clinically impaired hepatic or renal function\n12. History of, current risk or presence of actual suicidal ideations\n13. Has any known or suspected hypersensitivity to cannabinoids or any of the excipients of CBD-OS, such as sesame oil.\n14. Has a known or suspected history of alcohol or substance abuse disorder\n15. Is currently consuming, and unwilling to stop consumption, or planning to consume tonic water on a regular basis throughout the study.",[131,132],"ADULT","OLDER_ADULT",[134],{"facility":135,"city":136,"state":137,"zip":138,"country":139,"geoPoint":140},"Louisiana State University Health Sciences Center New Orleans","New Orleans","Louisiana","70112","United States",{"lat":141,"lon":142},29.95465,-90.07507,[144],{"name":145,"role":146,"phone":147,"email":148},"Clinical Trial Disclosure & Transparency","CONTACT","215-832-3750","ClinicalTrialDisclosure@JazzPharma.com",[],[],[],{"nct_id":4,"conditions":153,"biomarkers":154},[18],[],{"nct_id":4,"found":156,"summary":157,"prompt_version":167},true,{"design":158,"status":159,"heading":160,"summary":161,"follow_up":162,"word_count":163,"commitments":164,"compensation":165,"drugs_mentioned":166},"This is a Phase 3b\u002FPhase 4 interventional study, meaning it's testing a treatment that has already shown some promise. It plans to enroll about 40 participants.","completed","Study of Cannabidiol Oral Solution for Lennox-Gastaut Syndrome","This study is looking into how well Cannabidiol Oral Solution (CBD-OS) works as an add-on treatment for adults with Lennox-Gastaut Syndrome (LGS), a severe form of epilepsy. Researchers want to see if gradually increasing the dose of CBD-OS can help reduce seizures. You might be able to join if you are an adult (18 years or older) with a confirmed LGS diagnosis, have had seizures recently, and haven't used CBD-OS in the last three months. The study will consider it a success if a significant number of participants see their major motor seizures reduced by 50% or more over 28 days by the end of the 24-week treatment period. The current status of this study is unclear, but it plans to enroll about 40 participants.","The primary endpoint is measured at the end of the 24-week treatment period, but further follow-up is not specified.",125,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]