[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05718817":3,"trial-entities:NCT05718817":1117,"trial-summary:NCT05718817":1122},{"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":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":40,"secondary_outcomes":45,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":70,"locations":74,"central_contacts":1110,"overall_officials":1111,"references":1115,"see_also_links":1116},"NCT05718817","XPF-010-304","An Open-label Study of XEN1101 in Epilepsy","A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy","ENROLLING_BY_INVITATION","2033-06","2026-07","2026-07-08","2023-04-25","Xenon Pharmaceuticals Inc.","INDUSTRY",true,"This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 6 years.","This is an Open Label Extension study of the following Phase 3 clinical studies: XPF-010-301 (X-TOLE2), XPF-010-302 (X-TOLE3), and XPF-010-303 (X-ACKT). This study will evaluate the long-term safety, tolerability, PK, and efficacy of XEN1101 in subjects with FOS or PGTCS for the treatment of seizures for up to 6 years. Subjects who successfully completed and did not terminate early from one of the antecedent studies (X-TOLE2, X-TOLE3, or X-ACKT) are eligible to participate in X-TOLE4.\n\nFollowing enrollment into X-TOLE4, subjects will undergo a treatment period of up to 6 years, during which there will be a visit at 2-, 4-, and 13-weeks post-entry, with subsequent visits occurring at 13-week intervals during the first year, and then at 26-week intervals (with a telephone call in between) until dosing is completed.\n\nSubjects will be initially assigned to XEN1101 as follows:\n\n* 25 mg QD for subjects aged ≥18 years\n* For subjects aged ≥12 and \\\u003C18 years\n\n  * 15 mg QD for those\n\n    * who weigh \\\u003C45 kg at the start of the X-TOLE4 study\n    * who weighed \\\u003C45 kg during the X-ACKT study\n    * who weighed ≥45 kg at randomization in the X-ACKT study and had dose reduction(s) for intolerability\n  * 25 mg QD for all others\n\nSubjects will be instructed to orally take XEN1101 once daily (QD) with an evening meal. Subjects will be expected to keep a daily seizure eDiary with a minimum of 80% compliance for the duration of the extension study (reporting on ≥80% of days between visits).\n\nUpon completion of dosing at the end of the treatment period, there will be an 8-week follow up period.",[19,20],"Focal Epilepsy","Tonic-Clonic Seizures",[22,23],"Epilepsy","Seizures","INTERVENTIONAL","TREATMENT",[27],"PHASE3",{"count":29,"type":30},880,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","XEN1101","XEN1101 capsules",[37],"XEN1101 15 or 25 mg\u002Fday",[39],"Azetukalner",[41],{"measure":42,"description":43,"timeFrame":44},"The adverse events","To assess the safety and tolerability of XEN1101","From the start of treatment in the open-label extension (OLE) study through 8 weeks after the last dose.",[46,50,53,56,59],{"measure":47,"description":48,"timeFrame":49},"Change in monthly seizure rate","Percent change in monthly seizure rate recorded at baseline (in the antecedent studies) compared to each 4-week assessment period in the treatment period in X-TOLE4.","From baseline through the active extension treatment (Week 312).",{"measure":51,"description":52,"timeFrame":49},"Proportion of responders","Proportion of responders (subjects experiencing ≥50% reduction in seizure frequency from baseline) in each consecutive 4-week assessment period of the treatment period of the OLE study.",{"measure":54,"description":55,"timeFrame":49},"Change in Clinical Global Impression of Severity (CGI-S)","Improvement in Clinical Global Impression of Severity (CGI-S) scores over time.",{"measure":57,"description":58,"timeFrame":49},"Change in Patient Global Impression of Severity (PGI-S)","Improvement in Patient Global Impression of Severity (PGI-S) scores over time.",{"measure":60,"description":61,"timeFrame":49},"Change in Quality of Life in Epilepsy Inventory (QOLIE-31)","Change in the 31-Item Quality of Life in Epilepsy Inventory (QOLIE-31) over time.","ALL","12 Years",null,false,{"inclusion":67,"exclusion":68,"raw_text":69},[],[],"Inclusion Criteria:\n\n1. Subject must be properly informed of the nature and risks of the study and give informed consent in writing prior to entering the study (for adult subjects) and for adolescent subject's parent\u002Flegal guardian and subject gives informed consent or assent in writing prior to entering the study.\n2. Subject must have successfully completed the double-blind treatment period (DBP) and have not terminated early from Study X-TOLE2, X-TOLE3, or X-ACKT, met all eligibility requirements, and had no important protocol deviations (in the opinion of the sponsor) or adverse events (AEs) (in the opinion of the investigator) that would preclude the subject's entry into the long-term extension study.\n3. In the opinion of the investigator, the subject is able to understand verbal and written instructions and will adhere to all study schedules and requirements.\n4. Subject is able to keep accurate seizure diaries.\n\nExclusion Criteria:\n\n1. Subject met any of the withdrawal criteria while in Study X-TOLE2, X-TOLE3, or X-ACKT.\n2. Subject has any medical condition, personal circumstance, or ongoing AE (from Study X-TOLE2, X-TOLE3, or X-ACKT) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol.\n3. Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy or any other medical condition during the study and until 28 days after completion of this study.",[71,72,73],"CHILD","ADULT","OLDER_ADULT",[75,84,91,99,107,114,121,129,137,144,151,158,165,172,180,188,196,204,212,216,224,232,239,247,254,262,269,276,283,291,299,307,315,321,325,332,339,347,354,361,369,376,383,391,399,403,411,419,426,433,441,449,456,464,472,480,484,488,492,496,500,504,508,515,522,529,536,545,552,559,566,573,580,587,594,601,609,616,624,631,639,646,655,663,670,678,685,693,696,699,707,711,719,727,734,738,745,752,760,764,772,779,786,793,800,807,814,822,830,838,845,852,860,867,874,881,890,897,901,907,915,921,929,936,943,950,957,961,969,976,983,990,994,998,1005,1013,1020,1027,1031,1034,1038,1041,1048,1055,1062,1071,1079,1086,1092,1096,1103],{"facility":76,"city":77,"state":78,"zip":79,"country":80,"geoPoint":81},"Xenoscience","Phoenix","Arizona","85004","United States",{"lat":82,"lon":83},33.44838,-112.07404,{"facility":85,"city":86,"state":78,"zip":87,"country":80,"geoPoint":88},"University of Arizona - Health Sciences","Tucson","85724",{"lat":89,"lon":90},32.22174,-110.92648,{"facility":92,"city":93,"state":94,"zip":95,"country":80,"geoPoint":96},"Clinical Trials, Inc","Little Rock","Arkansas","72205",{"lat":97,"lon":98},34.74648,-92.28959,{"facility":100,"city":101,"state":102,"zip":103,"country":80,"geoPoint":104},"Brain Science Research Institute","Los Angeles","California","90025",{"lat":105,"lon":106},34.05223,-118.24368,{"facility":108,"city":109,"state":102,"zip":110,"country":80,"geoPoint":111},"UC Irvine Health","Orange","92868",{"lat":112,"lon":113},33.78779,-117.85311,{"facility":115,"city":116,"state":102,"zip":117,"country":80,"geoPoint":118},"University of California, Davis Clinical & Translational Science Center Clinical Research (CCRC)","Sacramento","95817",{"lat":119,"lon":120},38.58157,-121.4944,{"facility":122,"city":123,"state":124,"zip":125,"country":80,"geoPoint":126},"University of Colorado Hospital Anschutz Outpatient Pavilion","Aurora","Colorado","80045",{"lat":127,"lon":128},39.72943,-104.83192,{"facility":130,"city":131,"state":132,"zip":133,"country":80,"geoPoint":134},"Mayo Clinic Florida","Jacksonville","Florida","32224",{"lat":135,"lon":136},30.33218,-81.65565,{"facility":138,"city":139,"state":132,"zip":140,"country":80,"geoPoint":141},"Serenity Research Center, LLC","Miami","33176",{"lat":142,"lon":143},25.77427,-80.19366,{"facility":145,"city":146,"state":132,"zip":147,"country":80,"geoPoint":148},"Research Institute of Orlando, LLC","Orlando","32806",{"lat":149,"lon":150},28.53834,-81.37924,{"facility":152,"city":153,"state":132,"zip":154,"country":80,"geoPoint":155},"Panhandle Research & Medical Clinic","Pensacola","10021",{"lat":156,"lon":157},30.42131,-87.21691,{"facility":159,"city":160,"state":132,"zip":161,"country":80,"geoPoint":162},"University of South Florida","Tampa","33606",{"lat":163,"lon":164},27.94752,-82.45843,{"facility":166,"city":167,"state":132,"zip":168,"country":80,"geoPoint":169},"Encore Medical Research of Weston, LLC","Weston","33331",{"lat":170,"lon":171},26.10037,-80.39977,{"facility":173,"city":174,"state":175,"zip":176,"country":80,"geoPoint":177},"Hawaii Pacific Neuroscience","Honolulu","Hawaii","96817",{"lat":178,"lon":179},21.30694,-157.85833,{"facility":181,"city":182,"state":183,"zip":184,"country":80,"geoPoint":185},"Consultants in Epilepsy and Neurology","Boise","Idaho","83704",{"lat":186,"lon":187},43.6135,-116.20345,{"facility":189,"city":190,"state":191,"zip":192,"country":80,"geoPoint":193},"Indiana University School of Medicine","Indianapolis","Indiana","46202",{"lat":194,"lon":195},39.76838,-86.15804,{"facility":197,"city":198,"state":199,"zip":200,"country":80,"geoPoint":201},"The University of Kansas Medical Center","Kansas City","Kansas","66103",{"lat":202,"lon":203},39.11417,-94.62746,{"facility":205,"city":206,"state":207,"zip":208,"country":80,"geoPoint":209},"Bluegrass Epilepsy Research, LLC","Lexington","Kentucky","40504",{"lat":210,"lon":211},37.98869,-84.47772,{"facility":213,"city":206,"state":207,"zip":214,"country":80,"geoPoint":215},"Kentucky Clinic","40536",{"lat":210,"lon":211},{"facility":217,"city":218,"state":219,"zip":220,"country":80,"geoPoint":221},"MMP Neurology","Scarborough","Maine","04074",{"lat":222,"lon":223},43.57814,-70.32172,{"facility":225,"city":226,"state":227,"zip":228,"country":80,"geoPoint":229},"University of Maryland Medical Center","Baltimore","Maryland","21201",{"lat":230,"lon":231},39.29038,-76.61219,{"facility":233,"city":234,"state":227,"zip":235,"country":80,"geoPoint":236},"Mid-Atlantic Epilepsy and Sleep Center","Bethesda","20817",{"lat":237,"lon":238},38.98067,-77.10026,{"facility":240,"city":241,"state":242,"zip":243,"country":80,"geoPoint":244},"Brigham and Women's Hospital","Boston","Massachusetts","02115",{"lat":245,"lon":246},42.35843,-71.05977,{"facility":248,"city":249,"state":242,"zip":250,"country":80,"geoPoint":251},"UMass Chan Medical School","Worcester","06155",{"lat":252,"lon":253},42.26259,-71.80229,{"facility":255,"city":256,"state":257,"zip":258,"country":80,"geoPoint":259},"University of Michigan Hospitals","Ann Arbor","Michigan","48109-2435",{"lat":260,"lon":261},42.27756,-83.74088,{"facility":263,"city":264,"state":257,"zip":265,"country":80,"geoPoint":266},"Wayne State University","Detroit","48201",{"lat":267,"lon":268},42.33143,-83.04575,{"facility":270,"city":271,"state":257,"zip":272,"country":80,"geoPoint":273},"Michigan State University","East Lansing","48824",{"lat":274,"lon":275},42.73698,-84.48387,{"facility":277,"city":278,"state":257,"zip":279,"country":80,"geoPoint":280},"Cornwell Health (Spectrum Health Hospitals)","Grand Rapids","49503",{"lat":281,"lon":282},42.96336,-85.66809,{"facility":284,"city":285,"state":286,"zip":287,"country":80,"geoPoint":288},"Minneapolis Clinic of Neurology","Burnsville","Minnesota","55337",{"lat":289,"lon":290},44.76774,-93.27772,{"facility":292,"city":293,"state":294,"zip":295,"country":80,"geoPoint":296},"Saint Louis University Medical School","St Louis","Missouri","63104",{"lat":297,"lon":298},38.62727,-90.19789,{"facility":300,"city":301,"state":302,"zip":303,"country":80,"geoPoint":304},"Northeast Epilepsy Group","Hackensack","New Jersey","07601",{"lat":305,"lon":306},40.88593,-74.04347,{"facility":308,"city":309,"state":310,"zip":311,"country":80,"geoPoint":312},"Dent Neurosciences Research Center","Buffalo","New York","14226",{"lat":313,"lon":314},42.88645,-78.87837,{"facility":316,"city":310,"state":310,"zip":317,"country":80,"geoPoint":318},"New York University Comprehensive Epilepsy Center","10016",{"lat":319,"lon":320},40.71427,-74.00597,{"facility":322,"city":310,"state":310,"zip":323,"country":80,"geoPoint":324},"Mount Sinai Health","10029",{"lat":319,"lon":320},{"facility":326,"city":327,"state":310,"zip":328,"country":80,"geoPoint":329},"SUNY Upstate Medical University","Syracuse","13210",{"lat":330,"lon":331},43.04812,-76.14742,{"facility":333,"city":334,"state":310,"zip":335,"country":80,"geoPoint":336},"Montefiiore Medical Center","The Bronx","10467",{"lat":337,"lon":338},40.84985,-73.86641,{"facility":340,"city":341,"state":342,"zip":343,"country":80,"geoPoint":344},"Onsite Clinical Solutions","Charlotte","North Carolina","28211",{"lat":345,"lon":346},35.22709,-80.84313,{"facility":348,"city":349,"state":342,"zip":350,"country":80,"geoPoint":351},"Duke University","Durham","27710",{"lat":352,"lon":353},35.99403,-78.89862,{"facility":355,"city":356,"state":342,"zip":357,"country":80,"geoPoint":358},"Meridian Clinical Research, LLC","Raleigh","27607",{"lat":359,"lon":360},35.7721,-78.63861,{"facility":362,"city":363,"state":364,"zip":365,"country":80,"geoPoint":366},"Summa Health","Akron","Ohio","44304",{"lat":367,"lon":368},41.08144,-81.51901,{"facility":370,"city":371,"state":364,"zip":372,"country":80,"geoPoint":373},"Cleveland Clinic Foundation","Cleveland","44195",{"lat":374,"lon":375},41.4995,-81.69541,{"facility":377,"city":378,"state":364,"zip":379,"country":80,"geoPoint":380},"The Ohio State University Brain and Spine Hospital","Columbus","43210",{"lat":381,"lon":382},39.96118,-82.99879,{"facility":384,"city":385,"state":386,"zip":387,"country":80,"geoPoint":388},"Providence Neurological Specialities","Portland","Oregon","97225",{"lat":389,"lon":390},45.52345,-122.67621,{"facility":392,"city":393,"state":394,"zip":395,"country":80,"geoPoint":396},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"lat":397,"lon":398},39.95238,-75.16362,{"facility":400,"city":393,"state":394,"zip":401,"country":80,"geoPoint":402},"Thomas Jefferson University","19107",{"lat":397,"lon":398},{"facility":404,"city":405,"state":406,"zip":407,"country":80,"geoPoint":408},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"lat":409,"lon":410},36.16589,-86.78444,{"facility":412,"city":413,"state":414,"zip":415,"country":80,"geoPoint":416},"Austin Epilepsy Care Center","Austin","Texas","78758",{"lat":417,"lon":418},30.26715,-97.74306,{"facility":420,"city":421,"state":414,"zip":422,"country":80,"geoPoint":423},"ANESC Research","El Paso","79912",{"lat":424,"lon":425},31.75872,-106.48693,{"facility":427,"city":428,"state":414,"zip":429,"country":80,"geoPoint":430},"UT Health San Antonio","San Antonio","78229",{"lat":431,"lon":432},29.42412,-98.49363,{"facility":434,"city":435,"state":436,"zip":437,"country":80,"geoPoint":438},"University of Utah Clinical Neurosciences Center","Salt Lake City","Utah","84132",{"lat":439,"lon":440},40.76078,-111.89105,{"facility":442,"city":443,"state":444,"zip":445,"country":80,"geoPoint":446},"Carilion Clinic","Roanoke","Virginia","24013",{"lat":447,"lon":448},37.27097,-79.94143,{"facility":450,"city":451,"state":444,"zip":452,"country":80,"geoPoint":453},"Sentara Neurology Specialists","Virginia Beach","23456",{"lat":454,"lon":455},36.85293,-75.97799,{"facility":457,"city":458,"state":459,"zip":460,"country":80,"geoPoint":461},"University of Washington Main Hospital","Seattle","Washington","10012",{"lat":462,"lon":463},47.60621,-122.33207,{"facility":465,"city":466,"state":467,"zip":468,"country":80,"geoPoint":469},"Aurora St. Luke's Medical Center","Milwaukee","Wisconsin","53215",{"lat":470,"lon":471},43.0389,-87.90647,{"facility":473,"city":474,"zip":475,"country":476,"geoPoint":477},"Hospital General de Agudos \"José M. Ramos Mejía\"","Buenos Aires","1221","Argentina",{"lat":478,"lon":479},-34.61315,-58.37723,{"facility":481,"city":474,"zip":482,"country":476,"geoPoint":483},"Asociacion Medica de Lomas de Zamora S.A. - Policlinicio Lomas","B1832BQD",{"lat":478,"lon":479},{"facility":485,"city":474,"zip":486,"country":476,"geoPoint":487},"STAT Research S.A.","C1023AAB",{"lat":478,"lon":479},{"facility":489,"city":474,"zip":490,"country":476,"geoPoint":491},"Centro de Psicología Médica San Martín de Tours SRL (CITES-INECO)","C1060AAF",{"lat":478,"lon":479},{"facility":493,"city":474,"zip":494,"country":476,"geoPoint":495},"Hospital Italiano de Buenos Aires","C1199ABB",{"lat":478,"lon":479},{"facility":497,"city":474,"zip":498,"country":476,"geoPoint":499},"Hospital Britanico de Buenos Aires","C1280AEB",{"lat":478,"lon":479},{"facility":501,"city":474,"zip":502,"country":476,"geoPoint":503},"CENyR, Centro de Especialidades Neurologicas u Rehabilitacion","C1424BYD",{"lat":478,"lon":479},{"facility":505,"city":474,"zip":506,"country":476,"geoPoint":507},"FLENI (Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia)","C1428DGG",{"lat":478,"lon":479},{"facility":509,"city":510,"zip":511,"country":476,"geoPoint":512},"Hospital Córdoba","Córdoba","X5000",{"lat":513,"lon":514},-31.40648,-64.18853,{"facility":516,"city":517,"zip":518,"country":476,"geoPoint":519},"Hospital De Alta Complejidad en Red El Cruce - Dr Nester Carlos Kirchner Servicio de Atencion Medica Integral Para la Communidad","San Juan Bautista","1888",{"lat":520,"lon":521},-34.80896,-58.27623,{"facility":523,"city":524,"zip":525,"country":476,"geoPoint":526},"Hospital Central Ramon Carrillo","San Luis","5701",{"lat":527,"lon":528},-33.2914,-66.32467,{"facility":530,"city":531,"zip":532,"country":476,"geoPoint":533},"Sanatorio del SUR S.A.","San Miguel de Tucumán","4000",{"lat":534,"lon":535},-26.81601,-65.21051,{"facility":537,"city":538,"state":539,"zip":540,"country":541,"geoPoint":542},"Prince of Wales Hospital","Randwick","New South Wales","2031","Australia",{"lat":543,"lon":544},-33.91439,151.24895,{"facility":546,"city":547,"zip":548,"country":541,"geoPoint":549},"Royal Prince Alfred Hospital","Camperdown","2050",{"lat":550,"lon":551},-33.88965,151.17642,{"facility":553,"city":554,"zip":555,"country":541,"geoPoint":556},"St Vincent's Hospital Melbourne","Fitzroy","3065",{"lat":557,"lon":558},-37.79839,144.97833,{"facility":560,"city":561,"zip":562,"country":541,"geoPoint":563},"Austin Health Pharmacy Clinical Trials","Heidelberg","3084",{"lat":564,"lon":565},-37.75,145.06667,{"facility":567,"city":568,"zip":569,"country":541,"geoPoint":570},"Southern Neurology","Kogarah","2217",{"lat":571,"lon":572},-33.9681,151.13564,{"facility":574,"city":575,"zip":576,"country":541,"geoPoint":577},"Alfred Hospital Neurology CT Dept of Neuroscience","Melbourne","30004",{"lat":578,"lon":579},-37.814,144.96332,{"facility":581,"city":582,"zip":583,"country":541,"geoPoint":584},"The Royal Melbourne Hospital","Parkville","3050",{"lat":585,"lon":586},-37.78333,144.95,{"facility":588,"city":589,"zip":590,"country":541,"geoPoint":591},"Mater Misericordiae Ltd South Brisbane","South Brisbane","4101",{"lat":592,"lon":593},-27.48034,153.02049,{"facility":595,"city":596,"zip":597,"country":541,"geoPoint":598},"Westmead Hospital Dept. of Neurology Epilepsy Unit","Westmead","2145",{"lat":599,"lon":600},-33.80383,150.98768,{"facility":602,"city":603,"zip":604,"country":605,"geoPoint":606},"University Hospital Innsbruck","Innsbruck","6020","Austria",{"lat":607,"lon":608},47.26266,11.39454,{"facility":610,"city":611,"zip":612,"country":605,"geoPoint":613},"Universitatsklinik fur Neurologie, Medizinische Universitat Wien","Vienna","1090",{"lat":614,"lon":615},48.20849,16.37208,{"facility":617,"city":618,"zip":619,"country":620,"geoPoint":621},"Cliniques Universitaires Saint-Luc (UCL)","Brussels","1200","Belgium",{"lat":622,"lon":623},50.85045,4.34878,{"facility":625,"city":626,"zip":627,"country":620,"geoPoint":628},"Universitair Ziekenhuis Gent","Ghent","9000",{"lat":629,"lon":630},51.05,3.71667,{"facility":632,"city":633,"zip":634,"country":635,"geoPoint":636},"Hospital for active treatmnt Puls AD Neurology Dpt","Blagoevgrad","2700","Bulgaria",{"lat":637,"lon":638},42.01457,23.09804,{"facility":640,"city":641,"zip":642,"country":635,"geoPoint":643},"MHATNP St. Naum","Sofia","1113",{"lat":644,"lon":645},42.69751,23.32415,{"facility":647,"city":648,"state":649,"zip":650,"country":651,"geoPoint":652},"Center for Neurologic Research","Lethbridge","Alberta","T1J 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