[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xenon Pharmaceuticals Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":143},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,74,99,122],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100490516","phase-3-a-study-to-evaluate-xen1101-as-adjunctive-therapy-in-primary-generalized-tonic-clonic-seizures-100490516",false,"NCT05667142","A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures","A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures","X-ACKT","Key Inclusion Criteria:\n\n1. Subject is properly informed of the nature and risks of the study and gives informed consent in writing prior to entering the study (for adult subjects) and for adolescent subjects parent\u002Flegal guardian and subject gives informed consent or assent in writing prior to entering the study.\n2. Subject is ≥12 years of age with a BMI ≤40 kg\u002Fm2 at Visit 1.\n3. Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom.\n4. Subject has probable or possible PGTCS (with or without other subtypes of generalized seizures) for ≥1 year, in the setting of generalized epilepsy according to the International League Against Epilepsy 2017 classification criteria, and subject is approved by The Epilepsy Study Consortium (TESC).\n5. Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 3 months prior to the planned randomization (Visit 2), during screening\u002Fbaseline, and throughout the DBP.\n6. Subject is able to keep accurate seizure diaries.\n\nKey Exclusion Criteria:\n\n1. Subject has had status epilepticus within the 12 months prior to Visit 1.\n2. Subject has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.\n3. Subject has a history of non-epileptic psychogenic seizures within 10 years prior to Visit 1.\n4. Subject has a concomitant diagnosis of focal-onset seizures (FOS).\n5. Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.\n6. Subject has seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.\n7. Subject has history of neurosurgery for seizures \\\u003C1 year prior to Visit 1, or radiosurgery \\\u003C2 years prior to Visit 1.\n8. Subject has schizophrenia and other psychotic disorders (eg, schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified), bipolar disorder, or another serious mental health disorder. Subject has uncontrolled unipolar major depression where changes in pharmacotherapy are needed or anticipated during the study.\n9. Subject has any clinically significant laboratory abnormalities or clinically significant abnormalities on prestudy physical examination, vital signs, or ECG that, in the judgment of the investigator, indicate a medical problem that would preclude study participation, including but not limited to:\n\n   a. History or presence of long QT syndrome; QTcF \\>450 msec at baseline; family history of sudden death of unknown cause.\n10. Any personal circumstance that, in the opinion of the investigator, prevents adherence to the protocol.\n\nThe criteria to be eligible for randomization are:\n\n1. During the last 56 days that preceded the randomization visit (Visit 2), subject must have had a sufficient documented seizure frequency of PGTCS, including ≥1 PGTCS during each of the first and second 4-week periods preceding randomization. Retrospective seizure data documented up to 4 weeks prior to Visit 1 may be used in combination with a minimum of 4 weeks of prospective seizure data recorded in the study eDiary.\n2. Study eDiary was completed a minimum of 80% of all applicable days during the last 28-56 days of the baseline period that preceded randomization as evidence of adequate compliance (eg, \\>45 of 56 days, if no retrospective data prior to Visit 1 are used).\n3. Subject did not change dose of, stop, or initiate any new ASM(s) during the 3 months that preceded randomization and plans on maintaining a stable dose of ASM(s) during the DBP.","ALL","12 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS).",[27],"Primary Generalized Tonic-Clonic Seizures",[29],"Epilepsy","RECRUITING","2026-06-02",{"date":33,"type":34},"2026-06-03","ACTUAL",{"date":36,"type":34},"2023-02-14",{"date":38,"type":21},"2027-06",{"name":40,"class":41},"Xenon Pharmaceuticals Inc.","INDUSTRY",138,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100606204","phase-3-a-randomized-study-of-azetukalner-versus-placebo-in-depressive-episodes-associated-with-bipolar-i-or-ii-disorder-bipolar-depression-100606204","NCT07172516","A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)","A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)","X-CEED","Key Inclusion Criteria:\n\n* Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age.\n* Body Mass Index (BMI) ≥18 kg\u002Fm2 and ≤40 kg\u002Fm2.\n* Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder and is currently in a MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI).\n* Current MDE must has a duration of ≥4 weeks and ≤12 months.\n\nKey Exclusion Criteria:\n\n* Participant has any type of major depressive disorder (MDD) diagnosis, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression.\n* Participant has any nonbipolar psychiatric diagnosis.\n* Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit.\n* Participant has a symptomatic eating disorder within the 12 months prior to screening visit.\n* Participant has a Young Mania Rating Scale (YMRS) score \\>12 points at screening visit or randomization.\n* Participant has been hospitalized for mania within the 30 days prior to screening visit.\n* Participant is considered treatment-resistant in the current bipolar depressive episode, defined as having treatment resistance (no remission) to ≥2 different medications approved by the regional regulatory authority at an adequate dose (per regulatory approved label) and for an adequate duration (at least 6 weeks).\n* Participant has had an active suicidal plan\u002Fintent within the 6 months prior to screening, presence of suicidal behavior in the last 12 months.\n* Participant has self-injurious behavior without intent to die in the 12 months prior to screening.\n* Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 1 week or within a period less than 5 times the drug's half-life, whichever is longer prior to randomization.\n* Participants with medical conditions that may interfere with the purpose or conduct of the study.\n* Participant is pregnant, breastfeeding, or planning to become pregnant.","18 Years","74 Years",{"count":54,"type":21},400,[24],"X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).",[58,59,60,61],"Bipolar Disorder","Bipolar Depression","Bipolar I Disorder","Bipolar II Disorder",[63,64,65],"Bipolar","XEN1101","Azetukalner","2026-06-01",{"date":33,"type":34},{"date":69,"type":34},"2025-08-08",{"date":71,"type":21},"2028-08",{"name":40,"class":41},28,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100598816","phase-3-a-randomized-study-of-azetukalner-versus-placebo-in-major-depressive-disorder-x-nova3-100598816","NCT07076407","A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)","A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder","X-NOVA3","Key Inclusion Criteria:\n\n* Adults ≥18 and ≤74 years of age and experienced their first major depressive episode (MDE) prior to 50 years of age\n* Body Mass Index (BMI) ≤40 kg\u002Fm2\n* Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for current major depressive disorder and is currently in an MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI)\n* Participant's current MDE has a duration of ≥6 weeks and ≤24 months.\n\nKey Exclusion Criteria:\n\n* Participant has a primary diagnosis of a mood disorder other than MDD.\n* Participant has a history of any of the following: MDD with psychotic or catatonic features; MDD with mixed features; Bipolar I or II disorder; Obsessive-compulsive disorder; Schizophrenia, primary thought disorder, or other psychotic disorder.\n* Participant has a current diagnosis of any of the following: MDD with seasonal pattern; Depression with peripartum or perimenopausal onset; Post traumatic stress disorder; Antisocial or borderline personality disorder (or presence of clinically significant borderline personality traits); Panic disorder and\u002For agoraphobia; ADHD treated with a psychostimulant, diagnosed during the current MDE, or with unstable symptoms, as judged by the investigator.\n* Participant has a substance (excluding tobacco) or alcohol use disorder within the 12 months prior to screening.\n* Participant has had an active suicidal plan\u002Fintent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or \\>1 suicide attempt \\> 24 years of age.\n* Participant has a history of non-suicidal self-harm behavior in the 12 months prior to screening.\n* Participant has used antidepressants or other prohibited medications (including benzodiazepines), within the 2 weeks (4 weeks for fluoxetine) or within a period less than 5 times the drug's half-life, whichever is longer, prior to randomization.\n* Participant has a history of non-response to ≥2 antidepressant drugs of adequate dose and duration in the current MDE as determined by the Antidepressant Treatment Response Questionnaire (ATRQ).\n* Participants with medical conditions that may interfere with the purpose or conduct of the study\n* Participant is pregnant, breastfeeding, or planning to become pregnant.",{"count":83,"type":21},450,[24],"X-NOVA3 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)",[87],"Major Depressive Disorder",[89,90,64,65],"Depression","Antidepressant","2026-05-29",{"date":31,"type":34},{"date":94,"type":34},"2025-07-08",{"date":96,"type":21},"2027-07",{"name":40,"class":41},44,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100494278","phase-3-a-randomized-study-of-xen1101-versus-placebo-in-focal-onset-seizures-x-tole3-100494278","NCT05716100","A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)","A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures","Inclusion Criteria:\n\n* Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study\n* Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom.\n* Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP\n* Able to keep accurate seizure diaries\n\nExclusion Criteria:\n\n* Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.\n* History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.\n* Seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.\n* History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.\n* History of neurosurgery for seizures \\\u003C1 year prior to Visit 1, or radiosurgery \\\u003C2 years prior to enrollment.\n* Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.",{"count":107,"type":21},360,[24],"The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.",[111],"Focal Onset Seizures",[29],"2026-05-12",{"date":115,"type":34},"2026-05-14",{"date":117,"type":34},"2023-05-09",{"date":119,"type":21},"2026-12",{"name":40,"class":41},95,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":79,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},"100575676","phase-3-a-randomized-study-of-azetukalner-versus-placebo-in-major-depressive-disorder-100575676","NCT06775379","A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder","X-NOVA2","Key Inclusion Criteria:\n\n* Adults ≥18 and ≤74 years of age and experienced their first major depressive episode (MDE) prior to 50 years of age\n* Body Mass Index (BMI) ≤40 kg\u002Fm2\n* Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for current major depressive disorder and is currently in an MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI)\n* Participant's current MDE has a duration of ≥6 weeks and ≤24 months.\n\nKey Exclusion Criteria:\n\n* Participant has a primary diagnosis of a mood disorder other than MDD.\n* Participant has a history of any of the following: MDD with psychotic or catatonic features; MDD with mixed features; Bipolar I or II disorder; Obsessive-compulsive disorder; Schizophrenia, primary thought disorder, or other psychotic disorder.\n* Participant has a current diagnosis of any of the following: MDD with seasonal pattern; Depression with peripartum or perimenopausal onset; Post traumatic stress disorder; Antisocial or borderline personality disorder (or presence of clinically significant borderline personality traits); Panic disorder and\u002For agoraphobia; ADHD treated with a psychostimulant, diagnosed during the current MDE, or with unstable symptoms, as judged by the investigator.\n* Participant has a substance (excluding tobacco) or alcohol use disorder within the 12 months prior to screening.\n* Participant has had an active suicidal plan\u002Fintent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or \\>1 suicide attempt \\>24 years of age.\n* Participant has a history of non-suicidal self-harm behavior in the 12 months prior to screening.\n* Participant has used antidepressants or other prohibited medications (including benzodiazepines), within the 2 weeks (4 weeks for fluoxetine) or within a period less than 5 times the drug's half-life, whichever is longer, prior to randomization.\n* Participant has a history of non-response to ≥2 antidepressant drugs of adequate dose and duration in the current MDE as determined by the Antidepressant Treatment Response Questionnaire (ATRQ).\n* Participants with medical conditions that may interfere with the purpose or conduct of the study\n* Participant is pregnant, breastfeeding, or planning to become pregnant.",{"count":83,"type":21},[24],"X-NOVA2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)",[87],[89,90,64,65],"2025-10-20",{"date":136,"type":34},"2025-10-22",{"date":138,"type":34},"2024-12-20",{"date":140,"type":21},"2026-10",{"name":40,"class":41},46,""]