Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-28 @ 7:57 PM
Study NCT ID:
NCT05376150
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000710655', 'term': 'XEN1101'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'dispFirstSubmitDate': '2024-09-13', 'completionDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-13', 'studyFirstSubmitDate': '2022-05-11', 'studyFirstSubmitQcDate': '2022-05-11', 'dispFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score.', 'timeFrame': 'From baseline to end of treatment (Week 6).'}, {'measure': 'Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.', 'timeFrame': 'From randomization to Week 10.'}], 'secondaryOutcomes': [{'measure': 'Change in Snaith-Hamilton Pleasure Scale (SHAPS) score.', 'timeFrame': 'From baseline to end of treatment (Week 6).'}, {'measure': 'Change in Beck Anxiety Inventory (BAI) score.', 'timeFrame': 'From baseline to end of treatment (Week 6).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'Potassium channel', 'Depression'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '40423966', 'type': 'DERIVED', 'citation': 'Butterfield NN, Luzon Rosenblut C, Fava M, Correll CU, Rothschild AJ, Murrough JW, Mathew SJ, Beatch GN, Grayson C, Harden C, Qian J, McIntosh J, Namdari R, Kenney C. Azetukalner, a Novel KV7 Potassium Channel Opener, in Adults With Major Depressive Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2514278. doi: 10.1001/jamanetworkopen.2025.14278.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, Phase 2, double-blind, randomized, parallel-arm, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of XEN1101 in subjects with Major Depressive Disorder.', 'detailedDescription': 'The study is divided into 3 stages: Screening - up to 4 weeks duration; Treatment - 6 weeks duration; Follow-up - 4 weeks duration. The total study duration per subject is estimated to be approximately 14 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Be properly informed of the nature and risks of the study and given written informed consent.\n* Male or female, aged 18 through 65 years (inclusive) with a body mass index (BMI) ≤35 kg/m².\n* Subject must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current MDD and currently in a moderate to severe major depressive episode (MDE), confirmed using the Mini International Neuropsychiatric Interview (MINI).\n* Current MDE duration ≥2 months and \\<24 months at the time of screening.\n* Current illness severity that is at least moderate, defined as a score of ≥20 on the HAM-D17 at screening and on Day 1.\n* Score ≥20 on the SHAPS at screening and on Day1.\n* Must be willing to comply with the study protocol for the full term of the study.\n\nKey Exclusion Criteria:\n\n* A primary psychiatric diagnosis other than MDD as defined by DSM-5 (comorbid anxiety disorders \\[including agoraphobia, generalized anxiety disorder, social anxiety disorder, post-traumatic stress disorder (PTSD), and panic disorder\\] are allowed).\n* Concomitant use of antidepressants and/or other disallowed pharmacotherapy (including benzodiazepines).\n* History of schizophrenia or other psychotic disorder, MDD with psychotic features, bipolar I or II disorder, or MDD with mixed features.\n* History of non-response to \\>1 antidepressant drug due to lack of efficacy in the current MDE.\n* Failing \\>3 antidepressant drug trials, for any reason, in the current MDE.\n* History of non-response to electroconvulsive therapy (ECT) in the past 10 years.\n* Active suicidal plan/intent in the past 6 months, or more than 1 lifetime suicide attempt.\n* Females who are pregnant, breastfeeding, or planning to become pregnant during the first administration of study drug until 3 months after the last dose of study drug.\n* Meets criteria for a substance use disorder within the past 12 months, with the exception of tobacco use, and/or has a positive urine toxicology screen for drugs of abuse.\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.'}, 'identificationModule': {'nctId': 'NCT05376150', 'acronym': 'X-NOVA', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xenon Pharmaceuticals Inc.'}, 'officialTitle': 'A Proof-of-Concept, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 in Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'XPF-008-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XEN1101 10 mg', 'description': 'During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 10 mg, orally with food, per day', 'interventionNames': ['Drug: XEN1101 10 mg']}, {'type': 'EXPERIMENTAL', 'label': 'XEN1101 20 mg', 'description': 'During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 20 mg, orally with food, per day', 'interventionNames': ['Drug: XEN1101 20 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'During the double blind treatment period (42 days), subjects will take 1 capsule of placebo, orally with food, per day', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'XEN1101 10 mg', 'type': 'DRUG', 'description': 'XEN1101 oral capsule', 'armGroupLabels': ['XEN1101 10 mg']}, {'name': 'XEN1101 20 mg', 'type': 'DRUG', 'description': 'XEN1101 oral capsule', 'armGroupLabels': ['XEN1101 20 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsule', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Research Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '94549', 'city': 'Lafayette', 'state': 'California', 'country': 'United States', 'facility': 'Sunwise Clinical Research, LLC', 'geoPoint': {'lat': 37.88576, 'lon': -122.11802}}, {'zip': '90660', 'city': 'Pico Rivera', 'state': 'California', 'country': 'United States', 'facility': 'California Neuropsychopharmacology Clinical Research Institute', 'geoPoint': {'lat': 33.98307, 'lon': -118.09673}}, {'zip': '92503', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridian International Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Global Medical Institutes (GMI)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'CCM Clinical Reseach Group, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'i-Research, Atlanta', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Psych Atlanta, PC', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'iResearch', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60123', 'city': 'Elgin', 'state': 'Illinois', 'country': 'United States', 'facility': 'Revive Research Institute, Inc.', 'geoPoint': {'lat': 42.03725, 'lon': -88.28119}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Altea Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08009', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hassman Research Institute', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Bio Behavioral Health', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '11516', 'city': 'Cedarhurst', 'state': 'New York', 'country': 'United States', 'facility': 'Neurobehavioral Research, Inc. (NBR)', 'geoPoint': {'lat': 40.62288, 'lon': -73.7243}}, {'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Behavioral Medicine, PLLC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Richard M Weisler and Association', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'FutureSearch Trials of Dallas, LP', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'AIM Trials', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xenon Pharmaceuticals Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xenon Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}