Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT05267405
Status:
UNKNOWN
Last Update Posted:
2022-03-04
First Post:
2022-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mainz Epilepsy Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D000091323', 'term': 'Psychogenic Nonepileptic Seizures'}, {'id': 'D013226', 'term': 'Status Epilepticus'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-23', 'studyFirstSubmitDate': '2022-02-11', 'studyFirstSubmitQcDate': '2022-02-23', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'monthly seizure frequency after 6 months', 'timeFrame': '6 months', 'description': 'monthly seizure frequency at the follow-up after 6 months'}, {'measure': 'European Quality of Life 5 dimensions Index (EQ 5D Index)', 'timeFrame': '6 months', 'description': 'health-related quality of life measured by EQ5D-Index (European Quality of Life 5 dimensions), rating from 0 (worst possible state) to 1 (best possible state)'}, {'measure': 'monthly seizure frequency after 12 months', 'timeFrame': '12 months', 'description': 'monthly seizure frequency at the follow-up after 12 months'}, {'measure': 'European Quality of Life 5 dimensions Index (EQ 5D Index)', 'timeFrame': '12 months', 'description': 'health-related quality of life measured by EQ5D-Index (European Quality of Life 5 dimensions), rating from 0 (worst possible state) to 1 (best possible state)'}, {'measure': 'Seizure freedom', 'timeFrame': '6 months', 'description': 'percentage of patients without epileptic seizures'}, {'measure': 'Seizure freedom', 'timeFrame': '12 months', 'description': 'percentage of patients without epileptic seizures'}, {'measure': 'interruption of status epilepticus', 'timeFrame': '48 hours', 'description': 'percentage of patients with interrupted status epilepticus'}], 'secondaryOutcomes': [{'measure': 'Resilience Scale 13', 'timeFrame': '12 months', 'description': 'Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low resilience, 67-72 with moderate and 73-91 with high resilience'}, {'measure': 'Resilience Scale 13', 'timeFrame': '24 months', 'description': 'Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low resilience, 67-72 with moderate and 73-91 with high resilience'}, {'measure': 'Multidimensional Fatigue Inventory', 'timeFrame': '12 months', 'description': 'Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores'}, {'measure': 'Multidimensional Fatigue Inventory', 'timeFrame': '24 months', 'description': 'Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores'}, {'measure': 'Beck Depression Inventory II', 'timeFrame': '12 months', 'description': 'Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)'}, {'measure': 'Beck Depression Inventory II', 'timeFrame': '24 months', 'description': 'Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)'}, {'measure': 'Berlin Social Support Scales (BSSS)', 'timeFrame': '12 months', 'description': 'Berlin Social Support Scales (BSSS) is used to assess the amount of emotional, informational and instrumental support received by patients: Total scores ranged from 15 to 60, higher scores identify better support'}, {'measure': 'Berlin Social Support Scales (BSSS)', 'timeFrame': '24 months', 'description': 'Berlin Social Support Scales (BSSS) is used to assess the amount of emotional, informational and instrumental support received by patients: Total scores ranged from 15 to 60, higher scores identify better support'}, {'measure': 'World Health Organization Quality of Life-BREF (WHOQOL-BREF)', 'timeFrame': '12 months', 'description': 'World Health Organization Quality of Life-BREF (WHOQOL-BREF), a scale to assess overall quality of life with a range 0-100 (higher scores correspond better quality of life)'}, {'measure': 'World Health Organization Quality of Life-BREF (WHOQOL-BREF)', 'timeFrame': '24 months', 'description': 'World Health Organization Quality of Life-BREF (WHOQOL-BREF), a scale to assess overall quality of life with a range 0-100 (higher scores correspond better quality of life)'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '12 months', 'description': 'Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances, scoring between 0 and 21 with higher scores corresponding to worse sleep quality'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '24 months', 'description': 'Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances, scoring between 0 and 21 with higher scores corresponding to worse sleep quality'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy', 'Dissociative Seizures', 'Status Epilepticus']}, 'referencesModule': {'references': [{'pmid': '39096467', 'type': 'DERIVED', 'citation': 'Winter Y, Abou Dargham R, Patino Tobon S, Groppa S, Fuest S. Cenobamate as an Early Adjunctive Treatment in Drug-Resistant Focal-Onset Seizures: An Observational Cohort Study. CNS Drugs. 2024 Sep;38(9):733-742. doi: 10.1007/s40263-024-01109-9. Epub 2024 Aug 3.'}, {'pmid': '37784006', 'type': 'DERIVED', 'citation': 'Winter Y, Sandner K, Vieth T, Gonzalez-Escamilla G, Stuckrad-Barre SV, Groppa S. Third-Generation Antiseizure Medication in the Treatment of Benzodiazepine-Refractory Status Epilepticus in Poststroke Epilepsy: A Retrospective Observational Register-Based Study. CNS Drugs. 2023 Oct;37(10):929-936. doi: 10.1007/s40263-023-01039-y. Epub 2023 Oct 2.'}]}, 'descriptionModule': {'briefSummary': 'Prospective longitudinal observational registry study of all patients with epilepsy treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.', 'detailedDescription': 'Clinical parameters of patients, such as onset of the disease, prior medication, disease severity, which are important for the data analysis also collected retrospectively before the initiation of the registry. Data on the quality of life is collected only prospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated in Mainz Comprehensive Epilepsy and Sleep Medicine Center', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Epileptic or psychogenic seizures\n\nExclusion Criteria:\n\n* age\\<18\n* patients who cannot provide informed consent and don't have a legal guardian"}, 'identificationModule': {'nctId': 'NCT05267405', 'acronym': 'MAINZ-EPIREG', 'briefTitle': 'Mainz Epilepsy Registry', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Study on Disease Course and Quality of Life in Patients With Epilepsy (Mainz Epilepsy Registry)', 'orgStudyIdInfo': {'id': 'MAINZ-EPIREG'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no interventions, only observation', 'type': 'OTHER', 'description': 'no interventions, only observation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Winter Yaroslav, MD, MSc', 'role': 'CONTACT', 'email': 'yaroslav.winter@unimedizin-mainz.de', 'phone': '+496131172234'}], 'facility': 'Mainz Comprehensive Epilepsy and Sleep Medicine Center', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'centralContacts': [{'name': 'Yaroslav Winter, MD, MSc', 'role': 'CONTACT', 'email': 'yaroslav.winter@unimedizin-mainz.de', 'phone': '+496131172234'}], 'overallOfficials': [{'name': 'Yaroslav Winter, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mainz Comprehensive Epilepsy and Sleep Medicine Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Mainz Comprehensive Epilepsy and Sleep Medicine Center', 'investigatorFullName': 'Dr. Yaroslav Winter', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}