Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-02-09 @ 1:27 AM
Study NCT ID:
NCT02788318
Status:
TERMINATED
Last Update Posted:
2019-04-03
First Post:
2016-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080485', 'term': 'Sudden Unexpected Death in Epilepsy'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Brain tissue (brainstem, hippocampus and insula) and fibroblasts culture'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'difficulty recruiting patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2016-05-27', 'studyFirstSubmitQcDate': '2016-05-27', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Density of Medullary 5-HT Neurons', 'timeFrame': 'between 1 to 30 hours following death', 'description': '5-HT1A receptor binding density in within the medulla'}], 'secondaryOutcomes': [{'measure': 'Other markers of 5HT within the medulla', 'timeFrame': 'between 1 to 30 hours following death', 'description': 'Expression of 5HT-1A and 5HT-2 receptors, expression of 5HT transporter, Tryptophan Hydroxylase 2 (TPH2)'}, {'measure': 'Serotoninergic pathway in the pons, the hippocampus and the insula', 'timeFrame': 'between 1 to 30 hours following death', 'description': '5-HT1A receptor binding density, Expression of 5HT-1A and 5HT-2 receptors, expression of 5HT transporter, Tryptophan Hydroxylase 2 (TPH2)'}, {'measure': 'Catecholaminergic pathway', 'timeFrame': 'between 1 to 30 hours following death', 'description': 'Number of neurons expressing the tyrosine hydroxylase, expression of alpha and beta adrenergic receptors, expression of dopamine-bêta-hydroxylase'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'SUDEP', 'Serotonin'], 'conditions': ['Sudden Unexpected Death in Epilepsy (SUDEP)']}, 'descriptionModule': {'briefSummary': 'The mortality rate is increased in patients with epilepsy, and especially among patients with drug-resistant epilepsy. This increased mortality is mainly related to the risk of SUDEP whose incidence is between 3.5 and 9 per 1,000 for patients with drug-resistant epilepsy. The term SUDEP refers to a sudden death occurring in a patient with epilepsy in whom anamnestic and post-mortem evidence does not identify a particular cause. Experimental and clinical data strongly suggest that most of SUDEP result from a postictal respiratory dysfunction progressing to terminal apnea. Due to the major role of serotonin in regulating breathing rhythms and data in animal models of epilepsy, it is envisaged that an alteration of serotonergic systems of the brainstem and limbic regions may play a central role in the occurrence of SUDEP. The objective of this work is to look for abnormalities of the serotonergic transmission within regulatory regions of respiratory and autonomic functions in brain samples prospectively collected in patients died from SUDEP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with epilepsy who died', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Postmortem time before autopsy \\<30 hours\n\nExclusion Criteria:\n\n* Age \\<18 years\n* postmortem time before autopsy \\> 30 hours\n* Any subject whose brain would be of forensic interest\n* Any patient who expressed an opposition to organ donation.'}, 'identificationModule': {'nctId': 'NCT02788318', 'acronym': 'SUDEP', 'briefTitle': 'Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP)', 'orgStudyIdInfo': {'id': 'D50830'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'diagnostic of SUDEP', 'description': 'patient with epilepsy in whom anamnestic and post-mortem evidence does not identify a particular cause (diagnosis of SUDEP). Brain samples and skin samples are collected.', 'interventionNames': ['Other: Brain samples', 'Other: Skin samples']}, {'label': 'Control 1', 'description': 'Subjects with a known epilepsy, whose death is linked to a specific cause. Brain samples and skin samples are collected.', 'interventionNames': ['Other: Brain samples', 'Other: Skin samples']}, {'label': 'Control 2', 'description': 'Subjects without known pathological history, remained victims of unexplained sudden unexpected death (SUDEP) after all investigations and for which a heart rhythm disorder is suspected in first intention. Brain samples and skin samples are collected.', 'interventionNames': ['Other: Brain samples', 'Other: Skin samples']}], 'interventions': [{'name': 'Brain samples', 'type': 'OTHER', 'description': 'Collected in patients died', 'armGroupLabels': ['Control 1', 'Control 2', 'diagnostic of SUDEP']}, {'name': 'Skin samples', 'type': 'OTHER', 'description': 'Collected in patients died', 'armGroupLabels': ['Control 1', 'Control 2', 'diagnostic of SUDEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon - Institut Médico-Légal', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}