Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2026-02-21 @ 2:02 AM
Study NCT ID:
NCT02883712
Status:
TERMINATED
Last Update Posted:
2021-03-12
First Post:
2016-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Predictors of Response to Anti Epilepsy in Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasmatic and serum samples for the dosage of the drugs Leucocytes for the intracellular dosage of the drugs DNA for pharmacogenetics analysis of the metabolism and pharmacodynamic targets of the drugs DNA for the genetic causes of epilepsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'defect inclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-09', 'studyFirstSubmitDate': '2016-08-16', 'studyFirstSubmitQcDate': '2016-08-24', 'lastUpdatePostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical global impression of the patient', 'timeFrame': '3 months', 'description': 'Clinical global impression assessment'}], 'secondaryOutcomes': [{'measure': 'Number of seizure', 'timeFrame': '3 months', 'description': 'recorded on the agenda of patients'}, {'measure': 'Quality of life', 'timeFrame': '3 months', 'description': 'Analyse with the Quality Of Life In Epilepsy Questionnaire'}, {'measure': 'Adverse events', 'timeFrame': '3 months', 'description': 'reported by the patients with a particular attention to attention and concentration worsening on interview'}, {'measure': 'Concentration of the anti epileptic drug', 'timeFrame': '3 months', 'description': 'plasmatic drug concentration will be systematically'}, {'measure': "Pharmacogenetics of the uridine 5'-diphosphate glucuronosyltransférases (UGT1A1, UGT2B7, UGT1A4)", 'timeFrame': '3 months', 'description': 'the metabolism pathways of the drug'}, {'measure': 'Pharmacogenetics of the Cytochrome P450 (2D6, 2C9, 2C19)', 'timeFrame': '3 months', 'description': 'the metabolism pathways of the drug'}, {'measure': 'Depression inventory for epilepsy', 'timeFrame': '3 months', 'description': 'Neurological Disorders Depression Inventory for Epilepsy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['epilepsy', 'pharmacoresistant', 'antiepileptic drug', 'pharmacokinetic', 'pharmacodynamic', 'pharmacogenetic'], 'conditions': ['Seizure']}, 'descriptionModule': {'briefSummary': "Pharmacoresistant epilepsy remains around 30% despite the development of 25 anti epileptic drugs. Of course, this can be explained by pharmacoresistant epileptic brain diseases, as exemplified by some genetic diseases. However, the lack of specific guidelines for the choice of the anti epileptic drugs (apart from generalized and partial epilepsy) and the very large number of drugs with different and sometimes complex metabolism are challenges for neurologists. Among the 30 % of pharmacoresistant epilepsy, there is a part related to pharmacokinetic drawbacks that could be overcome with a more rigorous approach (i.e. dosage and pharmacogenetics tools). Moreover, the new anti epileptic drugs have metabolism more unrelated with the cytochrome P450 and less generalised adverse events. However, their metabolism could be more complexe (i.e. the less known Uridine 5'-diphospho-glucuronyltransferase (UGT) pathway) and bring more insidious neurological adverse events (i.e. depression, anxiety exacerbation, cognitive disorders worsening) which could largely impede the observance and the quality of life even if the number of seizure is reduced or not. The goal is to determine the predictive and the modulating factors of pharmacoresistance with a global analysis (i.e. whatever the anti epileptic drugs) and with a specific analysis (drug by drug) from a cohort of 1000 patients.", 'detailedDescription': 'The goal is to determine the predictive and the modulating factors of pharmacoresistance with a global analysis (i.e. whatever the anti epileptic drugs) and with a specific analysis (drug by drug with their specific metabolism pathways) from a cohort of 1000 patients. The response to the antiepileptic drugs modification will be analyse 3 months after the modification, with the analysis of the number of seizures, the quality of life, the Clinical Global Impression, the adverse events, the systematic dosage of all the molecules (residual concentration just before the taken) and the pharmacogenetic analysis of the main metabolism pathways and the main pharmacodynamic targets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients referred to our center with epilepsy (pharmacoresistant or pharmacosensitive)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Epileptic patients who required a treatment adaptation\n\nExclusion Criteria:\n\n* patients unable to give reliable information and without caregiver\n* pregnancy\n* Severe comorbidity, which would impede interpretation'}, 'identificationModule': {'nctId': 'NCT02883712', 'acronym': 'RESISTANT', 'briefTitle': 'Study of Predictors of Response to Anti Epilepsy in Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Study of Predictors of Response to Anti Epilepsy in Epilepsy', 'orgStudyIdInfo': {'id': '2011_37'}, 'secondaryIdInfos': [{'id': '2012-A00916-37', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'David DEVOS, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}