Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-02-03 @ 12:45 AM
Study NCT ID:
NCT01884766
Status:
COMPLETED
Last Update Posted:
2017-09-19
First Post:
2013-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Copeptin in Childhood Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D003294', 'term': 'Seizures, Febrile'}], '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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-18', 'studyFirstSubmitDate': '2013-05-10', 'studyFirstSubmitQcDate': '2013-06-20', 'lastUpdatePostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'number of repeated events of seizures', 'timeFrame': '12 month', 'description': 'relapse of seizures within 12 month'}], 'primaryOutcomes': [{'measure': 'Copeptin concentration in serum', 'timeFrame': 'at admission'}], 'secondaryOutcomes': [{'measure': 'base excess in blood gas analysis', 'timeFrame': 'at admission'}, {'measure': 'prolactin', 'timeFrame': 'at admission'}, {'measure': 'duration of seizures', 'timeFrame': 'at admission'}, {'measure': 'Short term relapse of seizures', 'timeFrame': '24 hours after first presentation'}, {'measure': 'sodium concentration', 'timeFrame': 'at admission'}, {'measure': 'osmolality', 'timeFrame': 'at admission'}, {'measure': 'hydrogen ion activity in blood gas analysis', 'timeFrame': 'at admission', 'description': 'hydrogen ion activity = pH'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Epilepsy', 'Febrile Seizures', 'Children']}, 'referencesModule': {'references': [{'pmid': '25894585', 'type': 'DERIVED', 'citation': 'Stocklin B, Fouzas S, Schillinger P, Cayir S, Skendaj R, Ramser M, Weber P, Wellmann S. Copeptin as a serum biomarker of febrile seizures. PLoS One. 2015 Apr 20;10(4):e0124663. doi: 10.1371/journal.pone.0124663. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'In many fields of medicine, except seizure disorders, blood biomarkers have captured an integrated part of diagnostic decision making, including copeptin, the surrogate marker of vasopressin release. There are strong arguments to hypothesize circulating copeptin is elevated in epilepsy, especially in generalized seizures such as fever seizures (FS), and that copeptin is predictive for complexity and relapse at least in FS. Although long-term morbidity and mortality are both low in FS, there is high anxiety among parents because of a lack of criterions to identify children at risk for relapse. Copeptin may fill this gap by adding important diagnostic and prognostic information. Eventually, less children may receive needlessly over years fever drugs or anti-epileptic drugs.', 'detailedDescription': 'Background:\n\nCopeptin is a surrogate marker of the pituitary-secreted nonapeptide arginine-vasopressin (AVP) and has gradually replaced AVP in several clinical studies largely due to its structural and methodological advantages. Copeptin is a marker of non-specific stress response, and has been suggested to have clinical implications in a variety of cardiovascular and non-cardiovascular conditions. However, up to now there are no data available on copeptin in seizure disorders, neither in adults nor in children.\n\nWorking hypotheses:\n\n1. Circulating copeptin concentrations are increased after generalized seizures, including FS.\n2. Copeptin is predictive for complexity and relapse in FS.\n\nSpecific aims:\n\n1. to determine copeptin concentrations in children below six years after generalized seizures, either unrelated or related to fever (FS), and in control children below six years without seizures.\n2. to compare copeptin concentrations with blood-gas parameters (including hydrogen ion concentration (pH), base deficiency, and carbon dioxide), lactate, sodium, chloride, C reactive protein (CRP), and prolactin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Children below six years presenting at the emergency unit of one tertiary university children's hospital", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria epilepsy-cohort:\n\n* All kind of seizures leading to presentation\n* Age below 6 years\n\nInclusion Criteria control-cohort:\n\n* Fever without seizures caused by banal infections\n* Age below 6 years\n\nExclusion Criteria:\n\n* No blood required for medical reasons'}, 'identificationModule': {'nctId': 'NCT01884766', 'acronym': 'EpiCop', 'briefTitle': 'Copeptin in Childhood Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Prospective Study on Copeptin in Childhood Epilepsy', 'orgStudyIdInfo': {'id': 'EKBB 352/12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epilepsy', 'description': 'All kind of epilepsy, including febrile seizures'}, {'label': 'Control', 'description': 'children without seizures at presentation in the emergency but fever due to banal infections'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4056', 'city': 'Basel', 'country': 'Switzerland', 'facility': "University Children's Hospital Basel", 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Sven Wellmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University Children's Hospital Basel, 4056 Basel, Switzerland"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': "University Children's Hospital Basel", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}