Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-03 @ 8:05 PM
Study NCT ID:
NCT04287361
Status:
COMPLETED
Last Update Posted:
2020-03-12
First Post:
2020-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clonazepam in Children Status Epilepticus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013226', 'term': 'Status Epilepticus'}], 'ancestors': [{'id': 'D012640', 'term': 'Seizures'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2020-02-26', 'lastUpdatePostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effectiveness in stopping seizures', 'timeFrame': '1 day', 'description': 'The primary endpoint was clinical cessation of seizures, which was defined as the absence of clinical signs of seizures immediately following the injection of clonazepam.'}], 'secondaryOutcomes': [{'measure': 'need for a second dose of clonazepam', 'timeFrame': '1 day', 'description': 'need for a second dose of clonazepam'}, {'measure': 'duration of seizure', 'timeFrame': '1 day', 'description': 'duration of seizure (minutes)'}, {'measure': 'type of seizures', 'timeFrame': '1 day', 'description': 'type of seizures (focal, generalized);'}, {'measure': 'aetiologies ;', 'timeFrame': '1 day', 'description': 'aetiologies (idiopathic, symptomatic)'}, {'measure': 'pre-hospital treatment used', 'timeFrame': '1 day', 'description': 'pre-hospital treatment used'}, {'measure': 'whether or not to use a dose greater than one milligram', 'timeFrame': '1 day', 'description': 'whether or not to use a dose greater than one milligram'}, {'measure': 'introduction of a maintenance dose', 'timeFrame': '1 day', 'description': 'introduction of a maintenance dose'}, {'measure': 'using another antiepileptic drug', 'timeFrame': '1 day', 'description': 'using another antiepileptic drug (phenobarbital, fosphenytoin, thiopental)'}, {'measure': 'Hospitalization in an intensive care or resuscitation unit', 'timeFrame': '1 day', 'description': 'Hospitalization in an intensive care or resuscitation unit'}, {'measure': 'Rate of hospitalization in conventional sector', 'timeFrame': '1 day', 'description': 'Rate of hospitalization in conventional sector'}, {'measure': 'introduction of antiepileptic treatment after treatment', 'timeFrame': '1 day', 'description': 'introduction of antiepileptic treatment after treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepticus Status']}, 'descriptionModule': {'briefSummary': '•Background: Intravenous clonazepam is the most widely used first-line benzodiazepine in Europe for the initial management of status epilepticus in children.\n\nThe guidelines of the "Société de reanimation de langue francaise" (SRLF) and the "société française de médecine d\'urgence" (SFMU) published in 2018 recommend an initial loading dose of 0.015 mg / kg of clonazepam in this situation (maximum 1.5 mg).\n\nTo our knowledge, there is no specific study of the efficacy of clonazepam according to the dose used.\n\nObjective: To compare the effectiveness of the initial loading dose of clonazepam in children treated for status epilepticus\n\n•Methods: Monocentric retrospective study including children \\< 16 years who have benefited from an initial loading dose of clonazepam in the context of status epilepticus treated at the Montpellier University Hospital between January 2016 and June 2019.\n\nThe investigators collected data from medical records (clinic, treatment , evolution) and compared these according to the dosage of clonazepam used.\n\n•Discussion: Among the benzodiazepines used in the first-line treatment of pediatric status epileptic, lorazepam and midazolam are the most widely used drugs in the world.\n\nLorazepam is not so much used in Europe because the injectable form is not available for a daily use. Conversely, clonazepam is used in a large number of European countries but is rarely used in the United States due to the lack of an injectable form.\n\nAbout the tolerance of treatment, except overdose situations, clonazepam is a drug well tolerated in the pediatric populatin. The main side effects of clonazepam are respiratory depression and impaired alertness.\n\nTo our knowledge, this study is the first to examine the efficacy depending on the initial loading dosage of clonazepam in children status epilepticus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'An individual must fulfill all of the following criteria in order to be eligible for study enrollment:\n\n* Aged under 16 years\n* Status epilepticus taken care of at the CHU de Montpellier', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nAn individual must fulfill all of the following criteria in order to be eligible for study enrollment:\n\n* Aged under 16 years\n* Status epilepticus taken care of at the CHU de Montpellier\n\nExclusion criteria\n\n● No loading dose of clonazepam'}, 'identificationModule': {'nctId': 'NCT04287361', 'acronym': 'UHAPA', 'briefTitle': 'Clonazepam in Children Status Epilepticus', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Efficacy of Intravenous Clonazepam According to the Dosage in Children Status Epilepticus', 'orgStudyIdInfo': {'id': 'RECHMPL19_0501'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Loading dose < 0,03 mg/kg', 'description': 'Patient being treated for a status epilepticus who received an initial dose of clonazepam \\< 0.03 mg / kg', 'interventionNames': ['Other: Efficacy of intravenous clonazepam']}, {'label': 'Loading dose ≥ 0,03 mg/kg', 'description': 'Patient being treated for a status epilepticus who received an initial dose of clonazepam ≥ 0.03 mg / kg', 'interventionNames': ['Other: Efficacy of intravenous clonazepam']}], 'interventions': [{'name': 'Efficacy of intravenous clonazepam', 'type': 'OTHER', 'description': 'Efficacy of intravenous clonazepam', 'armGroupLabels': ['Loading dose < 0,03 mg/kg', 'Loading dose ≥ 0,03 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uh Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Maxime colmard, résident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals of Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}