Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-29 @ 5:35 AM
Study NCT ID:
NCT01268904
Status:
UNKNOWN
Last Update Posted:
2010-12-31
First Post:
2010-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Intravenous Valproate in Pediatric Status Epilepticus and Acute Repetitive Seizures
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014635', 'term': 'Valproic Acid'}], 'ancestors': [{'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-30', 'studyFirstSubmitDate': '2010-12-30', 'studyFirstSubmitQcDate': '2010-12-30', 'lastUpdatePostDateStruct': {'date': '2010-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of intravenous valproate in pediatric status epilepticus', 'timeFrame': 'One week'}], 'secondaryOutcomes': [{'measure': 'Efficacy of intravenous valproate in pediatric status epilepticus', 'timeFrame': 'One week'}]}, 'conditionsModule': {'conditions': ['Status Epilepticus']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of intravenous valproate in pediatric status epilepticus and acute repetitive seizures as part of seizure treatment protocol in pediatric ER'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric inpatients and emergency patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child with clinical presentation of status epilepticus\n\nExclusion Criteria:\n\n* All others'}, 'identificationModule': {'nctId': 'NCT01268904', 'briefTitle': 'Safety and Efficacy of Intravenous Valproate in Pediatric Status Epilepticus and Acute Repetitive Seizures', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': '0098-10-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric status epilepticus', 'interventionNames': ['Drug: Valproate']}], 'interventions': [{'name': 'Valproate', 'type': 'DRUG', 'description': 'Intravenous valproate application to pediatric patients suffering from status epilepticus and acute repetitive seizures', 'armGroupLabels': ['Pediatric status epilepticus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Iyad Magadly, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Iyad Magadly, MD', 'role': 'CONTACT', 'email': 'magadly@gmail.com', 'phone': '972-4-6304331'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Iyad Magadly', 'oldOrganization': 'Hillel Yaffe Medical Center'}}}}