Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-01-02 @ 1:28 AM
Study NCT ID:
NCT01115959
Status:
COMPLETED
Last Update Posted:
2014-06-12
First Post:
2010-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Seizures Post Intracerebral Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-11', 'studyFirstSubmitDate': '2010-05-02', 'studyFirstSubmitQcDate': '2010-05-02', 'lastUpdatePostDateStruct': {'date': '2014-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of seizures', 'timeFrame': 'study drug for 1 month and 1 year follow up'}], 'secondaryOutcomes': [{'measure': 'neurological outcome NIHSS', 'timeFrame': 'during 1 month study drug and 1 year post follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Post Cerebral Hemorrhage']}, 'descriptionModule': {'briefSummary': 'This study examines early antiepileptic treatment with valproic acid for acute cerebral hemorrhage against a placebo group immediately post event to evaluate the outcome of these patients regarding seizures and neurological outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cerebral hemorrhage spontaneous\n\nExclusion Criteria:\n\n* early seizures'}, 'identificationModule': {'nctId': 'NCT01115959', 'briefTitle': 'Seizures Post Intracerebral Hemorrhage', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'Are Post Intracerebal Hemorrhage Prevented By Anti-Epileptic Treatment?', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'valproic acid', 'description': 'Valproic acid given orally 400mg twice daily', 'interventionNames': ['Drug: valproic acid', 'Drug: placebo bid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo twice daily for one month', 'interventionNames': ['Drug: placebo bid']}], 'interventions': [{'name': 'valproic acid', 'type': 'DRUG', 'description': 'treatment of 1 month dosage of 400 mg BID', 'armGroupLabels': ['valproic acid']}, {'name': 'placebo bid', 'type': 'DRUG', 'armGroupLabels': ['placebo', 'valproic acid']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'ronit gilad, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'E Wolfson med center'}, {'name': 'ronit gilad, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'E wofson med center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Yair Lampl', 'investigatorFullName': 'Dr. Yair Lampl', 'investigatorAffiliation': 'Wolfson Medical Center'}}}}