Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-08 @ 10:05 PM
Study NCT ID:
NCT00627133
Status:
WITHDRAWN
Last Update Posted:
2018-06-07
First Post:
2008-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020270', 'term': 'Alcohol Withdrawal Seizures'}], 'ancestors': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020268', 'term': 'Alcohol-Induced Disorders, Nervous System'}, {'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D013375', 'term': 'Substance Withdrawal Syndrome'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077287', 'term': 'Levetiracetam'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'lastUpdateSubmitDate': '2018-06-05', 'studyFirstSubmitDate': '2008-02-20', 'studyFirstSubmitQcDate': '2008-02-28', 'lastUpdatePostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decreased seizures', 'timeFrame': '1, 2, 4, 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alcohol seizure'], 'conditions': ['Seizure, Alcohol Related']}, 'descriptionModule': {'briefSummary': 'Pilot study to evaluate efficacy of Keppra (levetiracetam) for seizure control in patients with alcohol related seizures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No trauma\n* Not pregnant\n* No other cause for seizure (hypoglycemia, CNS causes, trauma)\n* Good family support\n* Working telephone contact\n\nExclusion Criteria:\n\n* Pregnancy\n* Renal failure (creatine \\> 2mg/dl\n* Fever or illness\n* Hypotension\n* Any trauma'}, 'identificationModule': {'nctId': 'NCT00627133', 'briefTitle': 'Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'A Pilot Study Examining the Efficacy of Keppra in Acute Alcohol Related Seizure Control in the Emergency Department Setting', 'orgStudyIdInfo': {'id': 'K17644'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: levetiracetam']}], 'interventions': [{'name': 'levetiracetam', 'type': 'DRUG', 'description': '2 gram iv load, 500mg bid', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'UCB Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Keith Borg MD PhD', 'oldOrganization': 'Medical University of South Carolina'}}}}