Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:01 PM
Study NCT ID:
NCT07422233
Status:
COMPLETED
Last Update Posted:
2026-02-19
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Levetiracetam's Effectiveness and Tolerability for Treating Epilepsy in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seizure free rate', 'timeFrame': '12 months', 'description': 'The rate of patients who stayed seizure-free after drug initiation'}, {'measure': 'Retention rate', 'timeFrame': '12 months', 'description': 'The rate of patients who continue taking drug'}, {'measure': 'Time to first seizure', 'timeFrame': 'at occurrence of first seizure', 'description': 'The interval between starting drug and recurrence of seizure'}, {'measure': 'Time to withdrawal', 'timeFrame': 'the day that the patient stops taking drug', 'description': 'The interval between starting drug and stoping its use'}], 'secondaryOutcomes': [{'measure': 'Tolerability rate', 'timeFrame': '12 months', 'description': 'the rate of patients that forfeit participation in the study due to adverse effects'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy', 'Elderly']}, 'descriptionModule': {'briefSummary': 'This prospective interventional study was conducted between 2023 and 2025 at the Department of Neurology of Bouali Sina Hospital. Consecutive elderly patients presenting with epilepsy were screened for eligibility. The diagnosis of epilepsy was confirmed by the treating neurologist. The patients underwent treatment with levetiracetam. Primary and secondary outcomes were investigated as was explained before.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥60 years\n2. Diagnosis of epilepsy\n\nExclusion Criteria:\n\n1. Chronic kidney disease requiring dialysis\n2. History of psychotic disorders or current use of anxiolytic, antidepressant, or antipsychotic medications\n3. Current use of antiseizure medications for any reason'}, 'identificationModule': {'nctId': 'NCT07422233', 'acronym': 'LEVEL', 'briefTitle': "Evaluation of Levetiracetam's Effectiveness and Tolerability for Treating Epilepsy in Older Adults", 'organization': {'class': 'OTHER', 'fullName': 'Mazandaran University of Medical Sciences'}, 'officialTitle': 'Investigation of Efficacy and Tolerability of Levetiracetam for Epilepsy in Elderly', 'orgStudyIdInfo': {'id': '11402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Levetiracetam', 'description': 'Elderly patients with epilepsy who have received levetiracetam', 'interventionNames': ['Drug: Oral levetiracetam']}], 'interventions': [{'name': 'Oral levetiracetam', 'type': 'DRUG', 'description': 'Treatment with levetiracetam tablets', 'armGroupLabels': ['Levetiracetam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4815733971', 'city': 'Sari', 'state': 'Mazandaran', 'country': 'Iran', 'facility': 'Mazandaran University of medical sciences', 'geoPoint': {'lat': 36.56332, 'lon': 53.06009}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'If requested in certain circumstances.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nasim Tabrizi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor of neurology', 'investigatorFullName': 'Nasim Tabrizi', 'investigatorAffiliation': 'Mazandaran University of Medical Sciences'}}}}