Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:33 PM
Study NCT ID:
NCT07490769
Status:
RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levetiracetam Three Times Daily in Epilepsy
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-22', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-22', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'mean change in QoL', 'timeFrame': '6 and 12 months post intervention', 'description': 'The mean change from baseline in quality of life (unit: QOLIE-31 total score, range 0-100) will be measured and compared in patients with epilepsy during treatment with Levetiracetam administered three times daily versus twice daily (self-controlled comparison). Quality of life will be assessed using the Quality of Life in Epilepsy-31 (QOLIE-31) questionnaire, a validated patient-reported outcome measure.'}], 'primaryOutcomes': [{'measure': 'change in mean number of Seizure-free days', 'timeFrame': 'within 6 months pre and post interventions', 'description': 'The mean number of seizure-free days (unit: days), defined as calendar days without any reported seizure events, will be measured and compared in patients with epilepsy during treatment with Levetiracetam administered three times daily versus twice daily (self-controlled comparison). Seizure-free days will be assessed using a patient-reported seizure diary (standardized daily seizure log)'}], 'secondaryOutcomes': [{'measure': '% Adverse events', 'timeFrame': '12 month post interventions', 'description': 'the percent frequency of Levetiracetam adverse events (agitation, behaviors, psychiatric, dizziness, headache, and other AE reported by participants) between the three times daily versus twice daily of Levetiracetam in patients with epilepsy. Levetiracetam adverse events assessed using a patient-reported seizure diary (standardized daily seizure log)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Levetiracetam', 'TID', 'Epilepsy'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to evaluate the efficacy and tolerability of Levetiracetam administered three times daily in patients with epilepsy. The primary objective is to investigate whether orally administered Levetiracetam three times daily dosing is superior in seizure-free days compared to standard twice-daily dosing in patients with epilepsy.\n\nKey questions include:\n\n* Does LEV improve seizure control, as measured by seizure-free days?\n* What adverse events or safety concerns are observed with LEV treatment?\n\nParticipants will receive Levetiracetam administered three times daily during the treatment phase. The study will use a self-matched, pre-post design in which each participant serves as their own control. Baseline seizure activity and safety data will be collected prior to LEV initiation and compared with data obtained during the treatment period. Participants will attend scheduled clinic visits for efficacy and safety evaluations and will maintain a daily diary to record seizure frequency and any treatment-related events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older.\n* diagnosed with uncontrolled Epilepsy of any type (defined as one or more unprovoked seizures in the last 6 months)\n* On Levetiracetam monotherapy\n* Participants must have a documented history of Levetiracetam use for at least 12 months prior to enrollment.\n* on Levetiracetam high dose (1.5 - 3 g daily)\n\nExclusion Criteria:\n\n* Younger than Aged 18 years\n* Received Levetiracetam intravenous within the last 24hr.\n* Co-administered with other antiepileptic drugs\n* Received other antiepileptic drugs in the last two weeks.\n* Pregnant women.\n* Renal impairment (Crcl \\< 30) or Acute kidney injury'}, 'identificationModule': {'nctId': 'NCT07490769', 'acronym': 'LEVTID', 'briefTitle': 'Levetiracetam Three Times Daily in Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'King Saud University'}, 'officialTitle': 'Evaluating Efficacy and Tolerability of Three Times Daily Levetiracetam in Epilepsy Patients', 'orgStudyIdInfo': {'id': 'SCTR25011502'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Levetiracetam BID', 'description': 'Levetiracetam (750mg - 1500 mg) oral tablet twice times a day for 12 months', 'interventionNames': ['Drug: Levetiracetam']}], 'interventions': [{'name': 'Levetiracetam', 'type': 'DRUG', 'description': 'Levetiracetam oral (500mg - 1000 mg) tablet three times a day for 12 months', 'armGroupLabels': ['Levetiracetam BID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13321', 'city': 'Riyadh', 'state': 'Riyadh Region', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'King Saud University King Saud University', 'role': 'CONTACT', 'email': 'submitCTU@ksu.edu.sa', 'phone': '+966114670011'}, {'name': 'Waad H Alkathiri, PhD Candidate', 'role': 'CONTACT', 'email': 'waad-alkathiri@hotmail.com'}, {'name': 'Waad H Alkathiri, PhD candidate', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Saeed A Alqahtani, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bandar N Aljafen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bandar S Balkhi, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fatimah Alotaibi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'King Saud University', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'confidentiality agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Waad Alkathiri', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacist', 'investigatorFullName': 'Waad Alkathiri', 'investigatorAffiliation': 'King Saud University'}}}}