Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT05897658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-23
First Post:
2023-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Levetiracetam Prophylaxis in Brain Tumor Resection Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2023-04-04', 'studyFirstSubmitQcDate': '2023-06-01', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'New onset seizure within 7 days of surgery', 'timeFrame': '7 days post-surgery, reviewed at follow-up between post-operative day 8 and 14'}, {'measure': 'Incidence of infection during Study Drug administration', 'timeFrame': 'Follow-up between post-operative day 8 and 14'}, {'measure': 'Incidence of psychiatric symptoms during Study Drug Administration', 'timeFrame': 'Follow-up between post-operative day 8 and 14'}, {'measure': 'Length of hospital stay in days', 'timeFrame': 'Hospital discharge'}, {'measure': 'Incidence of administration of any antiepileptic drugs', 'timeFrame': 'Follow-up between post-operative day 8 and 14'}, {'measure': 'Incidence of administration of any benzodiazepines', 'timeFrame': 'Follow-up between post-operative day 8 and 14'}], 'primaryOutcomes': [{'measure': 'Recruitment Rate', 'timeFrame': 'Through study completion, approximately 1 year', 'description': 'Feasibility outcome'}], 'secondaryOutcomes': [{'measure': 'Fraction of eligible patients approached', 'timeFrame': 'Through study completion, approximately 1 year'}, {'measure': 'Fraction of approached patients consent', 'timeFrame': 'Through study completion, approximately 1 year'}, {'measure': 'Role of individual who approached patients', 'timeFrame': 'Through study completion, approximately 1 year', 'description': 'Description of research team member first approaching and consenting patients (e.g. resident, research staff, staff surgeon, etc.)'}, {'measure': 'Protocol adherence', 'timeFrame': 'Through study completion, approximately 1 year', 'description': 'Number of participants who withdrawal from the study'}, {'measure': 'Protocol adherence', 'timeFrame': 'Through study completion, approximately 1 year', 'description': 'Drug adherence rate'}, {'measure': 'Protocol adherence', 'timeFrame': 'Through study completion, approximately 1 year', 'description': 'Follow-up completion rate'}, {'measure': 'Protocol adherence', 'timeFrame': 'Through study completion, approximately 1 year', 'description': 'Method of follow-up (e.g. telephone, clinic visit)'}, {'measure': 'Adverse events', 'timeFrame': 'Through study completion, approximately 1 year', 'description': 'Serious and related adverse events and adverse drug reactions'}, {'measure': 'Unblinding events', 'timeFrame': 'Through study completion, approximately 1 year', 'description': 'Number of events and reasoning'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Seizures', 'Brain Tumor']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate feasibility of a double-blind randomized controlled trial for levetiracetam prophylaxis for prevention of seizure in the perioperative phase of brain tumor resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult age 18 years or older\n* Undergoing craniotomy for a brain tumor\n* Intra-axial tumor location\n* Supratentorial tumor location\n\nExclusion Criteria:\n\n* Documented seizure history or epilepsy diagnosis\n* Currently taking an antiepileptic medication\n* Unable to take levetiracetam (e.g. allergy, inability to swallow)\n* Inability to obtain consent from participant or substitute decision maker prior to surgery\n* Renal impairment with eGFR less than 50\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05897658', 'acronym': 'LeviTaTe Pilot', 'briefTitle': 'Levetiracetam Prophylaxis in Brain Tumor Resection Pilot', 'organization': {'class': 'OTHER', 'fullName': 'Hamilton Health Sciences Corporation'}, 'officialTitle': 'Pilot Study: Levetiracetam Prophylaxis Randomized Controlled Trial in Brain Tumor Resection', 'orgStudyIdInfo': {'id': '14147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seizure Prophylaxis (Levetiracetam)', 'description': 'Levetiracetam 1 g taken orally twice a day for 7 days', 'interventionNames': ['Drug: Levetiracetam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo taken orally twice a day for 7 days', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Levetiracetam', 'type': 'DRUG', 'description': 'Tablets', 'armGroupLabels': ['Seizure Prophylaxis (Levetiracetam)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Taylor Duda, MD', 'role': 'CONTACT', 'email': 'taylor.duda@medportal.ca', 'phone': '905-521-2100', 'phoneExt': '44155'}, {'name': 'Amanda Martyniuk, MSc', 'role': 'CONTACT', 'email': 'martynia@mcmaster.ca', 'phone': '905-521-2100', 'phoneExt': '44155'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'McMaster University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}