Levetiracetam Prophylaxis in Brain Tumor Resection Pilot
LeviTaTe Pilot
Pilot Study: Levetiracetam Prophylaxis Randomized Controlled Trial in Brain Tumor Resection
1 other identifier
interventional
70
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2025
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2023
CompletedFirst Posted
Study publicly available on registry
June 9, 2023
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedOctober 23, 2024
October 1, 2024
1 year
April 4, 2023
October 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Recruitment Rate
Feasibility outcome
Through study completion, approximately 1 year
Secondary Outcomes (9)
Fraction of eligible patients approached
Through study completion, approximately 1 year
Fraction of approached patients consent
Through study completion, approximately 1 year
Role of individual who approached patients
Through study completion, approximately 1 year
Protocol adherence
Through study completion, approximately 1 year
Protocol adherence
Through study completion, approximately 1 year
- +4 more secondary outcomes
Other Outcomes (6)
New onset seizure within 7 days of surgery
7 days post-surgery, reviewed at follow-up between post-operative day 8 and 14
Incidence of infection during Study Drug administration
Follow-up between post-operative day 8 and 14
Incidence of psychiatric symptoms during Study Drug Administration
Follow-up between post-operative day 8 and 14
- +3 more other outcomes
Study Arms (2)
Seizure Prophylaxis (Levetiracetam)
EXPERIMENTALLevetiracetam 1 g taken orally twice a day for 7 days
Placebo
PLACEBO COMPARATORPlacebo taken orally twice a day for 7 days
Interventions
Eligibility Criteria
You may qualify if:
- Adult age 18 years or older
- Undergoing craniotomy for a brain tumor
- Intra-axial tumor location
- Supratentorial tumor location
You may not qualify if:
- Documented seizure history or epilepsy diagnosis
- Currently taking an antiepileptic medication
- Unable to take levetiracetam (e.g. allergy, inability to swallow)
- Inability to obtain consent from participant or substitute decision maker prior to surgery
- Renal impairment with eGFR less than 50
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hamilton Health Sciences Corporationlead
- McMaster Universitycollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2023
First Posted
June 9, 2023
Study Start
March 1, 2025
Primary Completion
March 1, 2026
Study Completion
March 1, 2026
Last Updated
October 23, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share