Levetiracetam Prophylaxis in Brain Tumor Resection Pilot

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study: Levetiracetam Prophylaxis Randomized Controlled Trial in Brain Tumor Resection

Conditions
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Seizures, Brain Tumor

Intervention / Treatment
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* Drug: Levetiracetam
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult age 18 years or older Undergoing craniotomy for a brain tumor Intra-axial tumor location Supratentorial tumor location Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seizure Prophylaxis (Levetiracetam)<br>Levetiracetam 1 g taken orally twice a day for 7 days | Drug: Levetiracetam<br>* Tablets<br>|
| Placebo Comparator: Placebo<br>Placebo taken orally twice a day for 7 days | Other: Placebo<br>* Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate | Feasibility outcome | Through study completion, approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Description of research team member first approaching and consenting patients (e.g. resident, research staff, staff surgeon, etc.) | Through study completion, approximately 1 year | 
| Protocol adherence | Number of participants who withdrawal from the study | Through study completion, approximately 1 year | 
| Protocol adherence | Drug adherence rate | Through study completion, approximately 1 year | 
| Protocol adherence | Follow-up completion rate | Through study completion, approximately 1 year | 
| Protocol adherence | Method of follow-up (e.g. telephone, clinic visit) | Through study completion, approximately 1 year | 
| Adverse events | Serious and related adverse events and adverse drug reactions | Through study completion, approximately 1 year | 
| Unblinding events | Number of events and reasoning | Through study completion, approximately 1 year |