Levetiracetam Prophylaxis in Brain Tumor Resection Pilot

Phase 3

Not yet recruiting

• Conditions: Seizures; Brain Tumor
• Interventions: Other: Placebo; Drug: Levetiracetam

• Registration Number: NCT05897658
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Study Start: 2025-03
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo taken orally twice a day for 7 days
Seizure Prophylaxis (Levetiracetam)	Levetiracetam	Levetiracetam 1 g taken orally twice a day for 7 days

Primary Outcome Measures

Name	Time	Method
Recruitment Rate	Through study completion, approximately 1 year	Feasibility outcome

Secondary Outcome Measures

Name	Time	Method
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	Description of research team member first approaching and consenting patients (e.g. resident, research staff, staff surgeon, etc.)
Protocol adherence	Through study completion, approximately 1 year	Method of follow-up (e.g. telephone, clinic visit)
Adverse events	Through study completion, approximately 1 year	Serious and related adverse events and adverse drug reactions
Unblinding events	Through study completion, approximately 1 year	Number of events and reasoning