Levetiracetam Prophylaxis in Brain Tumor Resection Pilot (LeviTaTe Pilot)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Seizures; Brain Tumor
• Intervention / Treatment: Other: Placebo; Drug: Levetiracetam

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Amanda Martyniuk, MSc; Phone Number: 44155 905-521-2100; Email: martynia@mcmaster.ca
• Study Contact Backup: Name: Taylor Duda, MD; Phone Number: 44155 905-521-2100; Email: taylor.duda@medportal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
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
Length of hospital stay in days	Hospital discharge
Incidence of administration of any antiepileptic drugs	Follow-up between post-operative day 8 and 14
Incidence of administration of any benzodiazepines	Follow-up between post-operative day 8 and 14

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: McMaster University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Central Nervous System Neoplasms; Nervous System Neoplasms; Seizures; Brain Neoplasms; Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: 14147

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No