Levetiracetam Prophylaxis in Brain Tumor Resection Pilot

NCT ID: NCT05897658

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-03-31

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.

Detailed Description

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Conditions

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Seizures Brain Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Seizure Prophylaxis (Levetiracetam)

Levetiracetam 1 g taken orally twice a day for 7 days

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

Tablets

Placebo

Placebo taken orally twice a day for 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Tablets

Interventions

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Levetiracetam

Tablets

Intervention Type DRUG

Placebo

Tablets

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Taylor Duda, MD

Role: CONTACT

905-521-2100 ext. 44155

Amanda Martyniuk, MSc

Role: CONTACT

905-521-2100 ext. 44155

Other Identifiers

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14147

Identifier Type: -

Identifier Source: org_study_id

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