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Trial Title:
Levetiracetam Prophylaxis in Brain Tumor Resection Pilot
NCT ID:
NCT05897658
Condition:
Seizures
Brain Tumor
Conditions: Official terms:
Brain Neoplasms
Seizures
Levetiracetam
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Levetiracetam
Description:
Tablets
Arm group label:
Seizure Prophylaxis (Levetiracetam)
Intervention type:
Other
Intervention name:
Placebo
Description:
Tablets
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 2025
Completion date:
March 2026
Lead sponsor:
Agency:
Hamilton Health Sciences Corporation
Agency class:
Other
Collaborator:
Agency:
McMaster University
Agency class:
Other
Source:
Hamilton Health Sciences Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05897658
