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Not yet recruiting NCT05897658

Levetiracetam Prophylaxis in Brain Tumor Resection Pilot

Phase III Interventional Seizures Brain Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Levetiracetam, Placebo.
Who it may be relevant to
Registry conditions: Seizures, Brain Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Levetiracetam
    Tablets
  • Other Placebo
    Tablets

Primary outcome measures

  • Recruitment Rate [Time frame: Through study completion, approximately 1 year]
Secondary outcome measures (9)
  • Fraction of eligible patients approached [Time frame: Through study completion, approximately 1 year]
  • Fraction of approached patients consent [Time frame: Through study completion, approximately 1 year]
  • Role of individual who approached patients [Time frame: Through study completion, approximately 1 year]
  • Protocol adherence [Time frame: Through study completion, approximately 1 year]
  • Protocol adherence [Time frame: Through study completion, approximately 1 year]
  • Protocol adherence [Time frame: Through study completion, approximately 1 year]
  • Protocol adherence [Time frame: Through study completion, approximately 1 year]
  • Adverse events [Time frame: Through study completion, approximately 1 year]
  • Unblinding events [Time frame: Through study completion, approximately 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05897658 · 14147

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗