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RECRUITING Phase 4 ClinicalTrials.gov

Seizure Treatment in Glioma

Sponsor: Leiden University Medical Center • ClinicalTrials.gov ID: NCT03048084

Registry updated: 2026-08-26
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Description

Currently, treatment with a specific anti-epileptic drug mainly depends on the physicians' preference, as there are no studies supporting the use of one specific anticonvulsant in glioma patients. The overall aim of this randomized controlled trial is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure.

Interventions

  • Levetiracetam (Drug)
    Antiepileptic drug levetiracetam
  • Valproic Acid (Drug)
    Antiepileptic drug valproic acid

Eligibility criteria

Inclusion Criteria: * Histologically proven or suspected diffuse astrocytoma (Isocytrate Dehydrogenase-1 (IDH-1) wildtype or IDH-1 mutated), diffuse oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), anaplastic astrocytoma (IDH-1 wildtype or IDH-1 mutated), anaplastic oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), glioblastoma (IDH-1 wild-type or IDH-1 mutated), or diffuse astrocytoma not otherwise specified (NOS), anaplastic astrocytoma NOS, oligodendroglioma NOS, oligoastrocytoma NOS, anaplastic oligoastrocytoma NOS, anaplastic oligodendroglioma NOS or glioblastoma NOS. * Adult patients: ≥18 years of age * First epileptic seizure, no longer than 2 weeks ago * Monotherapy with antiepileptic drugs is considered most appropriate at the time of randomization * Willing to provide written informed consent Exclusion Criteria: * Previously treated with antiepileptic drugs, except emergency treatment in the past 2 weeks * History of non-brain tumor related epilepsy * Pregnancy * Presence of contra-indications for use of levetiracetam or valproic acid

Conditions

Glioma

Locations

  • Amsterdam UMC — Amsterdam, Netherlands
  • Medisch Spectrum Twente — Enschede, Netherlands
  • Leiden University Medical Center — Leiden, Netherlands
  • Erasmus Medical Center — Rotterdam, Netherlands
  • Haaglanden Medical Center — The Hague, Netherlands
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record