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Seizure Treatment in Glioma

Seizure Treatment in Glioma

Recruiting
18 years and older
All
Phase 4

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Overview

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.

Description

Currently, treatment of glioma patients with a specific anti-epileptic drug (AED) mainly depends on the physicians' preference, as there is no robust evidence from randomized controlled trials supporting the use of one specific anticonvulsant above the other in glioma patients.

Levetiracetam and valproic acid are the most commonly used AEDs in glioma patients. Both drugs are used for the treatment of seizures, have similar toxicity profiles and are non-enzyme inducing AEDs, therefore not interfering with chemotherapeutic drugs. However, it is not known whether one drug is more effective than the other in reducing seizures.

Eligibility

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

Study details
    Glioma

NCT03048084

Leiden University Medical Center

20 March 2024

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