Seizure Treatment in Glioma

Last updated: January 31, 2025
Sponsor: Leiden University Medical Center
Overall Status: Active - Recruiting

Phase

4

Condition

Astrocytoma

Cancer/tumors

Brain Cancer

Treatment

Valproic Acid

Levetiracetam

Clinical Study ID

NCT03048084
77353
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 glioblastomaNOS.

  • 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 ofrandomization

  • Willing to provide written informed consent

Exclusion

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 Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Valproic Acid
Phase: 4
Study Start date:
February 01, 2018
Estimated Completion Date:
July 01, 2028

Study 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.

Connect with a study center

  • Amsterdam UMC

    Amsterdam, 1007 MB
    Netherlands

    Suspended

  • VU University Medical Center

    Amsterdam, 1007 MB
    Netherlands

    Active - Recruiting

  • Medisch Spectrum Twente

    Enschede,
    Netherlands

    Active - Recruiting

  • Leiden University Medical Center

    Leiden, 2333 ZA
    Netherlands

    Active - Recruiting

  • Erasmus Medical Center

    Rotterdam, 3008 AE
    Netherlands

    Active - Recruiting

  • Haaglanden Medical Center

    The Hague, 2501 CK
    Netherlands

    Active - Recruiting

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