RecruitingPhase 4NCT03048084

Seizure Treatment in Glioma

Seizure Treatment in Glioma (STING): Comparing a Treatment Strategy with Levetiracetam Versus Treatment with Valproic Acid in Glioma Patients with a First Seizure

Sponsor

Leiden University Medical Center

Enrollment

120 participants

Start Date

Feb 1, 2018

Study Type

INTERVENTIONAL

Conditions

Glioma

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria4

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

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