Seizure Treatment in Glioma

ClinicalTrials.gov ID

NCT03048084

Lead Sponsor

Leiden University Medical CenterOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

120Estimated

Last Update Posted

Aug 26, 2026Actual

Start Date

Feb 1, 2018Actual

Primary Completion Date

Jan 1, 2028Estimated

Completion Date

Jul 1, 2029Estimated

Official Title

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

Brief 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.

Detailed 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.

• Glioma

• Levetiracetam
• Valproic Acid

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Leiden University Medical CenterOTHER

Collaborators

Medical Center HaaglandenOTHER

Erasmus Medical CenterOTHER

Amsterdam UMC, location VUmcOTHER

j.a.f.koekkoek@lumc.nl0031715269111

j.jongen@erasmusmc.nl0031107040704

l.fritz@haaglandenmc.nl0031703302000

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