Health TrialsbyHealthPanel

Seizure Treatment in Glioma

ConditionGlioma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeiden University Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Levetiracetam

    Drug

    Antiepileptic drug levetiracetam

  • Valproic Acid

    Drug

    Antiepileptic drug valproic acid

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: LevetiracetamActive comparator 1 intervention
Group B: Valproic acidActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ongoing seizure freedom at 6 months

The percentage of patients with ongoing seizure freedom at 6 months

Time frame
6 months

Secondary outcomes

1

Cumulative incidence of treatment failure for any reason

Cumulative incidence function of time to treatment failure for any reason of ASM treatment using competing risk models with death as a competing event.

Time frame
36 months
2

Cumulative incidence of treatment failure for specific reasons

Cumulative incidence function of time to treatment failure for specific reasons of ASM treatment using competing risk models with death and non-applicable reasons of failure as competing events. Reasons of failure: uncontrolled seizures, adverse effects, other reasons of treatment failure, and death

Time frame
36 months
3

Cumulative incidence of a first recurrent seizure

Cumulative incidence function of time to occurrence of a first recurrent seizure after ASM initiation using competing risk models with death as a competing event.

Time frame
36 months
4

Adverse effects of the treatment

Severity of adverse effects of the treatment, defined as severity (grade 1-5) of intolerable adverse effects leading to ASM discontinuation according to the Common Terminology Criteria for Adverse- Events (CTCAE) version 5.0

Time frame
0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively

Other outcomes

Sponsors and contacts

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Leiden University Medical Center

Lead sponsor

Medical Center Haaglanden

Collaborator

Erasmus Medical Center

Collaborator

Amsterdam UMC, location VUmc

Collaborator

Source ClinicalTrials.gov
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