NL-OMON50617RecruitingPhase 4
Seizure Treatment IN Glioma (STING): comparing a treatment strategy with levetiracetam versus treatment with valproic acid in glioma patients with a first seizure - Seizure treatment in glioma
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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 4 weeks ago. Also patients with a
- •glioma, who have had tumor-related epilepsy in the past, can be included if
- •they have been seizure-free for >=2 years without the use AEDs
- •- Monotherapy with antiepileptic drugs is considered most appropriate at the
- •time of randomization
- •- Willing to provide written informed consent
Exclusion Criteria
- •- Treated with antiepileptic drugs for the past 2 years, except emergency
- •treatment in the past 4 weeks
- •- History of non-brain tumor related epilepsy
- •- Pregnancy
- •- Presence of contra-indications for use of levetiracetam or valproic acid
Investigators
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