The aim of this study is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure
ID
Bron
Verkorte titel
Aandoening
Glioma patients with a first epileptic seizure
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
the percentage of patients with ongoing seizure freedom at 6 months
Achtergrond van het onderzoek
Currently, treatment with a specific anti-epileptic drug (AED) mainly depends on the physicians� preference, as there are no randomized controlled trials supporting the use of one specific anticonvulsant in glioma patients. The overall aim of this strategy study is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure. In addition, we aim to examine the level of toxicity, the impact of seizures on HRQoL, cognitive complaints, anxiety/depression, performance status and survival.
Doel van het onderzoek
The aim of this study is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure
Onderzoeksopzet
Follow-up will be maximal 36 months. The timing of outcome assessment will be different for patients with a 3-monthly or 6-monthly follow-up schedule. The first 24 months, patients will be assessed at baseline and subsequently at every follow-up visit. Next, all patients (regardless their follow-up schedule) will be assessed every 6 months.
Onderzoeksproduct en/of interventie
Treatment with (A) levetriacetam, or (B) valproic acid
Publiek
Linda Dirven
Leiden
The Netherlands
l.dirven@lumc.nl
Wetenschappelijk
Linda Dirven
Leiden
The Netherlands
l.dirven@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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: ¡Ý18 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Previously treated with antiepileptic drugs, except emergency treatment in the past 2 weeks
- History of non-brain tumor related epilepsy
- Pregnancy
- History of a status epilepticus
- Presence of contra-indications for use of levetiracetam or valproic acid
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6547 |
| NTR-old | NTR6735 |
| CCMO | NL62477.058.17 |
| OMON | NL-OMON50617 |