No registrations found.
ID
Source
Brief title
Health condition
Glioma patients with a first epileptic seizure
Sponsors and support
Intervention
Outcome measures
Primary outcome
the percentage of patients with ongoing seizure freedom at 6 months
Secondary outcome
- time to 6 month seizure freedom
- seizure outcome at 12 months
- level of toxicity and hospitalization rate due to treatment failure
- impact of seizures on HRQoL, cognitive complaints, anxiety/depression and performance status
- burden of epilepsy
- treatment response (e.g., maximum dosage of AED, use of add-on AED).
- progression-free and overall survival
- burden of epilepsy
- treatment response (e.g., maximum dosage of anti-epileptic drug, use of add-on anti-epileptic drug).
- progression-free and overall survival
Background summary
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.
Study objective
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
Study design
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.
Intervention
Treatment with (A) levetriacetam, or (B) valproic acid
Linda Dirven
Leiden
The Netherlands
l.dirven@lumc.nl
Linda Dirven
Leiden
The Netherlands
l.dirven@lumc.nl
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: ¡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
Exclusion criteria
- 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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6547 |
| NTR-old | NTR6735 |
| CCMO | NL62477.058.17 |
| OMON | NL-OMON50617 |