A study comparing two anti-epileptic drugs in glioma patients with a first seizure
- Conditions
- Glioma patients with a first epileptic seizure
- Registration Number
- NL-OMON22812
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
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
-Previously treated with antiepileptic drugs, except emergency treatment in the past 2 weeks
-History of non-brain tumor related epilepsy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the percentage of patients with ongoing seizure freedom at 6 months
- Secondary Outcome Measures
Name Time Method -time to 6 month seizure freedom<br /><br>-seizure outcome at 12 months <br /><br>-level of toxicity and hospitalization rate due to treatment failure<br /><br>-impact of seizures on HRQoL, cognitive complaints, anxiety/depression and performance status<br /><br>-burden of epilepsy<br /><br>-treatment response (e.g., maximum dosage of AED, use of add-on AED).<br /><br>-progression-free and overall survival<br /><br>-burden of epilepsy<br /><br>-treatment response (e.g., maximum dosage of anti-epileptic drug, use of add-on anti-epileptic drug).<br /><br>-progression-free and overall survival