Objectives: To compare quality of life and seizure control in patients with tumor-related epilepsy treated with levetiracetam and sodium-valproate
Design: Randomized controlled trial
Setting and conduct: We will enroll 23 patients by convenience sampling method, divided into two groups of levetiracetam and sodium-valproate randomly. Patients will be asked to fill the following questionnaires before and 6 months after starting their medication: Beck depression inventory (BDI-II), quality of life in epilepsy inventory (QOLIE-31-P), Beck anxiety inventory (BAI), mini-mental state examination (MMSE). They will be interviewed monthly, to evaluate seizure control and adverse effects. Blood tests will also be taken after 6 months.
Major inclusion criteria:
Patients with brain tumors and eplepsy, who had at least one seizure prior to having been referred to our center, and had never undergone prior antiepileptic drug (AED) therapy; or who had received previous AED without response; or with severe side effects with previous AED therapy.
Major exclusion criteria:
Patients with epilepsy prior to tumor onset; or with known severe liver disease.
Intervention:
Group 1: Levetiracetam starting dose is 250 mg BID and it is up titrated (500 mg/week) to 1.000– 3.000 mg/day, depending on seizure control and tolerability.
Group 2: Sodium-valproate starting dose is 200 mg BID, and it is up titrated (200 mg/week) to 1000 – 3000 mg/day, depending on seizure control and tolerability.
Main outcome measures:
Quality of life, anxiety, depression, cognitive function, seizure control, neurological examination, and adverse effects are outcome variables that are measured and compared between two groups.