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IRCT2015052022340N1 IRCT 2015-12-26 Vice chancellor for research of Isfahan University of medical sciences Quality of life and seizure control in patients with brain tumor-related epilepsy treated with levetiracetam monotherapy compared by sodium-valproate monotherapy - Clinical trial on comparison of levetiracetam monotherapy and sodium valproate monotherapy on quality of life and seizure control in patients with brain tumor-related epilepsy 2015-05-31 anticipated 23 Complete https://irct.ir/trial/19285 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study randomization will be performed through random number table, assigned to the samples to be divided into two groups. 2-3 brain tumor related epilepsy. Intervention 1: 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. Intervention 2: Intervention group 2: Sodium-valproate starting dose is 200 mg BID, and it is up titrate (200 mg/week) to 1000 – 3000 mg/day, depending on seizure control and tolerability.
public Somayyeh Sadat Teimouri
Kashani comprehensive epilepsy center, Kashani Hospital, Kashani St
Isfahan Iran (Islamic Republic of) 8173888693 +98 313233091 somayyeh.teimouri@gmail.com Isfahan University of Medical Sciences scientific Jafar Mehvari
Kashani comprehensive epilepsy center, Kashani hospital, Kashani St
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 jafarmehvari@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Patients with brain tumors and epilepsy characterized by simple or complex partial seizures, with or without secondary generalization; Patients who had at least one seizure prior to having been referred to our center, who had never undergone prior anti-epileptic drug (AED) therapy; Patients who had received previous AED (with a verification that the previous AEDs had been in the therapeutic range but not controlled; Patients with severe side effects with previous AED therapy. Exclusion criteria: Patients with epilepsy prior to tumor onset; Patient with known sever liver disease for Sodium-Valproate group. 12 years no limit Both G40 Epilepsy Treatment - Drugs Treatment - Drugs 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. Intervention group 2: Sodium-valproate starting dose is 200 mg BID, and it is up titrate (200 mg/week) to 1000 – 3000 mg/day, depending on seizure control and tolerability. Seizure. Timepoint: nomber of seizure attack. Method of measurement: telephon call or visit of patient 0 and 6 month after add patients. Quality of life. Timepoint: Start of the study and 6 months after the start point. Method of measurement: quality of life in epilepsy inventory (QOLIE-31-P). Anxiety. Timepoint: Start of the study and 6 months after the start point. Method of measurement: Beck anxiety inventory (BAI). Depression. Timepoint: Start of the study and 6 months after the start point. Method of measurement: Beck depression inventory (BDI-II). Cognitive function. Timepoint: Start of the study and 6 months after the start point. Method of measurement: mini-mental state examination (MMSE). Blood indices. Timepoint: Start of the study and 6 months after the start point. Method of measurement: Taking blood sample and send to laboratory. Side effects. Timepoint: Monthly. Method of measurement: Interview (in-person and by telephone). Cobel Darou company Vice chancellor for research of Isfahan University of medical sciences Cobel Darou company Approved 2014-10-29 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib St Isfahan Iran (Islamic Republic of)