]>
IRCT20120215009014N351 IRCT 2020-04-04 Hamedan University of Medical Sciences Effect of levetiracetam monotherapy versus sodium valproate on treatment of children with generalized or focal epilepsy Effect of levetiracetam monotherapy versus sodium valproate on treatment of children with generalized or focal epilepsy: a randomized clinical trial 2019-07-23 anticipated 44 Complete https://irct.ir/trial/46862 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group. 2 Condition 1: Focal epilepsy. Condition 2: Generalized epilepsy. Intervention 1: Intervention group: Levetiracetam syrup (manufactured by Lubel Daru Pharmaceutical Co.) 30 mg/kg every 12 hours for 18 months. Intervention 2: Control group: Sodium valproate syrup (manufactured by Razak Pharmaceutical Co.) 30-30 mg/kg every 12 hours for 18 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situations and the results of the study as well as the approval of the financial supporting organization.
public Dr Ghazal Sami
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 drsami.pediatrician@gmail.com Hamedan University of Medical Sciences scientific Dr. Afshin Fayyazi
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 afshin.fayyazi@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 2 to 18 years, Generalized or focal epilepsy, 2 years 18 years Both False seizures, Sustained brain injury, Acute psychosis, History of cerebral palsy, Pharmaceutic hepatitis, Liver disease, Kidney disease G40.0 G40.3 Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset Generalized idiopathic epilepsy and epileptic syndromes Treatment - Drugs Treatment - Drugs Intervention group: Levetiracetam syrup (manufactured by Lubel Daru Pharmaceutical Co.) 30 mg/kg every 12 hours for 18 months Control group: Sodium valproate syrup (manufactured by Razak Pharmaceutical Co.) 30-30 mg/kg every 12 hours for 18 months Number of seizures. Timepoint: Every month. Method of measurement: By taking history. Blood complications. Timepoint: One month after the intervention. Method of measurement: By checking cell blood count. Hamedan University of Medical Sciences Approved 2019-07-20 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)