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IRCT20190208042654N3 IRCT 2020-01-07 Esfahan University of Medical Sciences The Comparison of efficacy of Levetiracetam and Carbamazepine in the treatment of Rolandic seizures in children A comparative study on the efficacy of Levetiracetam and Carbamazepine in the treatment of Rolandic seizures in children referred to the pediatric neurology clinics of Imam Hossein hospital- Isfahan University of Medical Sciences in 2019; An open-label randomized controlled trial 2019-10-12 anticipated 94 Complete https://irct.ir/trial/44791 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total of 94 patients will be selected consecutively, if they meet the criteria for entry, from the patients admitted to the neurology clinic of Imam Hossein children hospital. Then, they are assigned randomly to two groups by binary blocks. The randomization process is done by using a random numbered table to reach the desired sample number. 3 Rolandic seizure. Intervention 1: Intervention group: Levetiracetam group treated with Lovebel syrup (100 mg/ml) with 30 mg/kg/day for 6 months. Intervention 2: Control group: Carbamazepine group treated with Tegertol 20 mg/kg for 6 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 is not yet known if there will be a plan to make this available
public Jafar Nasiri
Emam Khomeini Ave
Isfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 Nasiri.jafar@gmail.com Esfahan University of Medical Sciences scientific Jafar Nasiri
Emam Khomeini Ave
Isfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 Nasiri.jafar@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children with BECTS (clinical diagnosis and EEG in favor of Rolandic epilepsy) with more than two attacks per year Medicated with only one drug Age above 4 years under 12 years and Normal MRI 4 years 12 years Both Lack of consent to enter the study Severe side effects and drug reactions to Levetiracetam or Carbamazepine Multi-drug therapy Inability to follow up the patients G40 Epilepsy and recurrent seizures Treatment - Drugs Treatment - Drugs Intervention group: Levetiracetam group treated with Lovebel syrup (100 mg/ml) with 30 mg/kg/day for 6 months Control group: Carbamazepine group treated with Tegertol 20 mg/kg for 6 months Frequency, duration, and severity of seizure attacks and drug side effects. Timepoint: before treatment and every two months for 6 months. Method of measurement: Questionnaire. Esfahan University of Medical Sciences Approved 2019-10-09 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib Ave Isfahan Isfehan Iran (Islamic Republic of)