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IRCT20181014041338N1 IRCT 2022-01-16 Shiraz University of Medical Sciences Comparison between the effect of carbamazepine and levetiracetam on children diagnosed with Rolandic epilepsy Comparison between the effect of carbamazepine and levetiracetam usage in the treatment of children between 6 to 12 years old with Rolandic epilepsy; An open-labeled RCT 2021-10-22 anticipated 88 Complete https://irct.ir/trial/58063 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using Excel software and the Rand function in the software, the statistician of the project, will create a random sequence and hide this randomized allocation before the interventions begin. In this sequence, participants were randomly entered into 22 blocks, each consisting of two girls and two boys (each block consist of 4 individuals), in random order. Then 11 blocks would be given carbamazepine and another 11 blocks would receive levetiracetam. N/A patient diagnosed with Rolandic syndrome. Intervention 1: Control group: receiving Carbamazepine drug, Carbamazepine tab 200 mg (© Galinus Pharmaceuticals) within daily administration of 15-20 mg/kg maintenance dosage. Intervention 2: Intervention group: receiving Levetiracetam, Levetiracetam tab 250 or 500 mg (© Cobel Darou) within daily administration of 50 mg/kg maintenance dosage. Yes - There is a plan to make this available What will be shared: Demographic data and data related to final outcome will be shared by maintaining confidentiality. When: De-identified data will be available starting 1 year after publication. To whom: Academics employed at various research/university institutions and affiliated industries. Conditions: For Academic and research goals only. Where to obtain: Hamid Nemati, Imam Reza clinic, Namazi sq, shiraz meshham5@gmail.com How to obtain: The applicant would be asked to provide a formal request letter containing the importance of the data and the project processes. Following the receipt of the request letter, the data would be provided maxim within 1 month. Comments:
public Hamid Nemati
Imam Reza Clinic, Namazi Sq, shiraz, fars.
shiraz Iran (Islamic Republic of) 7134814734 +98 71 3212 7000 meshham5@gmail.com Shiraz University of Medical Sciences scientific Hamid Nemati
Imam Reza Clinic, Namazi Sq, shiraz, fars.
shiraz Iran (Islamic Republic of) 7134814734 +98 71 3212 7000 meshham5@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) children between age 6-12 years old (age of onset of disorder and eligible for the cognitive test) diagnosed with Rolandic syndrome by using vEEG or EEG by a pediatric neurologist or epileptologist having no previous history of using AEDs (Anti-epileptic drugs) having no previous history of neurological and/or psychiatric and/or learning and/or genetical disorder(s) previous to the onset of Rolandic syndrome having no history of using drugs that affect cognitive abilities significantly signing ethical consent with total awareness and voluntary 6 years 12 years Both patients who showed any side effects of Carbamazepine (like skin rash, Steven Johnson) and Levetiracetam (like suicide thoughts, acute behavioral problems due to Levetiracetam usage) G40.0 Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset Treatment - Drugs Treatment - Drugs Control group: receiving Carbamazepine drug, Carbamazepine tab 200 mg (© Galinus Pharmaceuticals) within daily administration of 15-20 mg/kg maintenance dosage. Intervention group: receiving Levetiracetam, Levetiracetam tab 250 or 500 mg (© Cobel Darou) within daily administration of 50 mg/kg maintenance dosage. Rate of preventing epilepsy attacks. Timepoint: before the drug usage and 2 weeks, 1 and 3 months after the drug usage. Method of measurement: recording the number of epilepsy attacks viewed by family. Cognitive test score. Timepoint: before the intervention and 3 months after it. Method of measurement: using WISC 5 TEST. Shiraz University of Medical Sciences Approved 2021-08-07 Ethics committee of shiraz University of Medical Sciences Zand St., Shiraz, Iran shiraz Fars Iran (Islamic Republic of)