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IRCT20170216032603N2 IRCT 2020-06-19 Alborz University of Medical Sciences Analysis of the efficacy and side effects of Levetiracetam and Carbamazepine on treatment of children's epilepsy Comparison between the efficacy and side effects of Levetiracetam versus Carbamazepine as mono therapy in treatment of partial epilepsy of the children between 2 to 14 years old 2020-02-02 anticipated 120 Complete https://irct.ir/trial/44705 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients admitted or referred to the clinic will be divided into two groups based on the last digit of their file numbers. Patients with even last digit of file numbers will be in intervention group and patients will odd last digit of file numbers will be in control group. Intervention group will be treated by Levetiracetam and control group will be treated by Carbamazepine, Blinding description: The patients and the statistical analyzer were unaware of the drug used in each group. 2-3 Partial Epilepsy. Intervention 1: Intervention group: The intervention group will be treated with Levetiracetam drug. The drug is started at a dose of 10 mg/kg per day and is increased by 10 mg/kg per week to reach the usual dose of 30 mg/kg per day. The maximum dose in these patients was 40 mg/kg. Then continue with the same dose. Intervention 2: Control group: The control group treated with Carbamazepine started with a dose of 5 mg/kg per day and increased by 5 kg/kg per week to reach the usual dose of 15 mg/kg. The maximum dose in these patients was 20 mg/kg. Then continue with the same dose. Yes - There is a plan to make this available What will be shared: All collected information can be shared When: After the publication of results To whom: People working in academic institutions Conditions: Our data can be used with our permissions in academic classes Where to obtain: Hadi Montazerlotfelahi with E-mail: h-mlotfelahi@razi.tums.ac.ir How to obtain: After a month we can share the data after complete understanding of aims Comments:
public Hadi Montazer Lotfelahi
After University of Art, West Bu Ali St., Nabovat Sq.
Karaj Iran (Islamic Republic of) 3149969415 +98 26 3428 7339 hmontazer.hadi@yahoo.com Alborz University of Medical Sciences scientific Hadi Montazer Lotfelahi
After University of Art, West Bu Ali St., Nabovat Sq.
Karaj Iran (Islamic Republic of) 3149969415 +98 26 3428 7339 hmontazer.hadi@yahoo.com Alborz University of Medical Sciences Iran (Islamic Republic of) 2-14 years old Partial epilepsy as a new onset No history of renal disease No history of liver disease No history of cerebral palsy Acceptance to be part of this study 2 years 14 years Both Epilepsy in patients with any brain damage from three month ago History of taking any anti-epileptic medications History of liver disease History of renal disease History of neurological disease under medical treatment G40 Epilepsy and recurrent seizures Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will be treated with Levetiracetam drug. The drug is started at a dose of 10 mg/kg per day and is increased by 10 mg/kg per week to reach the usual dose of 30 mg/kg per day. The maximum dose in these patients was 40 mg/kg. Then continue with the same dose. Control group: The control group treated with Carbamazepine started with a dose of 5 mg/kg per day and increased by 5 kg/kg per week to reach the usual dose of 15 mg/kg. The maximum dose in these patients was 20 mg/kg. Then continue with the same dose. Medicine's Side Effects. Timepoint: Week 4, 12, 24 and if seizure or any side effects occur. Method of measurement: History and laboratory test result. Alborz University of Medical Sciences Approved 2020-02-02 Ethics committee of Alborz University of Medical Sciences After University of Art, West Bu Ali St., Nabovat Sq. Karaj Alborz Iran (Islamic Republic of)