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IRCT2015030821355N1 IRCT 2017-01-12 Mashhad University of Medical Sciences levetiracetam versus carbamazepine monotherapy in the treatment of focal epilepsy of children levetiracetam versus carbamazepine monotherapy in the treatment of focal epilepsy of children 2014-07-02 anticipated 50 Complete https://irct.ir/trial/18738 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Epilepsy. Intervention 1: Control Group: carbamazepine group: This group will be treated with carbamazepine. In carbamazepine group,the drug with the dose of 5 mg/kg/day is initiated and increases 5 mg/kg/week. finlay, it reaches to the current dose of 15 mg/kg/per day. Then, with the same dose, the drug continues. Intervention 2: Intervention Group: levetiracetam group: This group will be treated with levetiracetam. In levetiracetam group,the drug with the dose of10 mg/kg per day is initiated and increases 10 mg/kg/week . finlay, it reaches to the current dose of30 mg/kg/per day. Then, with the same dose, the drug continues.
public Hosein Eslamiyeh
Ghaem Hospital
Mashhad Iran (Islamic Republic of) +98 51 3854 3031 Eslamieh@ssu.ac.ir Mashhad University of Medical Sciences scientific Hosein Eslamiyeh
Ghaem hospital, Ahmad abad
Mashhad Iran (Islamic Republic of) +98 51 3854 3031 Eslamieh@ssu.ac.ir Ghaem hospital Iran (Islamic Republic of) Inclusion criteria: Children with age over one year and less than sixteen years old with newly diagnosed focal epilepsy, No history of refractory seizures, No history of renal disease, No history of hepatic disease, No history of cerebral palsy, No history of antiepileptic drug consumption. Exclusion criteria: Pseudo- seizures, Skin rash especially Stevens Johnson syndrome, Drug-induced hepatitis, Acute psychosis, Renal disorders, Severe agitation, any other mild side effects that is unbearable to the patient or parents 1 year 16 years Both G40 Episodic diseases Treatment - Drugs Treatment - Drugs Control Group: carbamazepine group: This group will be treated with carbamazepine. In carbamazepine group,the drug with the dose of 5 mg/kg/day is initiated and increases 5 mg/kg/week. finlay, it reaches to the current dose of 15 mg/kg/per day. Then, with the same dose, the drug continues. Intervention Group: levetiracetam group: This group will be treated with levetiracetam. In levetiracetam group,the drug with the dose of10 mg/kg per day is initiated and increases 10 mg/kg/week . finlay, it reaches to the current dose of30 mg/kg/per day. Then, with the same dose, the drug continues. Occurence of seizure. Timepoint: Six months from the beginning of study. Method of measurement: Desciption of patients and parents. Rise of liver enzymes. Timepoint: One month after beginning of the study. Method of measurement: Measurment of AST and ALT. Skin rash. Timepoint: In the six month from the beginning of the study. Method of measurement: Observation. Agitation. Timepoint: In the six month from the beginning of the study. Method of measurement: Parents report. Somnolence. Timepoint: In the six month from the beginning of the study. Method of measurement: Parents report. Advers blood effects. Timepoint: One montn after beginning of study. Method of measurement: CBC examination. Mashhad University of Medical Sciences Approved 2013-12-03 Ehics comittee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Vakil abad Mashhad Iran (Islamic Republic of)