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IRCT2014083018973N1 IRCT 2015-09-26 Deputy for research affairs of Shahrekord University of Medical Scince Compare valproate Sodium and Levetiracetam effects on epilepsy Effect of Levetiracetam mono therapy in comparison with Sodium Valproate on juvenile myoclonic epilepsy 2014-06-21 anticipated 20 Complete https://irct.ir/trial/17085 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Epilepsy. Intervention 1: case group will be treated with 250 mg LEV tablet and the drug dose will be increased until the patient will be seizure free. The maximum dose of LEV is 2500mg daily. Intervention 2: The control group will be treated with 10-15 mg/kg sodium valporate and the drug dose will be increased until the patient will be seizure free. The maximum dose of sodium valporate is 30-60 mg/kg.
public Dr Jafar Mehvari
Epilepsy clinic, Kashani Hospital of Isfahan, Kashani Avn, Isfahan, Iran
Isfahan Iran (Islamic Republic of) +98 31 3777 2833 Jafarmehvari@med.mui.ac.ir Isfahan University of Medical Scince scientific Dr Jafar Mehvari
Epilepsy clinic, Kashani hospital of Isfahan, Kashani Avn, Isfahan, Iran
Isfahan Iran (Islamic Republic of) +98 31 3777 2833 Jafarmehvari@med.mui.ac.ir Isfahan University of Medical Scince Iran (Islamic Republic of) Inclusion criteria included patients how have JME (Juvenile Myoclonic epilepsy ) with two myoclonus and no EEG changes; or a Myoclonus with EEG changes, which this changes include specific changes (3-6Hz spike / polyspike slow wave discharge); epilepsy should start at 8 to 25 years old. The exclusion criteria included, neurological disorders; mental disorder; history of pseudoseizures; history of mental or mood disorder; the use of drugs affecting the central nervous system in a month before beginning of the study; metabolic disorders; infectious disease; malignancy; pregnancy and disease that their treatment interact with valproate sodium or Leveteracetam. 8 years 25 years Both G40.3 Generalized idiopathic epilepsy and epileptic syndromes Treatment - Drugs Treatment - Drugs case group will be treated with 250 mg LEV tablet and the drug dose will be increased until the patient will be seizure free. The maximum dose of LEV is 2500mg daily. The control group will be treated with 10-15 mg/kg sodium valporate and the drug dose will be increased until the patient will be seizure free. The maximum dose of sodium valporate is 30-60 mg/kg. Electro encephalo gram (EEG) changes. Timepoint: Before, 3 mounths and 6 mounths after inital treatment. Method of measurement: Electro encephalo gram (EEG) that is taken by EEG machine. This changes contains 3-6 Hz Bilateral spike/polyspike slow wave discharge. Count of seizures after treatment. Timepoint: After ending the period of treating (6 mounths after initial treatment). Method of measurement: According to patients and thier fellows history. Count of myoclonus after treatment. Timepoint: 3 and 6 mounths after initial treatment. Method of measurement: According to patients and thier fellows history. Sodium valporate side effects, that contains Asthenia, Headache, Smnolence, Cough, Nervousness, Amnesia, Ataxia, Depression, Nuasea, Vomiting, Tremor, Alopesia, Diziness, Dyspepsia, Rash, Weight Gain, Increase or decrease of appetite. Timepoint: 3 and 6 mounths after initial treatment. Method of measurement: According to asking from patient and chek list. Leveteracetam side effects that contains Asthenia, Headache, Smnolence, Cough, Nervousness, Amnesia, Ataxia, Depression, Nuasea, Vomiting, Tremor, Alopesia, Diziness, Dyspepsia, Rash, Weight Gain, Increase or decrease of appetite. Timepoint: 3 and 6 mounths after initial treatment. Method of measurement: According to asking from patient and chek list. Deputy for research affairs of Shahrekord University of Medical Scince Approved 2014-05-23 Shahrekord University of Medical Science Headquarter of Shahrekord University of Medical Scince, Kashani Avn, Shah re-kord, Iran Shahrekord Iran (Islamic Republic of)