MedPath

Compare valproate Sodium and Levetiracetam effects on epilepsy

Phase 2
Conditions
Epilepsy.
Generalized idiopathic epilepsy and epileptic syndromes
Registration Number
IRCT2014083018973N1
Lead Sponsor
Deputy for research affairs of Shahrekord University of Medical Scince
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
20
Inclusion Criteria

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.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod
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.
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