This study is a single blind clinical trial that will be performed in Isfahan city. The study population consists of all patients who Juvenile Myoclonic Epilepsy (JME) has been diagnosed in them for the first time and referred to the epilepsy clinic of Kashani hospital in Isfahan. The sample size is 20 samples collected using simple random sampling. Before start of Levotiracetam (LEV), informed consent from all patients will be taken. The 20 patients will randomly divide into two groups of 10, the LEV group and the Valproate sodium group. The course of treatment will be 6 to 12 months after initial the treatment. The first follow-up of patients will be after two weeks and then will be on a monthly basis. In every visit the doctor asks the number and type of seizures and the side effects of the drugs. Also examinations and assessments, EEG, vital signs and weight will be recorded. The inclusion criteria includes patients with JME and the exclusion criteria includes every diseases that its treatment in-tract with Valproate sodium and LEV. To ensure patient safety, before entering the study and every three months, liver enzymes, blood urea, creatinine and CBC of the patients will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014083018973N1
Registration date:2015-09-26, 1394/07/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-26, 1394/07/04
Registrant information
Name
Morteza Yousefi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3777 2833
Email address
yosefi.m@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2014-06-21, 1393/03/31
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Levetiracetam mono therapy in comparison with Sodium Valproate on juvenile myoclonic epilepsy
Public title
Compare valproate Sodium and Levetiracetam effects on epilepsy
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 8 years old to 25 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Science
Street address
Headquarter of Shahrekord University of Medical Scince, Kashani Avn, Shah re-kord, Iran
City
Shahrekord
Postal code
8174798866
Approval date
2014-05-23, 1393/03/02
Ethics committee reference number
93-3-2
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40.3
ICD-10 code description
Generalized idiopathic epilepsy and epileptic syndromes
Primary outcomes
1
Description
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
2
Description
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
3
Description
Count of myoclonus after treatment
Timepoint
3 and 6 mounths after initial treatment
Method of measurement
According to patients and thier fellows history
Secondary outcomes
1
Description
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
2
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.