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Compare valproate Sodium and Levetiracetam effects on epilepsy

Effect of Levetiracetam mono therapy in comparison with Sodium Valproate on juvenile myoclonic epilepsy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014083018973N1
Enrollment
20
Registered
2015-09-26
Start date
2014-06-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy. Generalized idiopathic epilepsy and epileptic syndromes

Interventions

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: T
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.

Sponsors

Deputy for research affairs of Shahrekord University of Medical Scince
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 25 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Jafar Mehvari

Isfahan University of Medical Scince

Jafarmehvari@med.mui.ac.ir+98 31 3777 2833

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026