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IRCT20210925052579N1 IRCT 2022-03-18 Esfahan University of Medical Sciences Lacosamide and levetiracetam in partial epilepsy Evaluation and comparison of the effect of lacosamide with levetiracetam for control of resistant partial onset epilepsy 2022-03-19 anticipated 60 Complete https://irct.ir/trial/60040 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Information of all patients was given to random allocation software. The software categorized the patients into two groups by simple randomization method individually and in such a way that the mean age in the two groups was almost the same (with a difference of less than one standard deviation). 3 drug Resistant partial epilepsy. Intervention 1: The first intervention group is resistant partial onset epilepsy receiving lacosamide . Lacosamide is started orally at a dose of 50 mg twice daily and is increased to 300 mg daily depending on the patient's response and tolerance.Lacosamide is used under the brand name LACSA made by ACTOVERCO company and patients are treated with lacosamide for 3 months. Intervention 2: The second intervention group is resistant partial onset epilepsy receiving levetiracetam. Levetiracetam is started at a dose of 500 mg twice daily orally and can be increased to 3000 mg daily. Levetiracetam is used with the Levebel brand made by COBELDAROU company. Patients receive levetiracetam for three months. Yes - There is a plan to make this available What will be shared: Data on the main outcome of resistant partial onset epilepsy with lacosamide and levetiracetam can be generally shared. When: Six months after publishing the results. To whom: Everyone has access Conditions: Available for systematic review and meta-analysis. Where to obtain: First Author and author colleagues.(Via email) How to obtain: By email to the first author of the article and colleagues Comments:
public Dr. Maryam Sadat Hosseini Darenjani
No 360, Alley 3/6, Bagh hose Blvd
Shiraz Iran (Islamic Republic of) 7175967489 +98 71 4459 9283 dr.maryam.hosseini9896@gmail.com Esfahan University of Medical Sciences scientific Dr. Mohammad Reza Najafi
Al-Zahra Hospital, Sofe Blvd
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 najafi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with resistant partial onset epilepsy written informed consent age more than 18 years 18 years no limit Both cardiac arrhythmias for lacosamide group pregnancy for lacosamide group renal failure for levetiracetam group mood disorders for levetiracetam group G40.01 Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable Treatment - Drugs Treatment - Drugs The first intervention group is resistant partial onset epilepsy receiving lacosamide . Lacosamide is started orally at a dose of 50 mg twice daily and is increased to 300 mg daily depending on the patient's response and tolerance.Lacosamide is used under the brand name LACSA made by ACTOVERCO company and patients are treated with lacosamide for 3 months. The second intervention group is resistant partial onset epilepsy receiving levetiracetam. Levetiracetam is started at a dose of 500 mg twice daily orally and can be increased to 3000 mg daily. Levetiracetam is used with the Levebel brand made by COBELDAROU company. Patients receive levetiracetam for three months. Frequency of seizures in resistant partial onset epilepsy. Timepoint: Three months before the intervention, 1, 2 and 3 months after taking the drug. Method of measurement: questionnaire. Abnormal changes in the electroencephalogram. Timepoint: before the intervention and 3 months after taking drugs. Method of measurement: taking electroencephalogram. Drug side effects after taking lacosamide and levetiracetam. Timepoint: Within three months after starting the drug. Method of measurement: questionnaire. Esfahan University of Medical Sciences Approved 2021-08-01 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences and Health Services, Hezar Jerib St Isfahan Isfehan Iran (Islamic Republic of)