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IRCT20220524054982N1 IRCT 2022-11-06 Ghoum University of Medical Sciences Investigation of the effectiveness of lacosamide in generalized seizures. Comparative study of the clinical effect and side effects of lacosamide and sodium valproate in reducing and controlling seizures in generalized seizures during six months 2022-11-22 anticipated 120 Complete https://irct.ir/trial/66066 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be done (blocks 4 and 6). Proprietary sequences and secret codes are generated using www.sealedenvelope.com. 3 Generalized tonic-clonic seizures.. Intervention 1: In the intervention group, lacosamide is used orally and monotherapy at a dose of 200 mg twice a day (any brand). Patients are followed up for six months and checked for the number of seizures. Intervention 2: In the control group, the drug sodium valproate with a dose of 500 mg twice a day is used orally and monotherapy. Patients are followed up for six months and checked for the number of seizures. Yes - There is a plan to make this available What will be shared: In this study, statistical data (mean, minimum and maximum) of demographic variables of all samples and not individually studied can be published and the results of drug effectiveness after data analysis can be published without mentioning the names and details of individuals When: Start the access period after publishing the results To whom: All scientific and academic researchers with mentioning the name and scientific affiliation Conditions: Using the method of studying and analyzing data and results with the permission of the authors or scientific citations in journals, articles and sources is allowed. Where to obtain: To the corresponding author whose email details were given and also specified in the relevant articles How to obtain: The request will be sent by email. After consulting with the other authors and agreeing to sponsor the project, the information that can be published will be made available to another person or organization Comments:
public Seyyed Amir Hejazi
Qom, Shahid Beheshti Boulevard, Azadegan Square, Shahid Beheshti Hospital
QOM Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 assh.hejazi@gmail.com Ghoum University of Medical Sciences scientific Payam Molavi
Qom, Shahid Beheshti Boulevard, Azadegan Square, Shahid Beheshti Hospital
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 Molavi.payam@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Having generalized tonic-clonic seizures Over eighteen years of age Consent to participate in the study Not taking multiple anticonvulsants at the same time 18 years 85 years Both Willingness of patients to withdraw from the study - Having a chronic disease that interferes with the evaluation of the patient Having heart diseases pregnancy G40 Epilepsy and recurrent seizures Treatment - Drugs Treatment - Drugs In the intervention group, lacosamide is used orally and monotherapy at a dose of 200 mg twice a day (any brand). Patients are followed up for six months and checked for the number of seizures. In the control group, the drug sodium valproate with a dose of 500 mg twice a day is used orally and monotherapy. Patients are followed up for six months and checked for the number of seizures. Tonic-clonic seizure. Timepoint: On the first day and three months later and six months after starting the drug. Method of measurement: EEG device and patient bedside. Ghoum University of Medical Sciences Approved 2022-03-06 Qom University of Medical Sciences and Health Services Qom Province, Qom, Shahid Lavasani St, MV2R+P89 Qom Ghoum Iran (Islamic Republic of)