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IRCT20211104052968N1 IRCT 2021-11-13 Esfahan University of Medical Sciences Effcacy of lacosomide on refractory focal seizures Effcacy of lacosomide on refractory focal seizures as add on therapy in children aged 6 months to 16 years 2020-12-30 anticipated 44 Complete https://irct.ir/trial/59827 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 seizure. Intervention group:. 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 Taybeh Mohammadi
Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 81 7467 3461 dr.t.mohammadi2020@gmail.com Esfahan University of Medical Sciences scientific Nasiri Jafar
Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 Nasiri.jafar@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) All children from 6 months to 16 years of age with focal seizures who have been diagnosed with at least one previous electroencephalogram and do not respond well to routine treatments despite appropriate treatment with at least two anticonvulsants within 8 weeks of enrollment. They have had at least two relapses in four weeks and have not been in complete control for three weeks, and have not changed their doses of other anticonvulsant drugs in the two weeks prior to enrollment. 6 months 16 years Both Previous administration of lacosamide as an anticonvulsant for at least two months prior to the examination renal deaseies Inability to tolerate the drug due to side effects Seizures caused by a progressive brain or neurodegenerative disease G40 ICD-10-CM Treatment - Drugs Intervention group: Reducing the severity and severity of seizures in children 6 months to 16 years according to the definition of refractory seizures in Nelson's book. Timepoint: Patients' seizures were monitored after the drug reached the therapeutic dose, which is six weeks, and then three months later. Method of measurement: The severity of seizures as a percentage and includes 8 categories 0 - 25, 25-50, 50 to 75 and 75 to 100% in the range of negative to positive 100% based on the initial rate of seizures. Esfahan University of Medical Sciences Approved 2021-01-25 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)