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IRCT20090412001808N5 IRCT 2018-03-22 Mazandaran University of Medical Sciences effects of propranolol and levetiracetam to prevent migraine attacks in children 5-15 year-old children Clinical trial of comparison of the effects of propranolol and levetiracetam to prevent migraine attacks in 5-15 year-old children 2018-03-20 anticipated 60 Complete https://irct.ir/trial/29056 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomized method is simple and by using random numbers' table. N/A Migraine. Intervention 1: Intervention group: In the intervention group, the Levetirastam tablet with brand name of Levebel made by Koobl Daroo Co. at a daily dose of 20 mg/kg is prescribed for 3 months. Intervention 2: Control group: In control group, 0.5-1 mg/kg Propranol tablet made by Koobl Daroo Co. is prescribed in two divided doses for 3 months. Yes - There is a plan to make this available What will be shared: Part of the data is available When: starting in January 2025 To whom: All people Conditions: Nothing Where to obtain: Please call Shiva Shadani: +98 912 596 4629 Email:shiva_shadani@yahoo.com How to obtain: After a call, information is sent within a few days Comments:
public Shiva Shadani
Bouali hospital, Pasdaran blvd., Sari, Iran
Sari Iran (Islamic Republic of) 38477-48158 +98 11 3334 2334 shiva_shadani@yahoo.com Mazandaran University of Medical Sciences scientific Ali Abbaskhanian
Bouali hospital, Pasdaran blvd., Sari, Iran
Sari Iran (Islamic Republic of) 38477-48158 +98 11 3334 2334 aabbaskhanian@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age 5 to 15 years migraine attacks headache more than once a week Headache causing a child's disability (PedMIDAS score more than 20) Headache prophylaxis is required in the child 5 years 15 years Both Underlying diseases such as asthma, liver disease, diabetes Secondary headaches or other neurological disorders such as epilepsy receiving medications for migraine over the past two months History of sensitivity to propranolol and levetiracetam history of propranolol and levetiracetam for migraine prophylaxis renal dysfunction G43 Migraine Prevention Prevention Intervention group: In the intervention group, the Levetirastam tablet with brand name of Levebel made by Koobl Daroo Co. at a daily dose of 20 mg/kg is prescribed for 3 months. Control group: In control group, 0.5-1 mg/kg Propranol tablet made by Koobl Daroo Co. is prescribed in two divided doses for 3 months Headache severity. Timepoint: The beginning of the study, the 3rd month and the 6th month. Method of measurement: Visual Analogue Scales (From a score of 1-10 that is scored by the child). Headache duration. Timepoint: The beginning of the study, the 3rd month and the 6th month. Method of measurement: minute. Number of migraine attacks per month. Timepoint: The beginning of the study, the 3rd month and the 6th month. Method of measurement: Number in the questionnaire. Side effects of medication (Dizziness, drowsiness, weight loss, anorexia, memory impairment, imbalance, skin complications). Timepoint: The 3rd month and 6th month. Method of measurement: Questionnaire. Severity of disability due to headache. Timepoint: The beginning of the study, the 3rd month and the 6th month. Method of measurement: Questionnaire (Grade 1: Score 0-10, Grade 2: Score 11-30, Grade 3: Score 31-50 and Grade 4: Scores above 50). Mazandaran University of Medical Sciences Approved 2017-08-07 Ethics committee of Mazandaran University of Medical Sciences Deputy of Science and Technology of Mazandaran University of Medical Sciences, Moallem square, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)