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IRCT20250508065645N1 IRCT 2025-05-16 Tehran University of Medical Sciences Single-dose topiramate in migraine prophylaxis Comparison of the therapeutic effects of using single-dose and twice-daily topiramate for migraine prophylaxis in children aged 5 to 18 years referred to Tehran Children's Medical Center Hospital 2025-06-22 anticipated 70 Complete https://irct.ir/trial/83504 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study randomization was employed to randomly assign participants to treatment groups. This method aids in maintaining group balance and controlling confounding variables by dividing participants into homogeneous blocks and randomizing within each block. 3 Migraine. Intervention group: In the present study the calculated therapeutic dose of topiramate for pediatric patients was based on guidelines from the American Academy of Neurology (AAN) and the American Headache Society (AHS), which recommend a dose of 2 mg/kg/day with a maximum of 100 mg/day. Topiramate was initiated at a dose of 1 mg/kg/day for participants and, if necessary, titrated according to a predefined schedule to reach the optimal dose.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No decision has been made regarding the publication of the information in question. It will be reviewed after consultation with the respected professors, advisors, and supervisors.
public Sina Fathi
Koohestan St. , Farahzadi Blvd.
Tehran Iran (Islamic Republic of) 1981655715 +98 21 2238 1781 sina_fth74@yahoo.com Tehran University of Medical Sciences scientific Sina Fathi
Koohestan St. , Farahzadi Blvd.
Tehran Iran (Islamic Republic of) 1981655715 +98 21 2238 1781 sina_fth74@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) The inclusion criteria for the study are children aged 5 to 18 years diagnosed with migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) , candidates for prophylactic treatment who experienced a minimum of two migraine attacks per month , and obtained informed consent from their parents or legal guardians to participate in the study 5 years 18 years Both G43 Migraine Treatment - Drugs Intervention group: In the present study the calculated therapeutic dose of topiramate for pediatric patients was based on guidelines from the American Academy of Neurology (AAN) and the American Headache Society (AHS), which recommend a dose of 2 mg/kg/day with a maximum of 100 mg/day. Topiramate was initiated at a dose of 1 mg/kg/day for participants and, if necessary, titrated according to a predefined schedule to reach the optimal dose. Headache frequency, headache severity, headache duration, headache-related disability, side effects. Timepoint: At the beginning of the study, 3 months and 6 months after taking the medication. Method of measurement: History, Verbal Pain Scale, Visual Analogue Scale, Pediatric Migraine Disability Assessment (PedMIDAS). Tehran University of Medical Sciences Approved 2025-04-19 Ethics committee of Tehran University of Medical Sciences Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)