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IRCT20171212037850N1 IRCT 2018-05-01 Esfahan University of Medical Sciences Levetiracetam in migraine headaches of children A comparative study on the efficacy of levetiracetam and amitriptyline in childhood migraine; An open-label randomized controlled trial 2018-02-04 anticipated 60 Complete https://irct.ir/trial/29200 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the patients were selected for inclusion in the study, they would be randomly divided into two groups A and B, in the form of quadruple blocks using the Block Balanced Randomization Method. Neither researchers nor patients will know which patients will belong to which group and when administering the medicine, patients will be assigned to one of the groups A or B (Levetiracetam or Amitriptyline) on the basis of the block list. 3 Migraine. Intervention 1: Intervention group:Levetiracetam with a starting dose of 10 mg / kg given at a dose of 20 mg / kg in a week. In children and adults, the maximum dose is 3000 mg per day before bedtime, given for three months. Intervention 2: Control group: Amitriptyline is given at a dose of 5 to 12 mg / day and increases to 0.25 mg / kg / day for 2 weeks to reach the required dose of 1 mg / kg / day. The drug is given as a single dose at night. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Gholamreza Jelodar
No.102, Mikhak Ave., South Banafshe, Khane Isfahan
Isfahan Iran (Islamic Republic of) 8194834476 +98 31 3421 8176 jelodar-g@ajums.ac.ir Esfahan University of Medical Sciences scientific Gholamreza Jelodar
No.102, Mikhak Ave., South Banafshe, Khane Isfahan
Isfahan Iran (Islamic Republic of) 8194834476 +98 31 3421 8176 jelodar-g@ajums.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) All of children with migraine headache with or without aura, at least two attack per week or four attack per month, so that the attacks cause them to consume the analgesics or interfere with everyday activities 5 years 15 years Both Epilepsy Complicated migraine Not having the ability to record data related to the number, duration, and severity of headaches Use of other prophylactic drugs other than Levetiracetam and Amitriptyline Severe psychiatric problems like depression and ADHD Hypersensitivity to tricyclic anti depressants drugs Taking analgesic more than 4 times a week for migraine headache G43 Migraine Treatment - Drugs Treatment - Drugs Intervention group:Levetiracetam with a starting dose of 10 mg / kg given at a dose of 20 mg / kg in a week. In children and adults, the maximum dose is 3000 mg per day before bedtime, given for three months. Control group: Amitriptyline is given at a dose of 5 to 12 mg / day and increases to 0.25 mg / kg / day for 2 weeks to reach the required dose of 1 mg / kg / day. The drug is given as a single dose at night. Duration of headache. Timepoint: Before, one month later, two months later and three months after treatment began. Method of measurement: Daily Headache Registration Form. Headache severity. Timepoint: Before, one month later, two months later and three months after treatment began. Method of measurement: Wong-Baker FACES Pain Rating Scale. Headache frequency. Timepoint: Before, one month later, two months later and three months after treatment began. Method of measurement: Record daily diary of headache. Improving the quality of life. Timepoint: Before, one month later, two months later and three months after treatment began. Method of measurement: PedMIDAS quality of life checklist. Esfahan University of Medical Sciences Approved 2018-01-31 Ethics committee of Isfahan University of Medical Sciences Imam Hossein Children's Medical Education Center, Imam Khomeini Blvd. Daneshgah Square Isfahan Isfehan Iran (Islamic Republic of)