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IRCT20250517065765N1 IRCT 2025-07-20 Vice-Chancellor for Research, Isfahan University of Medical Sciences A study on the effects of melatonin and amitriptyline on the severity and frequency of migraine headaches in children A Comparative Study on the Efficacy of Amitriptyline and Melatonin in the Preventive Treatment of Migraine in Children referred to Imam Hossain Hospital in 20205 2025-05-13 anticipated 60 Complete https://irct.ir/trial/83875 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be used, with 14 blocks of 4 participants each. The randomization process will be performed by a researcher not involved in the clinical management of participants. Both participants and the nurse administering the medication will be aware of group assignment, but the data analyst will remain blinded. Medications will be pre-coded, packed, and labeled prior to the study. At the time of assignment, the nurse will provide the medication package to the pediatric neurologist, who will calculate the appropriate dosage based on the child’s weight. Outcome assessment will be performed by a research assistant who is blinded to group allocation, Blinding description: In this study, only the outcome assessor and the data analyst are blinded. Medications are pre-coded and packed by an independent individual before the study begins. Clinical assessments are performed by a research assistant who is unaware of the treatment allocation. Data will also be provided to the statistician without group identifiers to ensure blinded statistical analysis. 3 Recurrent migraine headaches in children aged 5 to 15 years. Intervention 1: Group 1: Oral melatonin at a dose of 0.3 mg/kg (maximum 6 mg) once daily before bedtime for 90 days. Intervention 2: Intervention group: Oral amitriptyline at a dose of 1 mg/kg (maximum 50 mg) once daily before bedtime for 90 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the sensitive nature of the collected data, ethical considerations, and strict adherence to participant privacy and confidentiality, as advised by the Ethics Committee, individual participant data (IPD) will not be shared.
public Neda Hoseini Meshkenani
Imam Hossein Hospital – Pediatric Subspecialty Center, Imam Khomeini Expressway, Aminabad District, Isfahan, Iran
Isfehan Iran (Islamic Republic of) 81951-63381 +98 31 3386 6266 Nedahoseini8892@gmail.com Esfahan University of Medical Sciences scientific Neda Hoseini Meshkenani
Imam Hossein Hospital – Pediatric Subspecialty Center, Imam Khomeini Expressway, Aminabad District, Isfahan, Iran
Isfehan Iran (Islamic Republic of) 81951-63381 +98 31 3386 6266 Nedahoseini8892@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 1.Age between 5 and 15 years 2.Diagnosis of migraine headache (with or without aura) based on the second edition of the International Classification of Headache Disorders (ICHD-II), confirmed by a pediatric neurologist 3.Experiencing at least one headache episode per week 4.Having moderate to severe migraine-related disability, defined as a PedMIDAS score >10 5.No use of any migraine prophylactic medications prior to enrollment in the study 5 years 15 years Both 1.Children with secondary headaches or systemic diseases (e.g., renal or hepatic failure, cardiac, hematologic, or endocrine disorders), based on physical examination and paraclinical findings (e.g., lab tests or neuroimaging if increased intracranial pressure is suspected) 2.Children or parents unwilling to participate in the study 3.Children with a history of drug allergy 4.Children with epilepsy or complex migraine 5.Children showing severe and uncontrolled adverse effects to melatonin or amitriptyline 6.Children receiving other migraine prophylactic drugs (except melatonin or amitriptyline) 7.Children with migraine and significant psychiatric comorbidities (e.g., depression or ADHD) who use analgesics more than 4 times per week G43.0, G43 Migraine without aura [common migraine] ,Migraine with aura [classical migraine] Treatment - Drugs Treatment - Drugs Group 1: Oral melatonin at a dose of 0.3 mg/kg (maximum 6 mg) once daily before bedtime for 90 days Intervention group: Oral amitriptyline at a dose of 1 mg/kg (maximum 50 mg) once daily before bedtime for 90 days Number of migraine attacks per month before and after the intervention. Timepoint: Outcome variables will be measured at baseline (before intervention) and then every two weeks during the 3-month treatment period. Method of measurement: The number of migraine attacks will be recorded daily by the parents and children in a headache diary. Additionally, headache intensity will be assessed using the Numerical Rating Scale (NRS), and headache-related disability will be evaluated by the Pediatric Migraine Disability Assessment Scale (PedMIDAS) during biweekly visits. All data will be collected and recorded by a trained research assistant. Headache Frequency. Timepoint: Every 2 weeks during the 3-month treatment period. Method of measurement: Number of headache attacks recorded daily by parents and child in a headache diary. Headache Severity. Timepoint: Every 2 weeks at each visit. Method of measurement: Headache severity assessed using Numeric Rating Scale (NRS) or Visual Analog Scale (VAS). Headache Disability (pedMIDAS). Timepoint: At baseline and at the end of the 3-month treatment period. Method of measurement: Disability assessed by the Pediatric Migraine Disability Assessment Score (pedMIDAS) questionnaire. Analgesic Use. Timepoint: Throughout the treatment period. Method of measurement: Number of days the child used analgesics recorded in the diary. Drug Side Effects. Timepoint: Every 2 weeks at each visit. Method of measurement: Side effects recorded through parent reports and clinical examinations. Treatment Response. Timepoint: At the end of the 3-month treatment period. Method of measurement: More than 50% reduction in monthly headache frequency considered as good response. Part of the study expenses are funded by Isfahan University of Medical Sciences (Vice Chancellor for Research). The remaining expenses are self-funded. Approved 2025-05-12 Research Ethics Committee of Isfahan University of Medical Sciences No. 2, Sahar Alley, Western Omid Street, Mahfarrokhi Square, Khaneh Isfahan, Isfahan, Iran Isfehan Isfehan Iran (Islamic Republic of)