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IRCT20250526065900N1 IRCT 2026-08-21 Islamic Azad University Comparison of the effects of Mirtazapine and Topiramate in treatment of Migrane Comparison of the effects of Mirtazapine and Topiramate on headache severity in patients with migraine 2026-08-21 anticipated 60 Complete https://irct.ir/trial/84033 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients, following the verification of inclusion and exclusion criteria and the procurement of informed consent, will be randomized in a 1:1 ratio into one of the two treatment groups: the mirtazapine group or the topiramate group. The unit of randomization will be the individual (patient), with each patient being assigned to only one of the two study groups. To generate the randomization sequence, a computer-based block randomization method with variable block sizes will be employed to minimize the predictability of subsequent allocations. This sequence will be generated using R statistical software by an independent researcher who is not involved in the patient recruitment or assessment process. In this process, the total required sample size will first be determined, followed by the generation of the allocation sequence in a 1:1 ratio, ensuring that within each block, the number of allocations to both groups is equal to maintain a balanced total number of patients in both groups as much as possible. No stratification will be applied in this study, and all eligible patients will be placed within a single randomization sequence. Following the generation of the randomization sequence by the independent researcher, a unique code will be assigned to each patient. Patients will be numbered according to their order of enrollment after eligibility is confirmed, and each patient will be assigned to one of the two treatment groups based on the randomization code corresponding to their number. To ensure allocation concealment and prevent bias by withholding treatment allocation information from the investigator responsible for recruitment, the randomization sequence will be generated and maintained by an independent individual outside of the recruitment and assessment process. Consequently, the investigator responsible for enrolling patients will remain unaware of whether a patient is assigned to the mirtazapine or topiramate group until all inclusion criteria have been fully met, informed consent has been obtained, and the patient is formally registered in the study. Once formal enrollment is complete, allocation will be performed based on the pre-determined sequence, thereby minimizing the possibility of intentional selection or group changes based on prior knowledge, Blinding description: This study is a randomized, single-blind clinical trial. The assessors will be blinded to the type of intervention (i.e., which medication is being administered). Drug coding and labeling will be performed by an independent individual or organization that is not involved in the implementation of the intervention or the assessment of outcomes. 3 Migraine. Intervention 1: Intervention group: Patients with migraine who will receive mirtazapine at a starting dose of 15 mg once daily, with a target dose of 30 mg once daily. Intervention 2: Control group: Patients with migraine who will receive mirtazapine at a starting dose of 25 mg once daily, with a target dose of 50 mg once daily. 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 further information is available
public Radnoush Pashmforoush
Administrative Building, Islamic Azad University of Medical Sciences, Corner of Gol Yakh Street and Abneh Boulevard, Pabarja Street, Gholhak Junction, Dr. Shariati Street
Tehran Iran (Islamic Republic of) 1949635881 +98 21 2261 8515 drp922@yahoo.com Islamic Azad University scientific Radnoush Pashmforoush
Administrative Building, Islamic Azad University of Medical Sciences, Corner of Gol Yakh Street and Abneh Boulevard, Pabarja Street, Gholhak Junction, Dr. Shariati Street
Tehran Iran (Islamic Republic of) 1949635881 +98 21 2261 8515 drp922@yahoo.com Islamic Azad University Iran (Islamic Republic of) Patients experiencing migraine for at least 4 days per month Patients who have undergone at least 2 previous unsuccessful migraine prophylaxis treatments Duration of migraine illness exceeding one year 18 years 70 years Both Presence of serious diseases other than migraine that might affect the study results Use of other medications that may affect the course of the migraine or the efficacy of the study medications. G43 Migraine Treatment - Drugs Treatment - Drugs Intervention group: Patients with migraine who will receive mirtazapine at a starting dose of 15 mg once daily, with a target dose of 30 mg once daily. Control group: Patients with migraine who will receive mirtazapine at a starting dose of 25 mg once daily, with a target dose of 50 mg once daily. Headache severity score based on MIDAS questionnaire. Timepoint: 4 and 8 weeks after medication use. Method of measurement: By the MIDAS questionare. Islamic Azad University Approved 2025-03-16 Ethics Committee of Tehran Azad University of Medical Sciences No. 62, Proshat Street, Shekarabi Street, Shariati Street, Sohrevardi Street Tehran Tehran Iran (Islamic Republic of)