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IRCT20240930063218N1 IRCT 2024-12-19 Ghoum University of Medical Sciences Comparison of the clinical effect and side effects of lacosamide with topiramate in controlling migraine headaches Comparison of the clinical effect and side effects of lacosamide with topiramate in controlling migraine headaches during 3 months 2024-10-31 anticipated 60 Complete https://irct.ir/trial/79277 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: block Randomization Unit: Individual Randomization tool: questionnaire and software, Blinding description: Patients are treated with pre-determined drug packages by the study supervisor (supervisor). The drug packages are identical in appearance, and both the patient and the study implementer are unaware of the contents of the packages. Additionally, data collection, patient assessment, and form completion are carried out by the study implementer and their assistant, who are also unaware of the contents of the packages. In the data analysis phase, the analysis is conducted by the study supervisor and the study implementer, who are unaware of the contents of the drug packages, and only the patient groups (Group 1 or Group 2) are identified for data analysis. Therefore, the study is triple-blind, and from the moment the patient enters the study until the completion of the study, data collection, and information analysis, the contents of the two drug groups remain unknown. 3 Migraine. Intervention 1: Intervention group: This study is designed as a triple-blind randomized clinical trial. All patients meeting the inclusion criteria will be considered for participation in the study at the time of enrollment. After obtaining written informed consent and explaining the study conditions, patients will be asked to rate their pain level based on the VAS scale. They will then be randomly assigned to one of the study groups. The first group will receive topiramate (manufactured by Darou Pakhsh Company, Tehran, Iran), and the second group will receive lacosamide (manufactured by Caspian Darou Company, Rasht, Iran). It is important to note that patients receiving lacosamide will also be monitored with ECG.In the lacosamide group, patients will receive 100 mg of lacosamide twice daily in the first week, 150 mg every 12 hours in the second week, and 200 mg twice daily in the third week, if tolerated. In the topiramate group, patients will receive 25 mg of topiramate once daily in the first week, followed by 25 mg twice daily thereafter.Patients will be grouped based on the Balanced Randomization method into two groups, A and B. Both analgesic medications will be placed in boxes A and B, with only the responsible physician (the principal investigator) aware of the contents of each group. Each patient will then be assigned a number by the principal investigator, which will be recorded in a notebook. For example, patient number 1 will receive medication A, and patient number 2 will receive medication B, or vice versa, with the blinding method explained below.It is worth noting that both groups of patients will continue their routine migraine treatment, and routine treatment will not be discontinued. In the event of a headache, patients will be given analgesics to ensure they receive effective treatment, which will include various NSAIDs. Intervention 2: Intervention group: In the lacosamide group, patients will receive 100 mg of lacosamide twice daily in the first week, 150 mg every 12 hours in the second week, and 200 mg twice daily in the third week, if tolerated. In the topiramate group, patients will receive 25 mg of topiramate once daily in the first week, followed by 25 mg twice daily thereafter. Intervention 3: Control group: In the topiramate group, patients will receive 25 mg of topiramate once daily in the first week, followed by 25 mg twice daily thereafter. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information available.
public Research DepartmentResident
Shahid beheshti street
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 dr.mohammadjavadkhadem@gmail.com Ghoum University of Medical Sciences scientific Fereshteh
Shahid beheshti street
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 darkness.8090100@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Patients with migraine headache 18 years 50 years Both Under 18 years old Pregnant women Cardiovascular diseases G43 Migraine Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: This study is designed as a triple-blind randomized clinical trial. All patients meeting the inclusion criteria will be considered for participation in the study at the time of enrollment. After obtaining written informed consent and explaining the study conditions, patients will be asked to rate their pain level based on the VAS scale. They will then be randomly assigned to one of the study groups. The first group will receive topiramate (manufactured by Darou Pakhsh Company, Tehran, Iran), and the second group will receive lacosamide (manufactured by Caspian Darou Company, Rasht, Iran). It is important to note that patients receiving lacosamide will also be monitored with ECG.In the lacosamide group, patients will receive 100 mg of lacosamide twice daily in the first week, 150 mg every 12 hours in the second week, and 200 mg twice daily in the third week, if tolerated. In the topiramate group, patients will receive 25 mg of topiramate once daily in the first week, followed by 25 mg twice daily thereafter.Patients will be grouped based on the Balanced Randomization method into two groups, A and B. Both analgesic medications will be placed in boxes A and B, with only the responsible physician (the principal investigator) aware of the contents of each group. Each patient will then be assigned a number by the principal investigator, which will be recorded in a notebook. For example, patient number 1 will receive medication A, and patient number 2 will receive medication B, or vice versa, with the blinding method explained below.It is worth noting that both groups of patients will continue their routine migraine treatment, and routine treatment will not be discontinued. In the event of a headache, patients will be given analgesics to ensure they receive effective treatment, which will include various NSAIDs. Intervention group: In the lacosamide group, patients will receive 100 mg of lacosamide twice daily in the first week, 150 mg every 12 hours in the second week, and 200 mg twice daily in the third week, if tolerated. In the topiramate group, patients will receive 25 mg of topiramate once daily in the first week, followed by 25 mg twice daily thereafter Control group: In the topiramate group, patients will receive 25 mg of topiramate once daily in the first week, followed by 25 mg twice daily thereafter. Intensity and frequency of headaches. Timepoint: 3 months. Method of measurement: Visual analogue scale. Ghoum University of Medical Sciences Approved 2024-07-22 Ethics Committee of Qom University of Medical Sciences Shahid beheshti Qom Ghoum Iran (Islamic Republic of)