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IRCT20191205045623N1 IRCT 2019-12-26 Ahvaz University of Medical Sciences Prophylactic Effect of Memantine on Chronic Migraine Headache The effectiveness of adding Memantine to Topiramate in the prevention of headache attacks among patients with chronic migraine headaches 2017-04-20 anticipated 54 Complete https://irct.ir/trial/44018 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization method was used for randomization. Nine blocks were created by www.randomizer.org. The blocks were the same size and equal to 6. In each block, there were three allocations for the intervention group and three allocations for the control one. In each block, 1 and 2 numbers were given in different order, which determined the group of patients. Number one was considered as intervention group and number two was used as control group. Patients were randomly assigned to intervention or control groups after diagnosis of chronic migraine on the basis of one and two numbers in blocks.Also the random sequence of blocks was in the hands of an individual other than the researcher who, by telephone, provided only the required number indicating the intervention or control group. Without researchers intervention, the patients were assigned to each groups based on numbers. After sampling accomplisehed, each groups had the same size with number of 27, Blinding description: None of the patients in this study knew that they were in the intervention or control group and that the treatment received was either drug or placebo. Also, none of the researchers had a direct role in the process of grouping and follow up of patients. 3 Migraine headache. Intervention 1: Intervention group: Patients in intervention group received Memantine tablet 20 mg daily which reached this level after 4 weeks and they received topiramate tablet 50 mg daily as a base medication which started at 25 mg daily and increased to 50 mg daily in two weeks. Intervention 2: Control group: Patients in control group received placebo that it was similar to memantine tablet in shape and color and they received topiramate tablet 50 mg daily as a base medication which started at 25 mg daily and increased to 50 mg daily in two weeks. 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 more information.
public Davood Kashipazha
Department of Neurology, Golestan Hospital, Farvardin St., Golestan
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3012 dakashi47@gmail.com Ahvaz University of Medical Sciences scientific Davood Kashipazha
Department of Neurology, Golestan Hospital, Farvardin St., Golestan
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3012 dakashi47@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 18 to 65 years old Chronic migraine headache according to International Classification of headache 18 years 65 years Both Pregnancy or breast-feeding Renal or hepatic impairment or known cardiovascular disease History of allergy to memantine and topiramate G43 Migraine Treatment - Drugs Placebo Intervention group: Patients in intervention group received Memantine tablet 20 mg daily which reached this level after 4 weeks and they received topiramate tablet 50 mg daily as a base medication which started at 25 mg daily and increased to 50 mg daily in two weeks. Control group: Patients in control group received placebo that it was similar to memantine tablet in shape and color and they received topiramate tablet 50 mg daily as a base medication which started at 25 mg daily and increased to 50 mg daily in two weeks. The severity of migraine headache attacks. Timepoint: This evaluation was performed at the beginning of the study, and the end of first, second, third and fourth months of the study. Method of measurement: Visual Analogue Scale. The disability level of migraine headache attacks. Timepoint: This evaluation was performed at the beginning of the study, and the end of first, second, third and fourth months of the study. Method of measurement: Migraine Disability Assessment Test Survey (MIDAS). The frequency of migraine headache attacks. Timepoint: This evaluation was performed at the beginning of the study, and the end of first, second, third and fourth months of the study. Method of measurement: Daily headache diary. The duration of migraine headache attacks. Timepoint: This evaluation was performed at the beginning of the study, and the end of first, second, third and fourth months of the study. Method of measurement: Daily headache diary. Ahvaz University of Medical Sciences Approved 2017-04-20 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Development Research and Technology, Ahwaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan Blvd, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)