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IRCT2013120115616N1 IRCT 2014-02-11 Tehran University of Medical Sciences Effect of memantine on migraine pelacebo controlled trial to double blind randomised evaluate memantine efficacy in Migraine without aura patients referred to Imam Khomeini hospital 2014-02-20 anticipated 60 Complete https://irct.ir/trial/14833 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 Migraine without aura. Intervention 1: After obtaining informed consent and explaining the possible side effects of medication, patients who have inclusion criteria will be randomized using Randomized Permuted Block and will be divided in two groups. the first group will be treated with Memantine (10 mg daily). Three month after the treatment, patients will be followed up. All patients will receive acute pain treatment. Intervention 2: In the second group, paitients who have inclusion criteria will be treated with placebo at a daily manner. Three month after the treatment, patients will be followed up. All patients will receive acute pain treatment.
public Leila Farsi
Brain and spinal cord injury research center-Reyhaneh building-Imam Khomeini hospital-Keshavarz boulevard-Tehran- Iran
Tehran Iran (Islamic Republic of) 1456833581 +98 21 6658 1560 lfarsi@razi.tums.ac.ir; lfarsi@gmail.com Brain and Spinal Cord Injury Rresearch Center- Tehran University of Medical Sciences scientific Abbas Tafakhori
Imam khomeini hospital-Tehran-Iran
Tehran Iran (Islamic Republic of) +98 21 6119 2424 abbas.tafakhori@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: patients suffering from migrane, according to the diagnostic criteria IHS1, with 2 attacks or more per month, that between their attacks experienced at least 48 hours without headache time, and had never received the drug for migraine prophylaxis for the past 3 months. Exclusion criteria: renal dysfunction; medication overuse headaches according to ICHD-II criteria; use of antipsychotics or antidepressants during the last 3 months; alcohol or drug abuse; allergy to Memantine and its compounds; treatment-resistant acute migraine; pain disorder; severe psychiatric illness; severe infection; malignancy; low survival chance; severe cardiovascular disease; neurodegenerative disorders; pregnancy and lactation; sexually active women of childbearing age that do not use any method of contraception 18 years 65 years Both G43.0 Migraine without aura [common migraine] Treatment - Drugs Placebo After obtaining informed consent and explaining the possible side effects of medication, patients who have inclusion criteria will be randomized using Randomized Permuted Block and will be divided in two groups. the first group will be treated with Memantine (10 mg daily). Three month after the treatment, patients will be followed up. All patients will receive acute pain treatment. In the second group, paitients who have inclusion criteria will be treated with placebo at a daily manner. Three month after the treatment, patients will be followed up. All patients will receive acute pain treatment. The mean number of migraine attacks per month (there must be at least a 48-hour interval between two attacks). Attacks occurred after waking up, or returned in 48 h after anti-migraine drug usage will not be considered separately. Timepoint: Change from baseline at three months in monthly attack frequency. Method of measurement: Use of migraine diary. The average number of the days with migraine per month. Timepoint: At the beginning and the end of study. Method of measurement: The average number of the days with migraine per month. Number of responders. Timepoint: Months 0,3. Method of measurement: 50% or greater reduction in frequency of attacks, 50% or greater reduction in the number of days with migraine. The type and number of medications used per attack. Timepoint: Months 0, 3. Method of measurement: Questionary. Depression. Timepoint: Months 0, 3. Method of measurement: Hospital anxiety and depression scale. Anxiety. Timepoint: Months 0, 3. Method of measurement: Hospital anxiety and depression scale. Sleep quality. Timepoint: Months 0, 3. Method of measurement: Pittsburgh sleep quality index. The average of pain score in 0-3 days before taking analgesic. Timepoint: Months 0, 3. Method of measurement: Questionary. Side Effects. Timepoint: Months 1, 2 and 3. Method of measurement: Severity (mild, moderate, severe) or being dangerous or non-dangerous. Functional disability. Timepoint: Months 0, 3. Method of measurement: Migraine Disability Assessment (MIDAS). Quality of life. Timepoint: Months 0, 3. Method of measurement: SF-12. Tehran University of Medical Sciences Approved 2013-09-22 Ethics committee of Tehran university of medical sciences Qods Avenu, Tehran University of Medical Sciences Tehran Iran (Islamic Republic of)