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IRCT20180624040229N1 IRCT 2019-01-02 Ardabil University of Medical Sciences Comparison the effects of memantine and sodium valproate in migraine pain prophylaxis Comparison the effects of memantine and sodium valproate in migraine pain prophylaxis 2018-01-21 anticipated 80 Complete https://irct.ir/trial/33140 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Blinding description: The way of participant blindness is that he will receive and use a certain number of drugs in an unnamed and labeled envelope. The way of physicians blindness is that after he has been diagnosed migraine to his patient and notice his secretary, randomly given one of the envelopes to the patient. The way of researcher's blindness is that he will not be present in the filling envelopes and selecting them. 3 Migraine. Intervention 1: First intervention group: Memantine, 5 mg oral tablet (Sobhan company), twice a day for 12 weeks. Then 4 weeks without taking any medication. Then take 200 mg of sodium valproate (Raha company), twice a day for 12 weeks. Intervention 2: Second Intervention group: Sodium valproate, 200 mg oral tablet (Raha company), twice a day for 12 weeks. Then 4 weeks without taking any medication. Then take 5 mg of Memantine (Sobhan company), twice a day for 12 weeks. Yes - There is a plan to make this available What will be shared: After unidentified people, demographic data and MIDAS score will be used to evaluate the headache. When: Starting the access from 2020 To whom: Access will be free for everyone Conditions: Statistical analyzes are allowed on data Where to obtain: Will be contact by Dr Abbasi`s email How to obtain: It takes a total of one month Comments: No other information is required
public Vahid Abbasi
No 1, Moallem St
Ardabil Iran (Islamic Republic of) 5613843793 +98 45 3323 0739 reseteam.2020@gmail.com Ardabil University of Medical Sciences scientific Vahid Abbasi
No. 1, Moallem St
Ardabil Iran (Islamic Republic of) 5613843739 +98 45 3323 0739 reseteam.2020@gmail.com Ardabil University of Medical Sciences Iran (Islamic Republic of) A history of migraines based on the criteria of the international community of headache. The number of headache attacks is more than three attacks per month. Failure of prophylactic treatment with one or more migraine prevention drugs. Any headache attack with more than 48 hours of analgesia should be distinguished from other attacks Filling out the consent form of the Clinical trial age 16 to 65 16 years 65 years Both Other headache Use of other migraine prevention medications Drug dependence on drugs or alcohol Renal dysfunction Excessive use of acute migraine attack drugs (more than 8 days in the month of receiving ergots, NSAIDs or tryptans) Sensitization to memantine or sodium valproate or their compounds. Acute resistant migraine Severe psychiatric disorders (bipolar disorder, mental disorder, severe depressive disorder, obsessive-compulsive disorder, or functional disorder, general anxiety disorder, Somatization) Neurodegenerative disorders malignancy , pain disorder, severe infection Pregnant or Breastfeeding women G43.0 Migraine without aura Treatment - Drugs Treatment - Drugs First intervention group: Memantine, 5 mg oral tablet (Sobhan company), twice a day for 12 weeks. Then 4 weeks without taking any medication. Then take 200 mg of sodium valproate (Raha company), twice a day for 12 weeks Second Intervention group: Sodium valproate, 200 mg oral tablet (Raha company), twice a day for 12 weeks. Then 4 weeks without taking any medication. Then take 5 mg of Memantine (Sobhan company), twice a day for 12 weeks Headache score by MIDAS score. Timepoint: At the beginning , 3 month later, 6 month later. Method of measurement: MIDAS score. Ardabil University of Medical Sciences Approved 2017-10-23 Ethics committee of Ardabil University of Medical Sciences No. 1, Moallem street, Ardabil Ardabil Iran (Islamic Republic of)