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IRCT20190804044429N9 IRCT 2022-09-20 Mazandaran University of Medical Sciences The effects of lacosamide and toptramate combination therapy on chronic migraine The effects of lacosamide and topiramate versus topiramate and placebo combination therapy on headache in patients with chronic migraine: A randomized double-blind clinical trial 2022-09-23 anticipated 74 Complete https://irct.ir/trial/65371 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random block method will be used to allocate the samples to two groups. Blocks will be considered as blocks of size 4 and in each block of 4 people, two people in the intervention group and two people in the control group will be selected. The selection of the order type for each person in each group will be done through second version of random allocation software, Blinding description: This study is double_ blind. Medicines and placebo in the same color and size forms will be packed in medicine envelopes of the same shape and color and will be provided to the patients. Outcome elevator and participant are blinded (double blind) and aware from grouping (intervention or placebo). 3 Migraine Headache. Intervention 1: Intervention group: In the first week, all patients will receive lacosamide 100 mg twice a day, and from the second week, they will also receive 150 mg every 12 hours, and in the third week, 200 mg twice a day, if they tolerate, and they will also receive topiramate 25 mg once a day in the first week and after that 25 mg twice a day. Intervention 2: Control group: all patients will receive placebo with the same shape and color as lacosamide twice a day, and they will also receive topiramate 25 mg once a day in the first week and after that 25 mg twice a day. Yes - There is a plan to make this available What will be shared: Data related to the initial outcomes of the study will be shared When: The data will be available one year after publication To whom: Academic researchers, medical team and scientific institutes Conditions: Requests for sharing data should be sent to the person responsible for general inquiries Where to obtain: Requests for sharing data should be sent to the person responsible for general inquiries. ghazaeianm@gmail.com How to obtain: Person in charge of scientific study will reply to the request within 10 days. Comments:
public Monireh Ghazaeian
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran
Sari Iran (Islamic Republic of) 4815733971 +98 21 8863 6864 ghazaeianm@gmail.com Mazandaran University of Medical Sciences scientific Monireh Ghazaeian
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran.
Sari Iran (Islamic Republic of) 48157-33971 +98 11 3334 3010 ghazaeianm@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Adults over 18 years old migraine (with or without aura) moderate to high intensity migraine headache (VASā‰„4) 18 years no limit Both Severe depression or suicidal thoughts Thyroid disorders Pregnancy Lactation History of ischemic cerebral disease or ischemic heart disease Renal dysfunction (GFR less than 30 ml/min) medication overuse headache History of drug abuse and alcohol History of hepatic failure A history of cardiac arrhythmia or using drugs that affect heart rhythm G43 Migraine Treatment - Drugs Treatment - Drugs Intervention group: In the first week, all patients will receive lacosamide 100 mg twice a day, and from the second week, they will also receive 150 mg every 12 hours, and in the third week, 200 mg twice a day, if they tolerate, and they will also receive topiramate 25 mg once a day in the first week and after that 25 mg twice a day. Control group: all patients will receive placebo with the same shape and color as lacosamide twice a day, and they will also receive topiramate 25 mg once a day in the first week and after that 25 mg twice a day. The number of days that the individual has experienced headache. Timepoint: At the beginning of the study, in the 8th week (56 days after baseline) and in the 11th week (84 days after baseline). Method of measurement: History taking. The number of headache attacks. Timepoint: weekly, up to 12 weeks. Method of measurement: Visual analogue scale (VAS). Disability improvement. Timepoint: Baseline and third month. Method of measurement: Migraine Disability Assessment. Mazandaran University of Medical Sciences Approved 2022-08-08 Mazandaran University of Medical Sciences Ibn Sina Hospital, Pasdaran Blvd Sari Mazandaran Iran (Islamic Republic of)