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IRCT201206306907N4 IRCT 2012-09-15 Tehran University of Medical Sciences Cinnarizine and sodium valproate in prophylaxis of pediatric migraine . The efficacy and safety of cinnarizine and sodium valproate in prophylaxis of migraine among children and adolescents aged 6 to 17: a randomized, double-blind, placebo-controlled clinical trial 2009-10-23 anticipated 90 Complete https://irct.ir/trial/7340 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible outpatients were randomly assigned in a 1:1:1 ratio by permuted block randomization (block sizes of four) via an interactive web response system to receive either cinnarizine, sodium valproate or placebo, Blinding description: The study medications were coded and administered by a nurse of our medical center who was not informed about the clinical characteristics of cases. Investigators, participants, and their parents were masked during the course of the study until the code was broken at the end of the trial. Cinnarizine, sodium valproate, and placebo were provided as identical tablets in similar shapes and sizes in neutral containers. N/A Migraine. Intervention 1: We randomly divided participants in 3 groups: cinnarizine group received one Cinnarizine tablet (37.5 mg for patients aged 6 to 11 and 50 mg for others aged 12 to 17) per day. All drugs had a same color, package, and shape. Patients could use analgesics for abortive treatment of acute migraine attacks during the study.At 4th, 8th and 12th weeks of the second phase of the study, follow up visits were done. Participants' diaries were checked and with detailed questionnaires, any medicine-related side effects were investigated. Intervention 2: We randomly divided participants in 3 groups: sodium valproate group received 10-20 mg/kg/day of sodium valproate. All drugs had a same color, package, and shape. Patients could use analgesics for abortive treatment of acute migraine attacks during the study.At 4th, 8th and 12th weeks of the second phase of the study, follow up visits were done. Participants' diaries were checked and with detailed questionnaires, any medicine-related side effects were investigated. Intervention 3: Control group: We randomly divided participants in 3 groups: placebo group received tablets similar to cinnarizine and sodium valproate groups in color, package, and shape. Patients could use analgesics for abortive treatment of acute migraine attacks during the study.At 4th, 8th and 12th weeks of the second phase of the study, follow up visits were done. Participants' diaries were checked and with detailed questionnaires, any medicine-related side effects were investigated. Yes - There is a plan to make this available What will be shared: All collected data about primary and secondary outcomes When: After publication of paper To whom: To people working in academic institutions Conditions: Data can be used if the authors’ names were mentioned Where to obtain: Email How to obtain: After receiving the request we will consult to all authors and the data can be share in a week Comments:
public Mahtab Ramezani
Clinic Of Children Medical Center Hospital of Tehran University of Medical Sciences(markaz tebbi)
Tehran Iran (Islamic Republic of) 1417653761 +98 21 6693 5848 manoochehr_1993@yahoo.com Tehran University of Medical Sciences scientific Dr Mahmoodreza Ashrafi
Clinic Of Children Medical Center Hospital of Tehran University of Medical Sciences(markaz tebbi)
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6693 5848 ashrafim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with migraine (with or without aura), diagnosed according to the International Headache society criteria Patients who had at least four migraine attacks per 4 weeks; or sever dysfunction in daily and school activities during prospective baseline phase. 6 years 17 years Both Chronic headache, complications of migraine or other migraine variant Children and adolescents with Focal neurologic deficit History of diagnosed sensitivity to each of drugs that used in the study Patients who took prophylactic therapy for migraine within 8 weeks before study. Headaches related to structural brain lesions Pregnancy G43 Migraine Prevention Prevention Prevention We randomly divided participants in 3 groups: cinnarizine group received one Cinnarizine tablet (37.5 mg for patients aged 6 to 11 and 50 mg for others aged 12 to 17) per day. All drugs had a same color, package, and shape. Patients could use analgesics for abortive treatment of acute migraine attacks during the study.At 4th, 8th and 12th weeks of the second phase of the study, follow up visits were done. Participants' diaries were checked and with detailed questionnaires, any medicine-related side effects were investigated. We randomly divided participants in 3 groups: sodium valproate group received 10-20 mg/kg/day of sodium valproate. All drugs had a same color, package, and shape. Patients could use analgesics for abortive treatment of acute migraine attacks during the study.At 4th, 8th and 12th weeks of the second phase of the study, follow up visits were done. Participants' diaries were checked and with detailed questionnaires, any medicine-related side effects were investigated. Control group: We randomly divided participants in 3 groups: placebo group received tablets similar to cinnarizine and sodium valproate groups in color, package, and shape. Patients could use analgesics for abortive treatment of acute migraine attacks during the study.At 4th, 8th and 12th weeks of the second phase of the study, follow up visits were done. Participants' diaries were checked and with detailed questionnaires, any medicine-related side effects were investigated. Frequency of headache. Timepoint: frequency of frequency of each attack in a month. Method of measurement: questionnaire. Intensity of headache. Timepoint: intensity of each attack. Method of measurement: Visual analogue scale (VAS). Adverse effects. Timepoint: in the double-blind phase of the study. Method of measurement: ask from participants and parents. More than 50% responder rate. Timepoint: in the double-blind phase of the study and baseline. Method of measurement: ask from participants and parents. Tehran University of Medical Sciences Approved 2009-09-23 tehran university of medical science 16 azar avenue,medical ethics comittee tehran Tehran Iran (Islamic Republic of)