Protocol summary
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Study aim
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We aim to investigate the efficacy and safety of cinnarizine and sodium valproate in pediatric migraine prevention and comparing to placebo
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Design
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Pragmatic, community based, parallel group, double blind, randomised controlled trial
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Settings and conduct
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Prospective clinical trial in Childrens’ Medical Center, Tehran University f Medical Sciences, Tehran, Iran. All investigators, patients, and their parents are masked during the study.
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Participants/Inclusion and exclusion criteria
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Patients aged 6 to 17 years old with migraine (with or without aura), diagnosed according to the IHS criteria can be included. They have to have four or more migraine attack per 4 weeks; or sever dysfunction in daily activity. Headaches must not relate to any known structural brain lesion or other systemic conditions. Patients with chronic headache, complications of migraine or other migraine variants will be excluded. Focal neurologic deficit, history of diagnosed sensitivity to cinnarizine and sodium valproate, as well as pregnancy are other exclusion criteria. Patients who took prophylactic therapy for migraine within 8 weeks before study could not include into the study.
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Intervention groups
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Three arms in the study are 1) individuals receiving cinnarizine; 2) patients who will be under treatment with sodium valproate; and 3) participants getting placebo
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Main outcome variables
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Headache frequency; Headache intensity; More than 50% responder rate; Adverse effects
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201206306907N4
Registration date:
2012-09-15, 1391/06/25
Registration timing:
prospective
Last update:
2019-03-21, 1398/01/01
Update count:
1
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Registration date
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2012-09-15, 1391/06/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Tehran University of Medical Sciences
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Expected recruitment start date
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2009-10-23, 1388/08/01
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Expected recruitment end date
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2011-12-27, 1390/10/06
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Actual recruitment start date
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2015-02-18, 1393/11/29
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Actual recruitment end date
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2017-11-17, 1396/08/26
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Trial completion date
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2018-03-11, 1396/12/20
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Scientific title
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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
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Public title
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Cinnarizine and sodium valproate in prophylaxis of pediatric migraine .
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
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.
Exclusion criteria:
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
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Age
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From 6 years old to 17 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
Actual sample size reached:
109
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2009-09-23, 1388/07/01
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Ethics committee reference number
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35461
Health conditions studied
1
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Description of health condition studied
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Migraine
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ICD-10 code
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G43
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ICD-10 code description
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Migraine
Primary outcomes
1
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Description
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frequency of headache
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Timepoint
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frequency of frequency of each attack in a month
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Method of measurement
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questionnaire
2
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Description
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intensity of headache
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Timepoint
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intensity of each attack
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Method of measurement
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Visual analogue scale (VAS)
Secondary outcomes
1
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Description
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adverse effects
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Timepoint
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in the double-blind phase of the study
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Method of measurement
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ask from participants and parents
2
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Description
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More than 50% responder rate
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Timepoint
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in the double-blind phase of the study and baseline
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Method of measurement
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ask from participants and parents
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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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.
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Category
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Prevention
3
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Description
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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.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All collected data about primary and secondary outcomes
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When the data will become available and for how long
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After publication of paper
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To whom data/document is available
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To people working in academic institutions
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Under which criteria data/document could be used
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Data can be used if the authors’ names were mentioned
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From where data/document is obtainable
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Email
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What processes are involved for a request to access data/document
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After receiving the request we will consult to all authors and the data can be share in a week
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Comments
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