Headaches are common in children and migraine is the most frequent type of recurrent headache; to avoid analgesic overuse and to help the child resume normal activity, preventive pharmacological treatment should be administered. This study is double blind clinical trial. Patients of study: children who have diagnostic criteria for pediatric migraine; children who meet inclusion criteria assigned randomly into two groups. The frequency and intensity of headaches evaluated and documented before starting treatment. First group give Cinnarizine and other group receive placebo. This phase lasted 12 weeks and the response to medications were evaluated and documented monthly.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107216907N2
Registration date:2013-01-15, 1391/10/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-15, 1391/10/26
Registrant information
Name
Mahmoudreza Ashrafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6612 9252
Email address
ashrafim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Univercity of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cinnarizine versus placebo in pediatric migraine prophylaxis
Public title
Efficasy of cinnarizine in the prophylaxis of migraine headache
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Patients with migraine (with or without aura), diagnosed according to the International Headache society criteria. 2. Patients who had one or more migraine attack per week ; or sever dysfunction in daily and school activities during prospective baseline phase. 3. Headaches must not relate to any known structural brain lesion or other systemic conditions. Exclusion criteria: 1. Chronic headache, complications of migraine or other migraine variant. 2. Children and adolescents with Focal neurologic deficit. 3. History of diagnosed sensitivity to cinnarizine . 4. Patients who showed sever adverse effect to the study treatment drugs (in the double-blind phase of the study). 5. Serious comorbidities (hepatic, renal, cardiovascular or thyroid disease). 6. Patients who took prophylactic therapy for migraine within 4 weeks before study.
Age
From 5 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Keshavarz blv., Ghods avenue, ethic commitee of tehran university of medical science
City
Tehran
Postal code
Approval date
2012-07-18, 1391/04/28
Ethics committee reference number
91-02-54-18168
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
G43
ICD-10 code description
migraine
Primary outcomes
1
Description
frequency of headache
Timepoint
monthly
Method of measurement
questionnaire
2
Description
severity of headache
Timepoint
monthly
Method of measurement
questionnaire( VAS)
3
Description
duration of attack
Timepoint
monthly
Method of measurement
questionnaire
Secondary outcomes
1
Description
adverse effects of cinnarizine
Timepoint
each time during the study
Method of measurement
ask from participants and parents
Intervention groups
1
Description
cinnarizine tablet 0.6 - 1.5 mg/kg for patient weight under 30 kg and 50mg daily for patient greater than 30kg (3 months ) .
Category
Prevention
2
Description
placebo tablet 0.6 - 1.5 mg/kg for patient weight under 30kg and 50mg for patient greater than 30kg ,daily, (3 months )
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Children`s medical centre
Full name of responsible person
Dr. Mahmoodreza Ashrafi & Dr. Mansooreh Toghae
Street address
Children`s medical centre- dr gharib avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mrs. Rostamabadi
Street address
Poorsina avenue, Keshavarz blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Soodeh Salehi
Position
MD, resident of pediatrics
Other areas of specialty/work
Street address
Children`medical centre - Dr Gharib st.
City
Tehran
Postal code
1419733151
Phone
+98 21 6693 5848
Fax
Email
dr.salehi_79@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahmoodreza Ashrafi
Position
Proffesor of pediatric neurology
Other areas of specialty/work
Street address
Children`s medical centre
City
Tehran
Postal code
1419733151
Phone
+98 21 6693 5848
Fax
Email
mr_ashrafi@yahoo.comashrafim@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Soodeh Salehi
Position
MD, resident of pediatrics
Other areas of specialty/work
Street address
Children`s medical centre - Dr gharib
City
Tehran
Postal code
1419733151
Phone
+98 21 6693 5848
Fax
Email
dr.salehi_79@ yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)