Although migraine is a common problem in children still no treatment has been approved for prevention of migraine in this group of patients.We designed this study to compare the efficacy and safety of cinarizine against sodium valproate in prevention of migraine headaches in patients under 18 years old.
70 participants aged between 6 to 17 years randomly divided in 2 treatment groups. Using visual analog scale, the frequency and intensity of headaches evaluated and documented before starting treatment and at 4,8and 12 weeks after treatment.in first group (n=35) we used cinnarizine ,37.5-50 mg daily; and in the second group(n=35) we used sodium valproate 10-20 mg daily.
Inclusion criteria:
Patients with migraine (with or without aura), diagnosed according to the IHS criteria ,had one or more migraine attack per month; or sever dysfunction in daily and Headaches must not relate to any known structural brain lesion or other systemic conditions.
Exclusion criteria:
Chronic headache, complications of migraine or other migraine variant,with Focal neurologic deficit,History of diagnosed sensitivity to each of drugs,Patients who showed sever adverse effect to the study treatment drugs,Serious comorbidities ,Patients who took prophylactic therapy for migraine within 4 weeks before study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206306907N4
Registration date:2012-09-15, 1391/06/25
Registration timing:retrospective
Last update:
Update count:1
Registration date
2012-09-15, 1391/06/25
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 University of Medical Sciences
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2011-09-01, 1390/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cinnarizine versus sodium valproate in prophylaxis of migraine among children and adolescents aged 6 to 17: a randomized, double-blind, clinical trial
Public title
Cinnarizine versus sodium valproate in prophylaxis of migraine .
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 month; 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 each of drugs that used in the study.
4. Patients whoshowed 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 6 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
tehran university of medical science
Street address
16 azar avenue,medical ethics comittee
City
tehran
Postal code
Approval date
2009-09-23, 1388/07/01
Ethics committee reference number
35461
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
frequency of frequency of each attack in a month
Method of measurement
questionnaire
2
Description
intensity of headache
Timepoint
intensity of each attack
Method of measurement
VAS, VPS
Secondary outcomes
1
Description
adverse effects of regime 1.
Timepoint
in the double-blind phase of the study
Method of measurement
ask from participants and parents
2
Description
adverse effects ofregime 2.
Timepoint
in the double-blind phase of the study
Method of measurement
ask from participants and parents
Intervention groups
1
Description
Our Randomized, double-blind, comparative trial had 2 phases: a prospective baseline phase (4 weeks) and a double-blind phase (12 weeks). Participants were 6-17 years old patients who attended in neurology clinic Of Children Medical Center Hospital of Tehran University of Medical Sciences and have fulfilled inclusion criteria.
At the first step of the study, all preventive or acute treatments for migraine stopped. Then using 90 day dairies, intensity and frequency of each attack were documented. In the second phase patients that completed baseline phase entered in the 12 weeks of double-blind study. We randomly (using a computer generated sequence six patient blocks) divided participants in 2 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. Both 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.
Category
Prevention
2
Description
Our Randomized, double-blind, comparative trial had 2 phases: a prospective baseline phase (4 weeks) and a double-blind phase (12 weeks). Participants were 6-17 years old patients who attended in neurology clinic Of Children Medical Center Hospital of Tehran University of Medical Sciences and have fulfilled inclusion criteria.
At the first step of the study, all preventive or acute treatments for migraine stopped. Then using 90 day dairies, intensity and frequency of each attack were documented. In the second phase patients that completed baseline phase entered in the 12 weeks of double-blind study. We randomly (using a computer generated sequence six patient blocks) divided participants in 2 groups: sodium valproate group received 10-20 mg/kg/day of sodium valproate. Both 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.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic Of Children Medical Center Hospital of Tehran University of Medical Sciences(markaz tebbi)
Full name of responsible person
Dr Mahmoodreza Ashrafi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Research Center of clinic Of Children Medical Center Hospital of Tehran University of Medical Scienc
Street address
Gharib avenue, Clinic Of Children Medical Center Hospital of Tehran University of Medical Sciences(markaz tebbi)
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
Mahtab Ramezani
Position
General practitioner
Other areas of specialty/work
Street address
Clinic Of Children Medical Center Hospital of Tehran University of Medical Sciences(markaz tebbi)
City
Tehran
Postal code
Phone
+98 21 6693 5848
Fax
Email
mahtab2918@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
Associate professor, Specialist in pediatrics neurologic disease
Other areas of specialty/work
Street address
Clinic Of Children Medical Center Hospital of Tehran University of Medical Sciences(markaz tebbi)
City
Tehran
Postal code
Phone
+98 21 6693 5848
Fax
Email
ashrafim@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)