Migraine is the most important and frequent type of headache in children. Prophylactic therapy should be considered if a child experiences more than two to four severe episodes monthly or is unable to attend school regularly. The purpose of this study is to compare efficacy and safety of propranolol and topiramate in prophylaxis of migraine headache in children. In this study , eighty 5-15 year old children with migraine headache whom were referred to pediatric neurology clinic of Shahid Sadoughi University of Medical Sciences and prophylactic therapy indicated in them , are evaluated .
The children are distributed into two groups. In both groups, oral drug and in two divided doses will be prescribed. In one group , 5mg/kg/day of topiramate and in other one , 1mg/kg/day of propranolol will be given . Number , severity and disability score of migraine headache and side effects of drugs are to be compared before and three months after treatment .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111282639N6
Registration date:2011-12-05, 1390/09/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-05, 1390/09/14
Registrant information
Name
Razieh Fallah
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
fallah@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of topiramate and propranolol in prophylaxis of migraine headache in children
Public title
Topiramate and propranolol in migraine of children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. children aged 5-15 years
2. Having migraine headache based on International Headache Society Criteria
3. Having also at least two episode of migraine headache in one month
4. No previous prophylactic therapy
Exclusion Criteria:
1. History of drug allergy
2. Secondary headaches such as epilepsy or other neurologic disorders
3. Systemic diseases such as asthma, diabetes mellitus , metabolic acidosis , renal stone and hepatic diseases
Age
From 5 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Street address
Yazd,Alem square
City
yazd
Postal code
Approval date
2011-11-08, 1390/08/17
Ethics committee reference number
65767/1/17/پ
Health conditions studied
1
Description of health condition studied
Migraine headache
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
Number of headache in a month
Timepoint
before and three months after treatment .
Method of measurement
asking from patient
2
Description
pediatric disability score of migraine headache
Timepoint
before and three months after treatment .
Method of measurement
asking from patient
3
Description
severity of headache
Timepoint
before and three months after treatment .
Method of measurement
asking from patient
Secondary outcomes
1
Description
Side effect
Timepoint
monthly until three months after treatment
Method of measurement
clinical exam
Intervention groups
1
Description
5mg/kg/day of oral topiramate for three months
Category
Prevention
2
Description
1mg/kg/day of oral propranolol for three months
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric neurology clinic of Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Dr.Razieh Fallah
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Dr.Fatemah Ezoddini
Street address
Yazd, Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Dr.razieh Fallah
Position
Pediatric neurologist-Assisstant professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Pediatric Ward
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
FALLAH@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)