The object of this study is to Compare the effect of Propranolol and Topiramate in Pediatric Migraine prophylaxis. This study is a Single blind Randomized Controlled Clinical Trial on 60 Children at age of 5-15 yr in 2 equal group with Common Migraine IHS Criteria & History of Headache in last 6 months, no Drug history of Propranolol or Topiromate or other prophylactic drugs one month prior to study & with at least 2 episode of Migraine Headache in one month. Exclusion Criteia: Patient with Epilepsy or Movement Disorders & Appearing of drug side effects. In Intervention Group We've prescribed Topiramate 2mg/kg/day in 2 divided dose (oral) & In Control Group: Propranolol 0.5-1mg/kg/day in 2 divided dose (oral) for 2 months. At the end of the fourth and eighth weeks of treatment response to treatment according to the number, severity and complications are compared Pharmaceutical.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009221808N2
Registration date:2010-10-23, 1389/08/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-23, 1389/08/01
Registrant information
Name
Ali Abbaskhanian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1223 3010
Email address
aabbaskhanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences and Health Services
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-03-16, 1389/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Propranolol and Topiramate in Pediatric Migraine prophylaxis
Public title
Comparison the effect of Propranolol and Topiramate in Pediatric Migraine prophylaxis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: 1- Age between 5-15 yr 2- Patient with Common Migraine IHS criteria 3- History of Headache in last 6months 4- No Drug history of Propranolol or Topiromate 5- Discontinuation of other prophylactic drugs one month prior to study 6- At least 2 episode of Migraine Headache in one month. Exclusion Criteria: 1- Contraindications of Propranolol or Topiromate in pre-existing Disease 2- Patient with Epilepsy or Movement Disorders 3- Patient who don’t follow up their Treatment 4- Appearing of drug side effects.
Age
From 5 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Mazandaran University of Medical Sciences and Health Services
Street address
Imam Sq, Joybar 3way, Start of valiye asr highway
City
Sari
Postal code
Approval date
2010-10-06, 1389/07/14
Ethics committee reference number
89-92
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
Number of Migraine Headache episode
Timepoint
Before intervention, 4 & 8 weeks after intervention
Method of measurement
Questionnarie
Secondary outcomes
1
Description
Nausea & Vomiting
Timepoint
4 & 8 weeks after beginning of treatment
Method of measurement
Questionnaire
2
Description
Weight loss
Timepoint
4 & 8 weeks after beginning of treatment
Method of measurement
Questionnaire
3
Description
Drowsiness
Timepoint
4 & 8 weeks after beginning of treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
In Intervention Group: Topiramate 2mg/kg/day in 2 divided dose ( oral )
Category
Treatment - Drugs
2
Description
In Control Group : Propranolol 0.5-1mg/kg/day in 2 divided dose ( oral )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali Sina Hospital - Pediateric Department
Full name of responsible person
Street address
City
Sari
2
Recruitment center
Name of recruitment center
Tooba Pediatric Clinic
Full name of responsible person
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Center of Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Ahmad Ali Enayati
Street address
Moalem sq. Sari
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center of Mazandaran University of Medical Sciences and Health Services
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
Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Ali Abbaskhanian
Position
Pediatric Neourologist-Assistant Professor children
Other areas of specialty/work
Street address
Boalisina Hospital, Pediateric Department - Imam Sq - Pasdaran Blv
City
Sari
Postal code
Phone
+98 15 1223 3013
Fax
Email
aabbaskhanian@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Ali Abbaskhanian
Position
Pediatric Neourologist-Assistant Professor children
Other areas of specialty/work
Street address
Boalisina Hospital, Pediateric Department - Imam Sq - Pasdaran Blv
City
Sari
Postal code
Phone
+98 15 1223 3013
Fax
Email
aabbaskhanian@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Dr Hamidreza Sadeghi
Position
Pediatric Resident
Other areas of specialty/work
Street address
Boalisina Hospital, Pediateric Department - Imam Sq - Pasdaran Blv
City
Sari
Postal code
Phone
Fax
Email
Hamidxy@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)