Comparison of prophylactic efficacy of propranolol and pregabalin in headache control of 3 - 15 years old children with migraine in Mofid children hospital
This is a scientific study to answer the question of whether the drugs are effective Pregabalin and propranolol in preventing migraines? Is there any difference between them?In this study , 96 children three to fifteen years coming to Mofid nervous clinic that visit the International Headache Society criteria for migraine diagnosis enroled in this study and randomly divited into two 48 childs groups , who randomly treated with pregabalin or propranolol and 8 weeks later the frequency , severity and duration fo headache evaluated and compred in this two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012090910508N1
Registration date:2012-10-16, 1391/07/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-16, 1391/07/25
Registrant information
Name
MohammadKazem Bakhshandeh Bali
Name of organization / entity
Shahid Beheshti medical university
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 9625
Email address
dr.mk.bakhshandehbali@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Children neurology research center of Shahid Beheshti University of Medical Scinces
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prophylactic efficacy of propranolol and pregabalin in headache control of 3 - 15 years old children with migraine in Mofid children hospital
Public title
Comparison of prophylactic efficacy of propranolol and pregabalin in headache control of children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Children 3-15 years with migraine, coming to Mofid Children's Hospital, according to the International Headache Society criteria for migraine diagnosis
Exclusion criteria: History of anticonvulsant hypersensitivity
Age
From 3 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
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
Shahid Beheshti univercity Of Medical Sciences
Street address
Velenjak , Tehran
City
Tehran
Postal code
Approval date
2011-12-25, 1390/10/04
Ethics committee reference number
89-01-146-7555-6806
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Episodic and paroxysmal disorders
Primary outcomes
1
Description
Headache
Timepoint
1 and 3 months later
Method of measurement
Interview
Secondary outcomes
empty
Intervention groups
1
Description
We evaluate 96 children 3 to 15 years old coming to Mofid Children Hospital with complaint of headache who after history taking and examination the diagnosis established as migraine and hypersensitivity to anticonvulsants ruled out.Children randomly divided into two groups ( 1 and 2 ) .We treat children of group 1 with tablet of propranolol ( 10 to 20 miligram a day) used oral for at least 8 weeks and after 8 weeks since propranolol starting ,we compare the frequency , severity and period of headache in this group with group 2.
Category
Treatment - Drugs
2
Description
We evaluate 96 children 3 to 15 years old coming to Mofid Children Hospital with complaint of headache who after history taking and examination the diagnosis established as migraine and hypersensitivity to anticonvulsants ruled out.Children randomly divided into two groups ( 1 and 2 ) .We treat children of group 2 with capsule of pregabalin( 50 to 75 miligram a day ) used oral for at least 8 weeks and after 8 weeks since propranolol starting ,we compare the frequency , severity and period of headache in this group with group 1.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric neurology research center
Full name of responsible person
Doctor Mohammad Kazem Bakhshandeh Bali
Street address
No. 25 , Kamyar Lane , Shariati street , Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ghofrani
Street address
No. 25 , Kamyar Lane , Shariati street , Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Pediatric neurology research center
Full name of responsible person
Doctor Mohammad Kazem Bakhshandeh Bali
Position
Pediatric neurology fellow
Other areas of specialty/work
Street address
No. 25 , Kamyar Lane , Shariati street , Tehran
City
Tehran
Postal code
Phone
+212 2259625
Fax
Email
Dr.MK.Bakhshandehbali@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pediatric neurology research center
Full name of responsible person
Doctor Parvaneh Karimzadeh
Position
Pediatric neurology specialist
Other areas of specialty/work
Street address
No. 25 , Kamyar Lane , Shariati street , Tehran
City
Tehran
Postal code
Phone
+212 2259625
Fax
Email
Pkarimzadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pediatric Neurology Research Center
Full name of responsible person
Dr Mohammad Kazem Bakhshandeh Bali
Position
Pediatric Neurology Fellow
Other areas of specialty/work
Street address
No. 25 , Kamyar Lane , Shariati street , Tehran
City
Tehran
Postal code
Phone
+98 22259625
Fax
Email
Dr.MK.Bakhshandehbali@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)