Migraine is one of the most common paroxysmal disorders which can disable patients. In this study we are going to compare the efficacy of low dose Topiramate (25 mg twice a day) versus sodium Valporate (200 mg twice a day) in migraine prophylaxis. Patients will be randomly selected in neurology clinic of Farabi & Emam Reza hospital of Kermanshah. A group of 56 migrainours who fulfill International Headache Criteria will be enrolled. The patients will be randomly allocated into one of two groups. We will visit them every 4 weeks up to 12 weeks. For evaluation of side effects, we will test CBC, diff, AST, ALT from all patients before and at the end of the treatment course. Severity, duration and frequency of headache, amount of analgesic use and side effects of the drugs in each group will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802171856N1
Registration date:2009-06-06, 1388/03/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-06-06, 1388/03/16
Registrant information
Name
Dariush Afshari
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 83 1835 0177
Email address
dafshari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
pro_vice_ chancellor for research of Kermanshah University of Medical Sciences and Health Services
Expected recruitment start date
2009-05-31, 1388/03/10
Expected recruitment end date
2010-09-25, 1389/07/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effects of low dose topiramate versus sodium valporate in migraine prophylaxis
Public title
comparison of topiramate and sodium valporate in migraine prophylaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: more than 4 and less than 10 attacks monthly, patient age at onset of headache less than 50 years, patient’s age between 18-65 years, discontinuation of other prophylactic drugs one month prior to study, interval between attacks more than 48 hours
Exclusion criteria: pregnancy and breast feeding, non-migraine headaches, overuse of medications in migraine attacks (consumption of NSAID, Ergots & Triptans more than 8 days a month), substance and alcohol abuse, illiteracy of patients and their family (unable to fill diaries)
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
56
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
Kermanshah University of Medical Sciences and Health Servises Ethical Comitte
Street address
Shahid Beheshti boulevard, Kermanshah
City
Kermanshah
Postal code
Approval date
2009-04-22, 1388/02/02
Ethics committee reference number
7/420/387
Health conditions studied
1
Description of health condition studied
Common migraine
ICD-10 code
G43.O
ICD-10 code description
Migraine without aura [common migraine]
2
Description of health condition studied
Classical migraine
ICD-10 code
G43.1
ICD-10 code description
Migraine with aura [classical migraine]
Primary outcomes
1
Description
Severity of headache
Timepoint
in each migraine attack
Method of measurement
patient will record the headache severity in daily notes as VAS (from 1 to 10) & physician registers them every 4 weeks
2
Description
Duration of migraine attack
Timepoint
in each migraine attack
Method of measurement
patient records the hours of headache in each attack , physician register them every 4 weeks
3
Description
Headache frequency
Timepoint
every 4 week
Method of measurement
According to patients daily notes
4
Description
Analgesic use
Timepoint
every 4 week
Method of measurement
According to patients daily notes
Secondary outcomes
1
Description
Clinical side effects
Timepoint
every 4 weeks
Method of measurement
According to patients daily notes
2
Description
Blood cell count & liver function test changes
Timepoint
before and at the end of treatment course
Method of measurement
lab tests
Intervention groups
1
Description
Topiramate tablet 25 mg twice a day orally, for 12 months
Category
Treatment - Drugs
2
Description
Sodium valporate tablets 200mg twice a day orally, for 12 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital of Kermanshah
Full name of responsible person
Dr Dariush Afshari
Street address
Ashayer boulevard, Dolat Abad, Kermanshah
City
Kermanshah
2
Recruitment center
Name of recruitment center
Emam Reza Hospitl of Kermanshah
Full name of responsible person
Dr Shabnam Rafizadeh
Street address
Sorkhelijeh, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Dr Farid Najafi
Street address
Shahid Beheshti boulevard, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research, Kermanshah 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
Farabi hospital
Full name of responsible person
Dr Dariush Afshari
Position
Neurologist/assistant professor/chairman
Other areas of specialty/work
Street address
Ashayer boulevard, Dolat Abad, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1826 4512
Fax
Email
dafshari@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farabi hospital
Full name of responsible person
Dr Dariush Afshari
Position
Neurologist/assistant professor/chairman
Other areas of specialty/work
Street address
Ashayer bulvard Dolat Abad Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1826 4512
Fax
Email
dafshari@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Emam Reza hospital
Full name of responsible person
Dr Shabnam Rafizadeh
Position
Resident of neurology
Other areas of specialty/work
Street address
Sorkhelijeh, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
sh.rafizadeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)