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 golestan hospital AHVAZ. A group of 80migrainours 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
Migraine
IRCT registration information
IRCT registration number:IRCT201011025076N1
Registration date:2011-03-01, 1389/12/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-01, 1389/12/10
Registrant information
Name
Alireza Yarahmadi
Name of organization / entity
Golestan Hospital-Jondi ShapourUniversity of Medical Science and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3012
Email address
yarahmadi_md@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Ahvaz University of Medical Sciences and Health Services
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2009-08-23, 1388/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of low dose topiramate and sodium valporate in migraine prophylaxis
Public title
Comparison of the efficacy of topiramate and sodium valporate in migraine headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Patient’s age between 20 and 45 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) minimal age:20 maximal age:45 sex:female
Age
From 20 years old to 45 years old
Gender
Female
Phase
2-3
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
Ethics committe of Joundi Shapour University of Medical Science Ahvaz
Street address
Ahvaz, Golestan, Joundi Shapour University of Medical Science and Medical Services
City
Ahvaz
Postal code
45-61355
Approval date
2010-03-08, 1388/12/17
Ethics committee reference number
4993//20/8/p
Health conditions studied
1
Description of health condition studied
Classic migraine
ICD-10 code
G43.1
ICD-10 code description
Classic(with aura)migraine
Primary outcomes
1
Description
Headache severity
Timepoint
On each episode of headache
Method of measurement
The patient registers the severity of her headaches in daily notes according to VAS(FROM 1 TO 10)and these notes are registered by physician monthly
2
Description
headache duration
Timepoint
On each headache episode
Method of measurement
The patient registers the duration of each headache episode and these data are registered by the physician monthly
3
Description
Headaches frequencies
Timepoint
Monthly
Method of measurement
According to patient's notes
4
Description
Analgesic consumption rate
Timepoint
Monthly
Method of measurement
According to patient's 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 weeks
Category
Treatment - Drugs
2
Description
Sodium valproate tablet(200 mg)twice a day orally for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital, Ahvaz
Full name of responsible person
Alireza Yarahmadi
Street address
Ahvaz, Golestan,Golestan Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Ahvaz Jondishapour University of Medical Sciences and Health Services
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Ahvaz, Golestan,Jondi Shapour University of Medical Science and Health Services
City
Ahvaz
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, Ahvaz Jondishapour 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
Ahvaz Golestan Hospital
Full name of responsible person
Dr.Alireza Yarahmadi
Position
Resident of Neurology
Other areas of specialty/work
Street address
No.3, Esfand st, Golestan, Ahvaz
City
Ahvaz
Postal code
61244-65
Phone
+98 61 1320 9024
Fax
+98 61 1374 3012
Email
Yarahmadi_md@yahoo.com; Yarahmadi_md@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan hospital, Jondi Shapour University of Medical Science and Health Services
Full name of responsible person
Dr.Seyed Ehsan Mohammadiani Nejad
Position
Neurologist/Assistant Professor/chairman
Other areas of specialty/work
Street address
No. 118, Kianpars st., Ahvaz
City
Ahvaz
Postal code
61324-67
Phone
+98 61 1374 3001
Fax
+98 61 1374 3012
Email
Mohammadiani_neuro@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan Hospital
Full name of responsible person
Dr. Vahid Abbasi
Position
Resident of Neurology
Other areas of specialty/work
Street address
No.6, Day street, Ahvaz
City
Ahvaz
Postal code
61322-12
Phone
+98 61 1374 3008
Fax
+98 61 1374 3013
Email
Abbasi_n@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)