This is a clinical trial and the aim of this study was evaluation of Topiramate effect in improvement of clinical status of migraine patients. 89 patients with these criteria were enrolled: diagnosed for migraine based on the International Headache Society (IHS) criteria by a neurologist, having headache not more than 14 days per month, a history of 3 to 12 attacks. The exclusion criteria were: non-migraine headaches such as tension and sinus headaches, severe depression and a history of medical diet failure. Topiramate 25 mg/d will be prescribed for them in the first week and will be increased 25 mg/d weekly up to 100 mg/d and the maximum dose continued for 3 months, then HIT6 (Headache impact test 6) and MIDAS (Migraine Disability Assessment Scale) were refilled for patients to estimate the grade of migraine headache.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011164786N2
Registration date:2010-12-19, 1389/09/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-19, 1389/09/28
Registrant information
Name
Seyed Ali Sonbolestan
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1233 1401
Email address
sonbolestan@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan university of medical sciences
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Topiramate in improvement of clinical status of migraineurs according to HIT6 and MIDAS questionnaires
Public title
The effect of Topiramate in migraine improvement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosed for migraine based on the International Headache Society (IHS) criteria by a neurologist, having headache not more than 14 days per month, a history of 3 to 12 attacks. Exclusion criteria: non-migraine headaches such as tension and sinus headaches, severe depression and a history of medical diet failure.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
89
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan neuroscience research center, Isfahan university of medical sciences
Street address
Hezar jerib St.
City
Isfahan
Postal code
Approval date
2010-10-30, 1389/08/08
Ethics committee reference number
051/24/1033
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
The clinical status of patient's migraine according to HIT6 questionnaire
Timepoint
beginning and end of the study (after 3 months)
Method of measurement
history and physical exam
2
Description
The clinical status of patient's migraine according to MIDAS questionnaire
Timepoint
beginning and end of the study (after 3 months)
Method of measurement
history and physical exam
Secondary outcomes
1
Description
side effects of Topiramate in patients
Timepoint
end of the study (after 3 months)
Method of measurement
history and physical exam
Intervention groups
1
Description
Topiramate 25 mg/d will be prescribed for the patients in the first week and will be increased 25 mg/d weekly (up to 100 mg/d) and the maximum dose will be continued for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery for research, Isfahan university of medical sciences
Full name of responsible person
Dr. Peiman Adibi
Street address
Hezar jerib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for research, Isfahan 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
Isfahan university of medical sciences
Full name of responsible person
Seyed Ali Sonbolestan
Position
Student
Other areas of specialty/work
Street address
hezar jerib st.
City
Isfahan
Postal code
Phone
+98 31 1627 3910
Fax
Email
sonbolestan@edc.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Dr. Mohammad reza Najafi
Position
Associated professor of Neurology
Other areas of specialty/work
Street address
Sofeh St., Alzahra hospital
City
Isfahan
Postal code
Phone
+98 31 1627 3910
Fax
Email
najafi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Seyed Ali Sonbolestan
Position
Other areas of specialty/work
Street address
City
Isfahan
Postal code
Phone
Fax
Email
sonbolestan@edc.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)