Migraine is one of the most common paroxysmal disorders which can disable patients. In this study, we are going to compare the efficacy of cinnarizne (25 mg twice a day) versus sodium Valporate (200 mg twice a day) in migraine prophylaxis. A total of 98 migrainours who fulfill International Headache Criteria referred to neurology clinic of Emam Reza hospital of Kermanshah, will be randomly allocated into one of the two abovementioned groups. We will visit the patients every 4 weeks up to 12 weeks. Severity, duration and frequency of headache, amount of analgesic use and side effects of the drugs will be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102055729N2
Registration date:2011-03-04, 1389/12/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-03-04, 1389/12/13
Registrant information
Name
Arash Bostani
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6303
Email address
abostani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice_ chancellor for research of Kermanshah University of Medical Sciences and Health Services
Expected recruitment start date
2010-10-03, 1389/07/11
Expected recruitment end date
2011-11-22, 1390/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cinnarizine and sodium valporate in migraine prophylaxis
Public title
Comparison of cinnarizine and sodium valporate in migraine prophylaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: more than 4 and less than 10 attacks monthly, age at the onset of headache less than 50 years, age 18-65 years, discontinuation of other prophylactic drugs one month prior to the 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
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
Kermanshah University of Medical Sciences and Health Servises, Ethics Committee
Street address
Shahid Beheshti Boulevard, Kermanshah
City
Kermanshah
Postal code
Approval date
2010-09-22, 1389/06/31
Ethics committee reference number
پ/7/420/1900203
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
Intervention groups
1
Description
Cinnarizne tablet 25 mg twice a day orally, for 12 weeks
Category
Treatment - Drugs
2
Description
Sodium valporate tablets 200mg twice a day orally, for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospitl of Kermanshah
Full name of responsible person
Dr Arash Bostani
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
Emam Reza Hospitl of Kermanshah
Full name of responsible person
Dr Arash Bostani
Position
Neurologist/Assistant Professor
Other areas of specialty/work
Street address
Sorkhelijeh, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
+98 83 1427 6355
Email
arashbostani2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Emam Reza Hospitl of Kermanshah
Full name of responsible person
Dr Arash Bostani
Position
Neurologist/Assistant professor
Other areas of specialty/work
Street address
Sorkhelijeh, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
+98 83 1427 6355
Email
arashbostani2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Emam Reza hospital of Kermanshah
Full name of responsible person
Dr Aref Rajabi
Position
Resident of Neurology
Other areas of specialty/work
Street address
Sorkhelijeh, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
+98 83 1427 6355
Email
arefrajabi@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)