Comparison of the efficacy of prophylaxis with Atorvastatin versus Sodium Valproate on intensity and frequency of migraine type headache in Iranian patients
The purpose of this study is to compare the efficacy of prophylaxis with Atorvastatin and Sodium Valproate in adult patients with diagnosis of migraine type headache based on International Headache Society criteria. In this prospective, randomized, triple blind, 2-armed parallel group clinical trial, 100 patients with diagnosis of migraine and will be recruited from neurology clinic, Imam Hussein hospital, Tehran, Iran. All subjects with history of prophylactic treatment for migraine will be excluded. After randomization of the subject, 50 subjects in group A will receive Atorvastatin 40mg once daily and 50 subjects in group B will receive Sodium Valproate 500mg once daily for 3 months. Primary outcome measures are comparison of frequency and intensity of migraine headaches in patients receiving Sodium Valproate as standard prophylactic regimen with Atorvastatin(time frame: baseline, 1, 2 and 3 months after intervention). Intensity of headache will be evaluated by Wong-Baker Faces Pain Rating Scale
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092410178N8
Registration date:2014-10-25, 1393/08/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-25, 1393/08/03
Registrant information
Name
Mohammad Sistanizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0087
Email address
sistanizadm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of prophylaxis with Atorvastatin versus Sodium Valproate on intensity and frequency of migraine type headache in Iranian patients
Public title
Comparison of Atorvastatin versus Sodium Valproate on prophylaxis of migraine type headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:all patients with diagnosis of migraine based on International Headache Society criteria. Exclusion criteria: other types of headache; administration of prophylactic treatment for migraine; pregnancy; breast feeding; sensitivity to Atorvastatin or Sodium Valproate.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Imam Hussein hospital
Street address
Shahid Madani Street
City
Tehran
Postal code
Approval date
2014-10-04, 1393/07/12
Ethics committee reference number
123456
Health conditions studied
1
Description of health condition studied
Migraine type headache
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
frequency of migraine type headaches
Timepoint
entrance to study, 1, 2 and 3 months after intervention
Method of measurement
history taking and patient's notes
2
Description
intensity of migraine headaches
Timepoint
entrance to study, 1, 2 and 3 months after intervention
Method of measurement
Wong-Baker Faces Pain Rating Scale
Secondary outcomes
1
Description
consumption of analgesics
Timepoint
entrance to the study, 1, 2 and 3 months after intervention
Method of measurement
history taking and patient's notes
Intervention groups
1
Description
Control: Sodium Valproate500 mg once daily for 3 months
Category
Treatment - Drugs
2
Description
Intervention: Atorvastatin 40 mg once daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology clinic, Imam Hussein hospital
Full name of responsible person
Omid Hesami
Street address
Shahid Madani Street .Imam Hussein hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Shams
Street address
Velenjak Street, Shahid Chamran High Way
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
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor / Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Postal code
Phone
+98 218800087
Fax
Email
sistanizadm@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Neurology, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Omid Hesami
Position
Assistant Professor / Neurology Specialist
Other areas of specialty/work
Street address
Shahid Madani street, Imam Hussein hospital
City
Tehran
Postal code
Phone
+98 21 7343 2548
Fax
Email
hesami.omid@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor/ Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)