Evaluation of serum levels of FGF-21 correlation with severity of headache and therapeutic response to sodium valproate in patients with migraine headache
Design
Prospective and open label clinical trial on 40 patients with migraine who candidate sodium valproate treatment.
Settings and conduct
Patients who referred to neurology clinic of Ibne Sina hospital with migraine headache diagnosis who candidate sodium valproate prophylaxis will be included. At baseline and end of the study period, the level of FGF-21, headache severity and treatment response according MIDAS evaluation will be recorded.
Participants/Inclusion and exclusion criteria
Adult patients ware aged more than 18 years with recently migraine headache (with or without aura) diagnosis and candidate receiving sodium valproate will be included.
exclusion criteria: other headache except migraine type, pregnancy, lactation, liver and kidney disease
Intervention groups
Adult patients are aged more than 18 years with recently migraine headache diagnosis (with or without aura) and candidate receiving therapeutic regimen of sodium valproate (1000 mg)
Main outcome variables
FGF-21serum level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190804044429N3
Registration date:2020-10-07, 1399/07/16
Registration timing:registered_while_recruiting
Last update:2020-10-07, 1399/07/16
Update count:0
Registration date
2020-10-07, 1399/07/16
Registrant information
Name
Monireh Ghazaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 6864
Email address
ghazaeianm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-04, 1399/01/16
Expected recruitment end date
2021-04-05, 1400/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Serum level of fibroblast growth factor 21 evaluation in patients with migraine headache treated by sodium valproate
Public title
fibroblast growth factor 21 in migraine headache
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with recently migraine headache (with or without aura)
candidate receiving prophylaxis regimen with sodium valproate
Exclusion criteria:
Headache sub-types other than migraine
Pregnancy
Breast feeding
Renal and Liver dysfunction
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
From each patients, two blood samples will be given for FGF-21 serum levels, liver enzymes and cell blood counts analysis
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
Mazandaran University of Medical Science
Street address
Ibn Sina Hospital, Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2020-04-02, 1399/01/14
Ethics committee reference number
IR.MAZUMS.REC.1399.034
Health conditions studied
1
Description of health condition studied
Migrain
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
FGF-21 serum levels
Timepoint
on 0 and 48 days of the study
Method of measurement
Elisa kite
2
Description
Headache severity
Timepoint
On 0 and 48 days of the study
Method of measurement
VAS scale
Secondary outcomes
1
Description
Clinical response evaluation
Timepoint
On 0 and 48 days of the study
Method of measurement
MIDAS questionnaire
2
Description
side effects profile
Timepoint
weekly
Method of measurement
history taking
Intervention groups
1
Description
Intervention group: Sodium valproate 500 mg every 12 hours (1000 mg daily) for 12 weeks
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina hospital
Full name of responsible person
Monireh Ghazaeian
Street address
Ibn Sina hospital, Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3011
Email
ghazaeianm@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Vice Chancellor for Research, Mazandaran University of Medical Sciences, Joybar 3way
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3448 4800
Email
majsaeedi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Pharmacit
Street address
Ibn Sina hospital, Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3011
Email
ghazaeianm@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3011
Email
ghazaeianm@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3011
Email
ghazaeianm@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of trial including analysis data and method of the study
When the data will become available and for how long
At the time of publication, the data of the study will be available.
To whom data/document is available
Academic researchers, medical team and scientific institutes
Under which criteria data/document could be used
For research and practical purposes
From where data/document is obtainable
Dr. Monireh Ghazaeian, Faculty of pharmacy, Mazandaran University of Medical Sciences
What processes are involved for a request to access data/document
The scientific responsible person of the study will reply to the request within 10 days.