To determine the effectiveness of agomelatine on the severity, number of attacks, and days of migraine headaches
Design
Parallel randomized controlled trial design
Patients referred for migraine treatment, if they consent to enter the study, will be randomly assigned to one of the intervention or control groups. The groups are treated by agomelatine or placebo.
The sample size in this study will be 50 people for each group. The prescribing physician and the data collector will not be aware of the allocation method, and only the principal investigator will label the drug and placebo as A and B.
The addition of this study is 3
Settings and conduct
Ziyaian and Imam Hospital Neurology Clinic
patients were sampled consecutively over several months
Sampling among the eligible patients if they were satisfied
Participants/Inclusion and exclusion criteria
Patients with migraine headache between 18 and 60 years who referr to a hospital for treatment of migraine .
Patients with migraine who have other chronic diseases such as cardiovascular or brain diseases are not included in the study
Intervention groups
Receiving agomelatine 25 mg daily by the intervention group
Receiving placebo vitamin B1 with the same shape and design as the medicine of the intervention group in the amount of 25 mg
Main outcome variables
Severity of headache;
Number of headache attacks;
Midas;
Number of days with headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230303057599N1
Registration date:2023-05-24, 1402/03/03
Registration timing:retrospective
Last update:2023-05-24, 1402/03/03
Update count:0
Registration date
2023-05-24, 1402/03/03
Registrant information
Name
Mahdi Shafiee Sabet
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7707 8738
Email address
mshafiees@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
2021-09-23, 1400/07/01
Actual recruitment end date
2022-03-16, 1400/12/25
Trial completion date
empty
Scientific title
The effectiveness of agomelatine on the severity and numbers of migraine attacks in patients with migraine
Public title
effect of Agomelatin on the migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Migraine without aura without the use of preventive medicine
Exclusion criteria:
Pregnant woman
those taking certain medications
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
49
Randomization (investigator's opinion)
Randomized
Randomization description
based on random table
For this random assignment method in order to create groups with the same number
Half of the total number of people who are going to enter will be randomly selected from the table of random numbers. The random number between 0 and 4 get the word AB, and if it was between 5 and 9, BA is assigned to it, then according to the entry, people will be in one of the two groups - intervention or control.
For example, for a sample size of 60 people, if 30 random numbers are as follows:
396147224160811382693361771706
According to the above contract:
From left to right, equal to the number:
3, AB
Equivalent to 9, BA
Equivalent to 6, BA
Equation 1: AB
Equation 4: AB
Blinding (investigator's opinion)
Triple blinded
Blinding description
The Medications were made by the relevant company in the same shape and design and in the same size, and only the main researcher was aware of the type of Tablets. The neurologist who prescribed, as well as the data collector and the data analyst, were unaware of which intervention the patient had undergone.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital; Tehran University of Medical Sciences
Street address
Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2021-09-01, 1400/06/10
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.219
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
Severity and number of headache attacks
Timepoint
Three months after the intervention
Method of measurement
Checklist and interview
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group receives agomelatine 25 mg daily in tablet form for three months
Category
Treatment - Drugs
2
Description
Control group: This group receives vitamin B1 tablets with the same shape and design and weight of 25 mg equivalent to agomelatine for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Clinic of Imam Khomeini Hospital
Full name of responsible person
Shafiee Sabet Mahdi
Street address
Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6693 9010
Email
mshafiees@sina.tums.ac.ir
2
Recruitment center
Name of recruitment center
Ziaian Hospital
Full name of responsible person
Shafiee Sabet Mahdi
Street address
Ghazvin St.
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6813
Email
mshafiees@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
mshafiees@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shafiee Sabet Mahdi
Position
Faculty Member
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Aboozar St
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5575 1333
Email
mshafiees@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shafiee sabet Mahdi
Position
Faculty Member
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Aboozar St.
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6810
Email
mshafiees@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
shafiee sabet mahdi
Position
Faculty Member
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Aboozar st.
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5575 1333
Email
mshafiees@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available