Compression the efficacy of Topiramate and Propranolol in patients with migraine with Aura
Design
Patients are randomly divided into intervention groups and the study is design as a randomized and parallel group trial with double blinded outcome assessment. Randomisation was centralised based on simple randomization method using random digits table.
Settings and conduct
Thirty two patients with migraine with Aura in age group 18 to 65 years in Ahvaz Golestan hospital are studied into intervention groups (n=16). Participants, researchers responsible for data collection and analyses are blinded to the groups allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria are patients who are candidates for coronary artery bypass surgery in age group 40 to 65 years; The exclusion criteria are patients with systolic blood pressure below 90 mmHg, heart rate below 65 beats per minute, incidence of tension-type headache attacks in the last month, previous history of analgesia or migraine specific medication, history of known allergy to Topiramate or Propranolol, kidney stones and depression.
Intervention groups
In the intervention group (1), Topiramate will be started at a daily dose of 25 mg and increased to 100 mg daily, depending on patient tolerance. The duration of taking the drug is three months and in the intervention group (2), Propranolol at a dose of 20 mg is prescribed twice a day for three months.
Main outcome variables
The degree of disability according to Migraine Disability Assessment (MIDAS) scale questionnaire before and after 3 months of taking the drug will be assessed and compared in the two groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201031049208N1
Registration date:2020-11-08, 1399/08/18
Registration timing:registered_while_recruiting
Last update:2020-11-08, 1399/08/18
Update count:0
Registration date
2020-11-08, 1399/08/18
Registrant information
Name
Saba Farashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2925
Email address
farashi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compression the efficacy of Topiramate and Propranolol in patients with migraine with Aura
Public title
Compression the efficacy of Topiramate and Propranolol in patients with migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 18 to 65 years
History of migraine with Aura (according to the definition of the international classification of headache disorders)
Patients with the frequency of migraine attacks at least once a week
Exclusion criteria:
Systolic blood pressure below 90 mmHg
Heart rate below 65 beats per minute
Incidence of tension-type headache attacks in the last month
Previous history of analgesia or migraine specific medication
History of known allergy to Topiramate or Propranolol
History of kidney stone
History of depression
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly divided into two groups based on simple randomization method using random digits table. In this method, a collection of non-template numbers is randomly generated and arranged as a table. Even numbers for the intervention group (1) and the odd numbers for the intervention group (2) are considered. According to the number of patients, they are randomly assigned to one of the intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are informed about the purpose and method of study. After receiving informed consent, they are blinded to the study groups to unify patients in terms of their empathy sense. Researchers responsible for data collection and analyses will also blinded to the groups allocation for preventing personal viewpoint.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Research deputy, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd.
Intervention group (1): Topiramate will be started at a daily dose of 25 mg and increased to 100 mg daily, depending on patient tolerance. The duration of taking the drug is three months.
Category
Treatment - Drugs
2
Description
Intervention group (2): Propranolol at a dose of 20 mg is prescribed twice a day for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Seyed Ehsan Mohammadiani Nejad
Street address
Golestan Hospital, Farvardin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 2925
Email
Ehsanneuro@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Saba Farashi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Golestan Hospital, Farvardin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
009861329235893
Email
Farashi86.sf@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed Ehsan Mohammadiani Nejad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Golestan Hospital, Farvardin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
009861322235292
Email
Ehsanneuro@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Saba Farashi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Golestan Hospital, Farvardin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
009861329235893
Email
Farashi86.sf@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available