aims to compare the effects of two drugs,levetiracetam and sodium valpoate,on preventing migraine headache,and thus comparing the effects of these two drugs on improving quality of life,reducing the duration and number of migraine headache attacks
Design
The study population will be 100 patients referring to the clinic of Alavi Haspital in Ardabil City in 2017.These people are randomly divided into two distinct groups,and then studied.A group of 50 people will be prescribed levetiracetam.These subjects will be examined according to the pre-prepared questionnaire form the time of referral up to 3 months after administration of the drug in terms of intencity,duration and number of migraine headache attacks.The next group including 50 people will be prescribed sodium valproate and the criteria listed above will be examined.At the end,the obtained data will be campared between the two groups.
Settings and conduct
Patients referring to the clinic of Alavi hospital in Ardabil who were randomly assigned to two separate groups according to the pre- prepared questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria in this research include the age of 16 to 65 years old who will be candidate to achieve prophylaxis of migraine by being diagnosed with migraine headaches,and Exclusion criteria include pregnancy and lactation;liver and kidney failure;sedative medications;being smoker;and non-migraine headaches.
Intervention groups
effects of two drugs,levetiracetam and sodium valpoate,on preventing migraine headache.
Main outcome variables
improving quality of life,reducing the duration and number of migraine headache attacks.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171011036717N1
Registration date:2017-12-03, 1396/09/12
Registration timing:registered_while_recruiting
Last update:2017-12-03, 1396/09/12
Update count:0
Registration date
2017-12-03, 1396/09/12
Registrant information
Name
Parham Sedighnia
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3371 5498
Email address
p.sedighnia@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Arabil University of Medical Sciences,Vice Cancellor for Research
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-03-16, 1396/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effectiveness of Levetiracetam and Sodium Valproate in prevention of Migraine without aura
Public title
The effectiveness of Levetiracetam and Sodium Valproate in Migraine headache prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria:The age of 16 to 65 years old who will be candidate to achieve prophylaxis of migraine by being diagnosed with migraine headaches.
pregnancy and lactation
liver failure
kidney failure
sedative medication
non-migraine headaches
Exclusion criteria:
Exlusion criteria: pregnancy and lactation; liver and kidney failure; sedative medication; being smoker; non-migraine headaches.
Age
From 16 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Ardabil University of Medical Sciences