This clinical trial before and after study is carried out with the aim of evaluating the prophylactic effect of Levetiracetam on pediatric migraine and its comparison with propranolol
Design
A clinical trial with control group, with parallel groups, randomized and 30 patients in each group
Settings and conduct
The study will be performed in Neurology clinic of Bouali Hospital of Sari and the patients are non-blinded.
Participants/Inclusion and exclusion criteria
Age 5 to 15 years, migraine attacks more than once a week causing the child's disability (PedMIDAS score > 20) and headache prophylaxis is required in the child
Intervention groups
In the intervention group, the Levetirastam tablet with brand name of Levebel made by Koobl Daroo Co. at a daily dose of 20 mg/kg is prescribed for 3 months and in control group, 0.5-1 mg/kg Propranol tablet made by the same company is prescribed in two divided doses.
Main outcome variables
After 3 months and then 6 months, the severity, duration, number of headache attacks per month, the rate of headache disability and the side effects of medications are evaluated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090412001808N5
Registration date:2018-03-22, 1397/01/02
Registration timing:registered_while_recruiting
Last update:2018-03-22, 1397/01/02
Update count:0
Registration date
2018-03-22, 1397/01/02
Registrant information
Name
Ali Abbaskhanian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1223 3010
Email address
aabbaskhanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-20, 1396/12/29
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of the effects of propranolol and levetiracetam to prevent migraine attacks in 5-15 year-old children
Public title
effects of propranolol and levetiracetam to prevent migraine attacks in children 5-15 year-old children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 5 to 15 years
migraine attacks
headache more than once a week
Headache causing a child's disability (PedMIDAS score more than 20)
Headache prophylaxis is required in the child
Exclusion criteria:
Underlying diseases such as asthma, liver disease, diabetes
Secondary headaches or other neurological disorders such as epilepsy
receiving medications for migraine over the past two months
History of sensitivity to propranolol and levetiracetam
history of propranolol and levetiracetam for migraine prophylaxis
renal dysfunction
Age
From 5 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized method is simple and by using random numbers' table
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
Ethics committee of Mazandaran University of Medical Sciences
Street address
Deputy of Science and Technology of Mazandaran University of Medical Sciences, Moallem square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
48178-44718
Approval date
2017-08-07, 1396/05/16
Ethics committee reference number
IR.MAZUMS.REC.1396.2937
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headache severity
Timepoint
The beginning of the study, the 3rd month and the 6th month
Method of measurement
Visual Analogue Scales (From a score of 1-10 that is scored by the child)
2
Description
Headache duration
Timepoint
The beginning of the study, the 3rd month and the 6th month
Method of measurement
minute
Secondary outcomes
1
Description
Number of migraine attacks per month
Timepoint
The beginning of the study, the 3rd month and the 6th month
Method of measurement
Number in the questionnaire
2
Description
Side effects of medication (Dizziness, drowsiness, weight loss, anorexia, memory impairment, imbalance, skin complications)
Timepoint
The 3rd month and 6th month
Method of measurement
Questionnaire
3
Description
Severity of disability due to headache
Timepoint
The beginning of the study, the 3rd month and the 6th month
Intervention group: In the intervention group, the Levetirastam tablet with brand name of Levebel made by Koobl Daroo Co. at a daily dose of 20 mg/kg is prescribed for 3 months.
Category
Prevention
2
Description
Control group: In control group, 0.5-1 mg/kg Propranol tablet made by Koobl Daroo Co. is prescribed in two divided doses for 3 months
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali hospital of Sari
Full name of responsible person
Ali Abbaskhanian
Street address
Bouali hospital, Pasdaran blvd., Sari, Iran
City
Sari
Province
Mazandaran
Postal code
48158-38477
Phone
+98 11 3334 2334
Email
aabbaskhanian@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeidi
Street address
Bouali hospital, Pasdaran Blv, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
48178 -44718
Phone
+98 11 3334 2334
Email
msaeedi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Shiva Shadani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Bouali hospital, Pasdaran blvd., Sari, Iran
City
Sari
Province
Mazandaran
Postal code
38477-48158
Phone
+98 11 3334 2334
Email
shiva_shadani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Abbaskhanian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Bouali hospital, Pasdaran blvd., Sari, Iran
City
Sari
Province
Mazandaran
Postal code
38477-48158
Phone
+98 11 3334 2334
Email
aabbaskhanian@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Shiva Shadani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Bouali hospital, Pasdaran blvd., Sari, Iran
City
Sari
Province
Mazandaran
Postal code
38477-48158
Phone
+98 11 3334 2334
Email
shiva_shadani@yahoo.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data is available
When the data will become available and for how long