Topiramate and topiramate with omega-3 in pediatric migraine
Design
A randomized parallel group clinical trial
Settings and conduct
This study will be done to answer this question that whether or not topiramate with omega-3 capsule is more efficient than topiramate alone in reduction of monthly frequency, severity, and disability score of headaches of without vitamin D3 deficiency migraineur children. In a clinical trial, sixty 5-15 year old children with migraine headache, who would be referred to pediatric neurology clinic of Shahid Sadoughi University of Medical Sciences, Yazd, Iran and prophylactic therapy would be indicated in them, will be distributed randomly into two groups. In group I, 2 mg/kg/day of topiramate and in group II, 2mg/kg/day of topiramate and one capsule of omega-3 daily will be given. The drugs will be continued for two months and the children will be followed up monthly for two consecutive months. Primary outcomes include monthly frequency, severity, duration and disability score of migraine headache that will be compared before and after two months of treatment. Severity of headache will be assessed by asking each child to grade majority of headache pain on 10-point scale as no pain = scale of 0 and the most severe pain = 10. Headaches disability will be assessed by Pediatric Migraine Disability Assessment score questionnaire. Secondary outcome include more than 50 % of reduction in monthly headache frequency and clinical side effects.
The trial uses computer generated equal simple randomization by random numbers
Participants/Inclusion and exclusion criteria
5-15 year old children with migraine
Intervention groups
In group.I topiramate 2mg/kg/day , group.II topiramate 2mg/kg/day and omega-3 daily
Main outcome variables
Monthly frequency of headache
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20091027002639N23
Registration date:2020-03-31, 1399/01/12
Registration timing:registered_while_recruiting
Last update:2020-03-31, 1399/01/12
Update count:0
Registration date
2020-03-31, 1399/01/12
Registrant information
Name
Razieh Fallah
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
fallah@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-07, 1397/12/16
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of topiramate alone and topiramate with omega-3 fatty acid in prophylaxis of headaches in 5-15 year old children with migraine
Public title
Efficacy of topiramate and topiramate with omega-3 fatty acid in prophylaxis of children migraine headaches
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
children aged 5-15 years old
having migraine headache based on International Headache Society Criteria
having one or more headache attack per week
having moderate or severe headache disability
have not received omega-3 combinations within the past two months
did not use any migraine preventive therapy
Exclusion criteria:
secondary headaches such as epilepsy or other neurologic disorders
allergy to topiramat or omega-3
discontinuation of drugs usage for more than one week
irregullar drugs usage
Age
From 5 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 treatment groups and allocation ratio was 1:1 for the two groups.
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
of Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Street address
Central building of university, Bahonar square
City
Yazd
Province
Yazd
Postal code
8915836846
Approval date
2019-03-06, 1397/12/15
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.027
Health conditions studied
1
Description of health condition studied
migraine headache
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Monthly frequency of headache
Timepoint
Before and two months after treatment
Method of measurement
Asking from patient
2
Description
Severity of headache
Timepoint
Before and two months after treatment
Method of measurement
Asking from patient
3
Description
Duration of headache
Timepoint
Before and two months after treatment
Method of measurement
Asking from patient
4
Description
Pediatric Migraine Disability score
Timepoint
Before and two months after treatment
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Clinical side effects
Timepoint
Before and two months after treatment
Method of measurement
Clinical exam and asking from patients
Intervention groups
1
Description
Control group: Tablet of 25 and 50 mg of topiramate of Daroupakhsh Co, Iran in dosage of 2 mg/kg/day single dose for two months
Category
Treatment - Drugs
2
Description
Intervention group: One daily capsule of omega-3 from 21st Century Co, USA and and tablet of 25 and 50 mg of topiramate of Daroupakhsh Co, Iran in dosage of 2 mg/kg/day single dose for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Neurology Clinic of Shahid Sadoughi University of Medical Sciences, Yazd, Iran