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A comparative study on the efficacy of levetiracetam and amitriptyline in childhood migraine; An open-label randomized controlled trial

Protocol summary

Study aim
Determine and compare the efficacy of levetiracetam and amitriptyline in the treatment of migraine headaches in children.
Design
Two arm parallel group open-label randomized controlled trial
Settings and conduct
The patients will be referred to our operator by the pediatric neurologists that are working at university clinics.Then, the patients and their parents will be registered and fill out prepared questionnaires. In the questionnaires; the frequency and severity and period of headaches should be recorded daily by the patients and their parents. These findings will be evaluated along with the quality of life (PedMidas)at the end of the pre-randomized phase, and also at the end of each month of treatment. Compared to the baseline records, if 50 percent or more decrease in symptoms is observed, it will be considered as a positive response to the medical treatment, and so, the treatment process will be continued until the end of the study.
Participants/Inclusion and exclusion criteria
All children with migraines who develop migraine attacks at least four times a month, or interfere with daily activities, are able to enter this study; Cases of epilepsy, the presence of migraine with a complication, hypersensitivity to tricyclic antidepressant drugs, the lack of ability to record data, the use of other prophylaxis other than levetiracetam and amitriptyline, severe psychiatric problems, taking analgesic more than 4 times a week for migraine headache, will not go into the study.
Intervention groups
Children aged 5 to 15 years old who are classified as migraine under the International Classification of Headache Disorders (ICHD) are placed in one of the treatment groups (levetiracetam or amitriptyline) and the response to the treatment will be evaluate.
Main outcome variables
Duration of headache, headache frequency, headache severity, quality of life score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171212037850N1
Registration date: 2018-05-01, 1397/02/11
Registration timing: retrospective

Last update: 2018-05-01, 1397/02/11
Update count: 0
Registration date
2018-05-01, 1397/02/11
Registrant information
Name
Gholamreza Jelodar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3445 6272
Email address
jelodar-g@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the efficacy of levetiracetam and amitriptyline in childhood migraine; An open-label randomized controlled trial
Public title
Levetiracetam in migraine headaches of children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of children with migraine headache with or without aura, at least two attack per week or four attack per month, so that the attacks cause them to consume the analgesics or interfere with everyday activities
Exclusion criteria:
Epilepsy Complicated migraine Not having the ability to record data related to the number, duration, and severity of headaches Use of other prophylactic drugs other than Levetiracetam and Amitriptyline Severe psychiatric problems like depression and ADHD Hypersensitivity to tricyclic anti depressants drugs Taking analgesic more than 4 times a week for migraine headache
Age
From 5 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
After the patients were selected for inclusion in the study, they would be randomly divided into two groups A and B, in the form of quadruple blocks using the Block Balanced Randomization Method. Neither researchers nor patients will know which patients will belong to which group and when administering the medicine, patients will be assigned to one of the groups A or B (Levetiracetam or Amitriptyline) on the basis of the block list.
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 Isfahan University of Medical Sciences
Street address
Imam Hossein Children's Medical Education Center, Imam Khomeini Blvd. Daneshgah Square
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Approval date
2018-01-31, 1396/11/11
Ethics committee reference number
IR.mui.rec.1396.3.781

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine

Primary outcomes

1

Description
Duration of headache
Timepoint
Before, one month later, two months later and three months after treatment began
Method of measurement
Daily Headache Registration Form

2

Description
Headache severity
Timepoint
Before, one month later, two months later and three months after treatment began
Method of measurement
Wong-Baker FACES Pain Rating Scale

3

Description
Headache frequency
Timepoint
Before, one month later, two months later and three months after treatment began
Method of measurement
Record daily diary of headache

4

Description
Improving the quality of life
Timepoint
Before, one month later, two months later and three months after treatment began
Method of measurement
PedMIDAS quality of life checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Levetiracetam with a starting dose of 10 mg / kg given at a dose of 20 mg / kg in a week. In children and adults, the maximum dose is 3000 mg per day before bedtime, given for three months.
Category
Treatment - Drugs

2

Description
Control group: Amitriptyline is given at a dose of 5 to 12 mg / day and increases to 0.25 mg / kg / day for 2 weeks to reach the required dose of 1 mg / kg / day. The drug is given as a single dose at night.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
pediatric neurology clinics of Isfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Ghazavi
Street address
Imam Hossein Children's Medical Education Center, Imam Khomeini Blvd. Daneshgah Square
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3316 1456
Email
jelodar-g@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mommadreza Ghazavi
Street address
Immam Khomeini
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3316 1456
Email
ghazavi@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Jelodar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No.102, Mikhak Ave., South Banafshe, Khane Isfahan
City
Isfahan
Province
Isfehan
Postal code
8194834476
Phone
+98 31 3421 8176
Email
jelodar-g@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Jelodar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No.102, Mikhak Ave., South Banafshe, Khane Isfahan
City
Isfahan
Province
Isfehan
Postal code
8194834476
Phone
+98 31 3421 8176
Email
jelodar-g@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Jelodar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 102, Mikhak Ave., South Banafshe, Khane Isfahan
City
Isfahan
Province
Isfehan
Postal code
8194834476
Phone
+98 31 3421 8176
Email
jelodar-g@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on the main consequence of sharing is possible.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Researche
From where data/document is obtainable
Gholamreza Jelodar jelodar-g@ajums.ac.ir 00989166133744
What processes are involved for a request to access data/document
Sending an email and mentioning the job, job position and purpose of the request
Comments
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