This study will be done with aim to investigate the prophylactic effects of Levetiracetam on migraine in 4-14 years old children. This study is a single blind clinical trial. The study population will be included all patients with complaints of headache that admitted to Mohammad Kermanshahi hospital of Kermanshah city, the 30 eligible patients by available sampling method is selected and randomly will assigned to an experimental group. In the experimental group, before starting the study the questionnaire of determination of disability due to headache (PedMIDAS) will be provided, then levetiracetam tablets 20 mg per kg body weight), is prescribed and patients with a phone call and if its necessary by referring, every month follow up for at least 6 months and the questionnaire of determination of disability due to headache (PedMIDAS) every 3 months untill 6 months, will be checked. And the frequency and severity of headaches will be checked in compare with before start of treatment.
Inclusion criteria: diagnosis of migraine according to ICHD III; written and informed consent of the patient or his guardian.
Exclusion criteria: patients with abnormal imaging studies or EEG; a history of recent head trauma or drug abuse; having a secondary headache to infection (sinusitis, of otitis media, ...); and patients who coincident suffered from seizures and mood disorders ; being abnormal neurological examination
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101714333N44
Registration date:2015-11-03, 1394/08/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-03, 1394/08/12
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness and ineffectiveness of Prophylactic of Levetiracetam on migraine in 4-14 Years Old Children
Public title
Prophylactic Effects of Levetiracetam on Migraine in 4-14 Years Old Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of migraine according to ICHD III; written and informed consent of the patient or his guardian.
Exclusion criteria: patients with abnormal imaging studies or EEG; a history of recent head trauma or drug abuse; having a secondary headache to infection (sinusitis, of otitis media, ...); and patients who coincident suffered from seizures and mood disorders ; being abnormal neurological examination
Age
From 4 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2014-07-01, 1393/04/10
Ethics committee reference number
13871/پ/7/420
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headache frequency
Timepoint
Beginning of the study, 1 ,3 and 6 months after study
Method of measurement
With the question of patient
2
Description
The severity of migraine headaches
Timepoint
Beginning of the study, 1 ,3 and 6 months after study
Method of measurement
Based on questionnaire of determination of disability due to headache (PedMIDAS)
3
Description
Duration of headaches
Timepoint
Beginning of the study, 1 ,3 and 6 months after study
Method of measurement
With the question of patient
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group, before starting the study the questionnaire of disability due to headache (PedMIDAS) will be provided, then levetiracetam tablets 20 mg per kg body weight), is prescribed and patients with a phone call and if its necessary by referring, every month follow up for at least 6 months and the questionnaire of disability due to headache (PedMIDAS) every 3 months untill 6 months, will be checked. And the frequency and severity of headaches will be checked in compare with before start of treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Mohammad Kermanshah
Full name of responsible person
Bahare Yavari
Street address
Mohammad Kermanshahi Hospital, Crossroads of Shirkhorshid
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sedighi Mostafa
Position
Child Neurologist
Other areas of specialty/work
Street address
Mohammad Kermanshahi Hospital, Crossroads of Shirkhorshid
City
kermanshah
Postal code
6715847134
Phone
+98 83 3721 8204
Fax
Email
sedighi_mostafa@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)