Assessment of efficacy and side effects of levetiracetam versus placebo in prevention of migraine headache in 4-17 years old children that will be refere to pediatric medical center
(1) Objective: (A) Main objective: Determination of efficacy and side effects of levetiracetam versus placebo in prevention of migraine headache in 4-17 years old children that will be refer to pediatric medical center (B) Accessory objectives: Determination of levetiracetam efficacy versus placebo in decreasing severity of migraine headache; determination of levetiracetam efficacy versus placebo in decreasing frequency of migraine headache; determination of levetiracetam efficacy versus placebo in decreasing duration of each migraine attack; determination of levetiracetam efficacy versus placebo in number of days in month them are free of headache. (C) Operational objective: Determination of children responsibility to levetiracetam in migraine headache for more rapid control of this disease in children. (2) Design: This investigation is a double blind randomized clinical trial that will be done in children with new recognized migraine headache that they are between 4 and 17 years old. (3) Setting and conduct: in this Investigation the patients with migraine headache that are referred to clinic of neurology in child medical center will be divided in tow groups randomly; we will advice levetiracetam in the first group and placebo in the second group for three months and patients will be evaluated monthly about response to treatment and decrease of headache frequency; duration and severity according to"visual analog scale" and "visual pain scale"; also the information about continuance of drug usage; resistance; side effects and noncompliance will be registered. consumption of other drug for migraine control concomitantly. (4) Participants including major eligibility criteria: Children between 4 to 17 years old Inclusion criteria: Diagnosis of migraine with or without aura according to international headache society criterion; severe educational or daily dysfunction with migraine headache; frequency of attacks= or > 1 times a week; failure of previous treatment Exclusion criteria: Chronic headache or complicated migraine; presence of other neural or systemic disorders; previous known allergy to levetiracetam; contraindication of drug due to occurrence of it's side effects; children that they suffer concomitantly any other systemic disease such as significant hepatic,renal,cardiac or thyroid disease;f frequency and severity of attacks, function disorder,necessity of drug therapy for acute attacks. (5) Intervention: 68 patient will be entered in this investigation, patients will be received drug or placebo randomly and blindly in 2 equal number groups by drug store assistant of pediatric medical center, each patient will be received a code number; patient,s signs and symptoms and information about complications, refractory and noncompliance will be recorded before initiation of investigation and in monthly forms after initiation of trial. In first group; drug will be administered 20-40mg/kg/day in 2 divided doses for 3 months; drug is levetiracetam that is new anti convulsive drug with minimal side effects. In second group; placebo with similarly form,color,weight,size,inter wall and other specifications will be administered for the same period.patients refer monthly to pediatric medical center for assessment; also acute migraine attacks will be treated with acetaminophen or Iboprofen. (6) Main outcome measures: Headache ( frequency, severity and duration )
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021632603N1
Registration date:2017-07-17, 1396/04/26
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-07-17, 1396/04/26
Registrant information
Name
Hadi Montazer Lotf Elahi
Name of organization / entity
Tehran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 1493
Email address
h-mlotfelahi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, tehran university of medical science
Expected recruitment start date
2017-06-10, 1396/03/20
Expected recruitment end date
2017-07-11, 1396/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of efficacy and side effects of levetiracetam versus placebo in prevention of migraine headache in 4-17 years old children that will be refere to pediatric medical center
Public title
Efficacy of levetiracetam in treatment of migraine headache
Purpose
Prevention
Inclusion/Exclusion criteria
Participants: Children between 4 and 17 years old. Inclusion criteria: Diagnosis of migraine with or without aura according to international headache society criterion; severe educational or daily dysfunction with migraine headache; frequency of attacks= or > 1 times a week; failure of previous treatment. Exclusion criteria: Chronic headache or complicated migraine; presence of other neural or systemic disorders; children with known allergy to levetiracetam; levetiracetam contraindication because of complications; presence of significant liver; kidney, heart or thyroid disease; consumption of other drug for migraine control concomitantly.
Age
From 4 years old to 17 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical science Ethics committee
Street address
Beside Ghods street, keshavarz avenue, Tehran
City
Tehran
Postal code
Approval date
2016-10-23, 1395/08/02
Ethics committee reference number
IR.TUMS.VCR.REC.1395-818
Health conditions studied
1
Description of health condition studied
migraine headache
ICD-10 code
G43.0
ICD-10 code description
migraine without aura or clasic migraine
Primary outcomes
1
Description
headache(frequency,severity,duration)
Timepoint
before initiation of trial and then monthly
Method of measurement
specific questionnaire with interveiw
Secondary outcomes
1
Description
side effects
Timepoint
monthly visits and imidiatly according to alarms
Method of measurement
Inter veiw,hystory
Intervention groups
1
Description
A- Intervention group: 34 patients that they have essential criteria will arrive at this investigation randomly after code reception and getting subscription from them.patients don,t know that they are in intervention or control group and interviewer is not aware that patient get drug or placebo and data collection will achieve with patient codding before starting of intervention. patients information (signs, symptoms, frequency and severity of headaches, duration of disease, duration of attacks and response to acute treatment) is registered in questionnaire. In this group Levetiracetam that exist in 250 and 500 mg tablets is administered at 20 mg/kg/day and is increased to 40 mg/kg/day in next visit if needed according to sign and symptoms. ( routinely half or one tablet twice a day according to child's weight ). treatment's duration is 3 months. patients are visited monthly and progressed note is complete for them and we exit them from study if complications happen or they dispense. Acute headache attacks is control with acetaminophen. Levetiracetam is the S- enantiomer of etiracetam with this chemical name: " S-alpha-ethyl-2-oxo-1-pyrolidin ". It's bioavailability is 100%; it's biological half life is 6-8 hrs and it has urinary excretion; it's formula is C8H14N2O2 and it's molar mass is 170.209 g/mol. Levetiracetam is an anti convulsion drug with little side effects and common side effects including: insomnia, somnolence, restlessness, mood or behavioral disorders and skin rash. This drug secrete in milk and it's use in pregnancy should be with caution. Levetiracetam as an anti convulsive drug is start at 20 mg/kg/day divided in 2 doses and is increased up to 60 mg/kg/day; it's use dose not interact with food; it's oral absorption is complete and rapid and arrives to appropriate blood level during 2 days. This drug exist in form of syrup, slow release tablets also intra venous form. we use in this study 250 and 500 mg tablets that are made in Iran (" Cobel daro company") with" Levebel" name. In pediatric medicine anti convulsive drugs are a group of relatively safe drugs in migraine headache prevention and Levetiracetam is a most safe drugs of them also there is a little investigations by Levetiracetam in migraine headache prevention.
Category
Treatment - Drugs
2
Description
B- control group: 34 patients that they have essential criteria will arrive at this investigation randomly after code reception and getting subscription from them.patients don,t know that they are in intervention or control group and interviewer is not aware that patient get drug or placebo and data collection will achieve with patient codding before starting of intervention. patients information (signs, symptoms, frequency and severity of headaches, duration of disease, duration of attacks and response to acute treatment) is registered in questionnaire. In this group Placebo is administered for patients. Placebo is exactly the same of 250 or 500 mg tablets of Levetiracetam(with shape, color, weight and size) and is made in "cobel daroo company". Placebo is administered for patients according to their weight at half or one tablet (small or medium size tablet); twice a day. treatment's duration is 3 months. patients are visited monthly and progressed note is complete for them and we exit them from study if complications happen or they dispense. Acute headache attacks is control with acetaminophen
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric medical center
Full name of responsible person
Mrs Frootan
Street address
dr Gharib street, Keshavarz avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran university of medical sciense
Full name of responsible person
Mrs Moammayee
Street address
Cross the Ghods street, Keshavarz avenue
City
Tehran
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, Tehran university of medical sciense
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
Name of organization / entity
Tehran university of medical sciense
Full name of responsible person
Montazer-Hadi
Position
Pediatric neurologist
Other areas of specialty/work
Street address
Pediatric medical center, dr Gharib street, Keshavarz avenue