Protocol summary
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Study aim
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Determination of efficacy and side effects of levetiracetam versus placebo in prevention of migraine headache in 4-17 years old children
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Design
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Randomized double-blind placebo-controlled trial
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Settings and conduct
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It conducted in Children’s Medical Center, Tehran University of Medical Sciences, Tehran, Iran. Levetiracetam and placebo were administered to patients in random. Investigators, patients and their parents were blinded during the study
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Participants/Inclusion and exclusion criteria
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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 one or more migraine headaches in a week or frequency of attacks more than 4 times in a month. 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;
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Intervention groups
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Levetiracetam and placebo used in patients suffered from migraine
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Main outcome variables
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Headache frequency and headache intensity
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017021632603N1
Registration date:
2017-07-17, 1396/04/26
Registration timing:
prospective
Last update:
2019-01-16, 1397/10/26
Update count:
1
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Registration date
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2017-07-17, 1396/04/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, tehran university of medical science
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Expected recruitment start date
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2017-06-10, 1396/03/20
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Expected recruitment end date
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2017-07-11, 1396/04/20
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Actual recruitment start date
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2017-07-20, 1396/04/29
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Actual recruitment end date
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2018-04-09, 1397/01/20
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Trial completion date
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2018-08-16, 1397/05/25
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Scientific title
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Comparison of the effectiveness of levetiracetam and placebo in improving migraine frequency and duration in children aged 4-17 years old.
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Public title
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Levetiractem for the prophylactic treatment of pediatric migraine
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Children aged 4-17 years
met the diagnostic criteria for pediatric migraine (with or without aura) as defined by the International Headache Society
having at least 4 migraineous episodes per month or have severe disabling or intolerable headache
Exclusion criteria:
History of cluster headache, hemiplegic migraine, or chronic daily headaches
Headaches related to structural brain lesions
Presence of focal neurologic deficit
No therapeutic response with at least 3 adequate trials of medication for headache prophylaxis
History of levetiracetam sensitivity
Pregnancy
Other neurological conditions (e.g. epilepsy)
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Age
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From 4 years old to 17 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
68
Actual sample size reached:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Eligible participants were randomly assigned to receive either levetiracetam or placebo in a 1:1 ratio by permuted block randomization (block sizes of four) via an interactive web response system.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The study medications were coded and administered by a nurse who was not informed about the clinical characteristics of cases. Investigators, participants, and their parents were blinded during the course of the study until the code was broken at the end of the trial. Packaging, size, shape, and placebo color were all similar to levetiracetam
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-10-23, 1395/08/02
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Ethics committee reference number
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IR.TUMS.VCR.REC.1395-818
Health conditions studied
1
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Description of health condition studied
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migraine headache
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ICD-10 code
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G43.0
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ICD-10 code description
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migraine without aura or clasic migraine
Primary outcomes
1
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Description
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Migraine frequency
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Timepoint
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before initiation of trial and then per 4 weeks
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Method of measurement
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Headache frequency was defined as the number of attacks that fulfilled the International Headache Society criteria. In each arm, we obtained the mean number of these episodes every 4 weeks after initiation of treatment.
2
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Description
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migraine intensity
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Timepoint
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before initiation of trial and then per 4 weeks
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Method of measurement
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visual analogue scale (VAS)
Secondary outcomes
1
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Description
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Efficacy (More than 50% responder rate)
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Timepoint
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Baseline and the last 4 weeks of double-blind phase
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Method of measurement
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For this purpose we used headache diary so the migraine frequency of baseline phase and the last 4 weeks of double-blind phase were achieved. >50% responder rate shows the efficacy of levetiracetam and placebo in the prevention of migraine. In fact, The drug was effective if it could decrease the migraine frequency by more than 50% in double-blind phase compared with the baseline frequency. ّ
2
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Description
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side effects
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Timepoint
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monthly visits and immediately after occurence of alarms
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Method of measurement
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Taking history
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Tehran university of medical sciense
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All collected information can be shared
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When the data will become available and for how long
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After the publication of results
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To whom data/document is available
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People working in academic institutions
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Under which criteria data/document could be used
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Our data can be used with our permissions in academic classes
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From where data/document is obtainable
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Hadi Montazerlotfelahi with E-mail: h-mlotfelahi@razi.tums.ac.ir
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What processes are involved for a request to access data/document
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After a month we can share the data after complete understanding of aims
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Comments
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