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IRCT2017021632603N1 IRCT 2017-07-17 Vice chancellor for research, Tehran university of medical sciense Levetiractem for the prophylactic treatment of pediatric migraine Comparison of the effectiveness of levetiracetam and placebo in improving migraine frequency and duration in children aged 4-17 years old. 2017-06-10 anticipated 68 Complete https://irct.ir/trial/25356 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 2-3 migraine headache. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All collected information can be shared When: After the publication of results To whom: People working in academic institutions Conditions: Our data can be used with our permissions in academic classes Where to obtain: Hadi Montazerlotfelahi with E-mail: h-mlotfelahi@razi.tums.ac.ir How to obtain: After a month we can share the data after complete understanding of aims Comments:
public Montazerlotfelahi-Hadi
Pediatric medical center, dr Gharib street, Keshavarz avenue
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6693 1493 h-mlotfelahi@razi.tums.ac.ir Tehran university of medical sciense scientific Montazer lotf Elahi-Hadi
Pediatric medical center, dr Gharib street, Keshavarz avenue
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6693 1493 h-mlotfelahi@razi.tums.ac.ir Tehran university of medical sciense Iran (Islamic Republic of) 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 4 years 17 years Both 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) G43.0 migraine without aura or clasic migraine Treatment - Drugs Treatment - Drugs 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. 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 Migraine frequency. Timepoint: before initiation of trial and then per 4 weeks. Method of measurement: 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. Migraine intensity. Timepoint: before initiation of trial and then per 4 weeks. Method of measurement: visual analogue scale (VAS). Efficacy (More than 50% responder rate). Timepoint: Baseline and the last 4 weeks of double-blind phase. Method of measurement: 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. ّ. Side effects. Timepoint: monthly visits and immediately after occurence of alarms. Method of measurement: Taking history. Vice chancellor for research, Tehran university of medical sciense Approved 2016-10-23 Ethics committee of Tehran university of medical science Beside Ghods street, keshavarz avenue, Tehran Tehran Tehran Iran (Islamic Republic of)