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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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History
# Registration date Revision Id
2 2018-12-28, 1397/10/07 75526
1 2017-07-17, 1396/04/26 25356
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  • Protocol summary

    (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 )
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    (1)اهداف: الف-اهداف اصلي طرح: بررسی اثربخشی و عوارض داروی لوتیراستام در مقایسه با دارونما در پیشگیری از سردرد میگرنی در کودکان 4-17 سال مراجعه کنند.به بیمارستان مرکز طبی کودکان ب-اهداف فرعي طرح: تعیین میزان اثربخشی لوتیراستام در شدت سردرد میگرنی در مقایسه با دارونمادر بیماران; تعیین میزان اثربخشی لوتیراستام در تناوب سردرد میگرنی در مقایسه با دارونمادر بیماران ; تعیین میزان اثربخشی لوتیراستام در مدت هر حمله در مقایسه با دارونمادر بیماران ; تعیین میزان اثربخشی لوتیراستام در روزهای بدون سردرد در هر ماه در مقایسه با دارونمادر بیماران ; مقایسه تحمل عوارض جانبی ناشی از لوتیراستام در مقایسه با دارونمادر بیماران پ- هدف کاربردی: میزان پاسخ دهی کودکان مبتلا به سردرد های میگرنی به داروی لوتیراستام تعیین شود تا بتوان هرچه زودتر این بیماری را در کودکان کنترل نمود. (2)طراحی: این مطالعه یک کارآزمایی بالینی دو سویه کور میباشد که در جمعیت کودکان 4 تا 17 ساله مبتلا به سردرد میگرنی تازه تشخیص داده شده انجام میگیرد. (3) نحوه انجام: در این مطالعه بیماران مراجعه کننده به درمانگاه اعصاب مرکز طبی کودکان با شکایت سردرد میگرنی به طور تصادفی در دو گروه درمانی قرار می گیرند. در گروه اول لوتیراستام و در گروه دوم دارونمابه مدت سه ماه برای بیماران تجویز گردیده و بیماران بر اساس معیارهای"Visual Analog Scale" و"visual pain scale"از نظر پاسخ به درمان، کاهش در تعداد سردرد، کاهش در مدت و شدت سردرد به صورت ماهانه مورد ارزیابی قرار میگیرند.همچنین اطلاعات مربوط به ادامه مصرف دارو، عدم پاسخدهی، عوارض دارویی یا عدم همکاری بیمار نیز ثبت می گردد. (4) شرکت کنندگان و معیارهای اصلی ورود و خروج: کودکان 4 تا 17 ساله معیار های ورود: تشخیص میگرن با یا بدون اورا که بر اساس شاخص های انجمن بین المللی سردرد باشد; کودکانی که یک یا بیش از یک بار در هفته دچار سردرد شده یا با ایجاد سردرد اختلال عملکرد شدید در فعالیت روزانه وتحصیلی داشته باشند; درمان قبلی برای برای پیشگیری یا درمان با شکست رو به رو شده باشد. معیارهای خروج: کودکان مبتلا به سردردهای مزمن یا دارای میگرن با عارضه; کودکان مبتلا به بیماری عصبی دیگر; کودکان با حساسیت قبلی شناخته شده به لوتیراستام; کودکان که به علت ایجاد عارضه شامل منع مصرف دارو شوند ; کودکان که به طور همزمان مبتلا به بیماری دیگر مثل بیماری بارز کبدی-کلیوی-قلبی-تیروئید هستند; کودکان که به طور همزمان داروی دیگری هم برای کنترل میگرن مصرف کنند. (5) مداخلات: تعداد68 بیمار واجد شرایط وارد مطالعه می شوند به بیماران در دو گروه مساوی به صورت کور و تصادفی توسط مسئول داروخانه مرکز طبی دارو یا دارونماداده می شود. به هر بیمار یک کد داده می شود و شماره آن ثبت می گردد.علائم و نشانه های بیمار در طول درمان ماهانه; اطلاعات مربوط به ادامه مصرف دارو; عدم پاسخ دهی; عوارض دارو یا عدم همکاری, در فرم مخصوص از قبل آماده شده ثبت می گردد.جهت مقابله با خروج نمونه ها ,محل تحویل دارو در داخل بیمارستان در نظر گرفته شد و موافقت ان از مسئولین کسب می شود. در گروه اول; 40-20 میلی گرم لوتیراستام به ازای هر کیلوگرم وزن روزانه در دودوز منقسم به مدت سه ماه به بیماران داده می شود و در گروه دوم; دارونما با همان مشخصات و شکل و رنگ و وزن تهیه و به مدت سه ماه به بیماران داده می شود. به بیماران اموزش داده می شود که هر ماه برای بررسی تعداد وشدت خملات, اختلال عملکرد, لزوم دارودرمانی حاد برای حملات شدید, در زمان مقرر به مرکز طبی مراجعه نمایند; همچنین حملات حاد سردرد در هر دو گروه با استامینوفن یا ایبوپروفن کنترل میشود. (6) متغیرپیامد اصلی: سردرد(بسامد,شدت و مدت)
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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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    بررسی اثربخشی و عوارض داروی لوتیراستام در مقایسه با دارونما در پیشگیری از سردرد میگرنی در کودکان 4-17 سال مراجعه کنند.
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    Randomized double-blind placebo-controlled trial
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    کارآزمایی بالینی دارای گروه کنترل, مبتنی بر جامعه, با گروه موازی, دوسویه کور, تصادفی شده
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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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    کار در مرکز طبی اطفال متعلق به دانشگاه علوم پزشکی تهران، ایران انجام گردید. درین کار لوتیراستام و پلاسبو به دو گروه بصورت تصادفی داده شد. از جهت کور سازی محققین, بیماران و خانواده آنها تا انتهای مطالعه کور بودند
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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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    کودکان 4 تا 17 ساله معیار های ورود: تشخیص میگرن با یا بدون اورا که بر اساس شاخص های انجمن بین المللی سردرد باشد: کودکانی که یک یا بیش از یک بار در هفته دچار سردرد شده یا با ایجاد سردرد اختلال عملکرد شدید در فعالیت روزانه وتحصیلی داشته باشند. معیارهای خروج: کودکان مبتلا به سردردهای مزمن یا دارای میگرن با عارضه; کودکان مبتلا به بیماری عصبی دیگر; آلرژی شناخته شده به لوتیراستام; کنتراندیکاسیون مصرف لوتیراستام با توجه به عوارض جانبی
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    Levetiracetam and placebo used in patients suffered from migraine
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    لوتیراستام و پلاسبو در کودکان با میگرن
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    Headache frequency and headache intensity
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    فرکانس و شدت سردرد

  • General information

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    2017-07-20, 1396/04/29
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    2018-04-09, 1397/01/20
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    2018-08-16, 1397/05/25
    Efficacy of levetiracetam in treatment of migraine headache
    Levetiractem for the prophylactic treatment of pediatric migraine
    تاثیر داروی لوتیراستام در درمان سردرد میگرنی
    تاثیر داروی لوتیراستام در پیشگیری سردرد میگرنی در اطفال
    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
    Comparison of the effectiveness of levetiracetam and placebo in improving migraine frequency and duration in children aged 4-17 years old.
    بررسی اثربخشی و عوارض داروی لوتیراستام در مقایسه بادارونمادر پیشگیری از سردرد میگرنی در کودکان 4-17 سال مراجعه کنند.به بیمارستان مرکز طبی کودکان
    مقایسه اثربخشی لوتیراستام وپلاسبو در بهبود فرکانس و شدت سردردهای میگرنی در کودکان ۴ تا ۱۷ سال
    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
    کودکان 4 تا 17 ساله
    تشخیص میگرن با یا بدون اورا بر اساس شاخص های انجمن بین المللی سردرد
    داشتن بیشتر از ۴ حمله میگرن در ماه یا وجود حمله میگرنی بسیار شدید و ناتوان کننده
    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)
    شرح حال سردرد خوشه ای، میگرن عارضه دار همی پلژیک یا سردردهای روزمره مزمن
    سردردهای مرتبط با اختلالات ساختاری مغز
    وجود نقص عصبی فوکال
    عدم پاسخ درمانی باوجود استفاده مناسب از حداقل ۳ نوع داروی پروفیلاکتیک میگرن
    حساسیت به لوتیراستام
    حاملگی
    وجود بیماریهای نورولوژیک دیگر مانند اپیلپسی
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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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    بیماران با قابلیت ورود به این کارآزمایی بالینی به نسبت ۱ به ۱ در دو گروه لوتیراستام و پلاسبو قرار گرفتند. فرآیند رندوم با استفاده از بلوکهای چهارتایی و با نرم افزار آماری انجام گردید
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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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    کدگذاری و تجویز لوتیراستام و پلاسبو توسط پرستاری انجام گرفت که هیچ اطلاعی درباره ویژگیهای کلینیکال بیماران نداشت. محققین، بیماران و خانواده آنها تا زمان باز کردن کدها در انتهای مطالعه کور بودند. لوتیراستام و پلاسبو در دسته بندی، سایز، شکل و ‌رنگ یکسان قرار داشتند.

  • Primary outcomes

    #1
    headache(frequency,severity,duration)
    Migraine frequency
    سردرد(فرکانس-شدت-مدت)
    فرکانس میگرن
    before initiation of trial and then monthly
    before initiation of trial and then per 4 weeks
    در اغاز مطالعه و سبس ماهیانه
    در اغاز مطالعه و سپس هر ۴ هفته
    specific questionnaire with interveiw
    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.
    برسشنامه مخصوص که با مصاحبه ومعاینه تکمیل میگردد
    فرکانس سردرد بصورت تعداد سردردها که مطابق با تعریف انجمن بین المللی سردرد باشد تعریف گردید. در هر گروه میانگین تعداد سردردها هر ۴ هفته بدست می آمد.
    #2
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    migraine intensity
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    شدت سردرد
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    before initiation of trial and then per 4 weeks
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    در اغاز مطالعه و سپس هر ۴ هفته
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    visual analogue scale (VAS)
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    (visual analogue scale (VAS

  • Secondary outcomes

    #1
    side effects
    Efficacy (More than 50% responder rate)
    عوارض جانبی دارو
    اثربخشی (درصد افراد با بیشتر از ۵۰٪ پاسخگویی به درمان)
    monthly visits and imidiatly according to alarms
    Baseline and the last 4 weeks of double-blind phase
    ماهانه بطور روتین همچنین بر اساس علایم هشدار در اسرع وقت
    پیش از شروع دارو و آخرین ۴ هفته فاز درمان
    Inter veiw,hystory
    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. ّ
    شرح حال و معاینه
    برای مشخص کردن این متغیر از پرسشنامه استفاده گردید تا تعداد سردردهای قبل از شروع دارو و تعداد سردردهای انتهای دوره درمان مشخص گردد. درصد افراد با بیش از ۵۰% پاسخگویی به درمان اثربخشی دارو را نشان می دهد. یک دارو درصورتی اثربخش است که هنگام مقایسه فرکانس سردرد پیش از شروع درمان و در انتهای درمان بیش از ۵۰% کاهش وجود داشته باشد. برای مشخص کردن آن از پرسشنامه استفاده گردید تا تعداد سردردهای قبل از شروع دارو و تعداد سردردهای انتهای دوره درمان مشخص گردد.
    #2
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    side effects
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    عوارض جانبی دارو
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    monthly visits and immediately after occurence of alarms
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    ماهانه بطور روتین همچنین بر اساس علایم هشدار در اسرع وقت
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    Taking history
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    شرح حال

  • Recruitment centers

    #1
    Name of recruitment center - English: Pediatric medical center
    Name of recruitment center - Persian: مرکز طبی کودکان
    Full name of responsible person - English: Mrs Frootan
    Full name of responsible person - Persian: خانم فروتن
    Street address - English: dr Gharib street, Keshavarz avenue
    Street address - Persian: بلوار کشاورز, خیابان دکتر قریب
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Pediatric medical center
    Name of recruitment center - Persian: مرکز طبی کودکان
    Full name of responsible person - English: Mrs Frootan
    Full name of responsible person - Persian: خانم فروتن
    Street address - English: dr Gharib street, Keshavarz avenue
    Street address - Persian: بلوار کشاورز, خیابان دکتر قریب
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1419733151
    Phone: +98 21 6693 5848
    Fax:
    Email: ashrafim@tums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Tehran university of medical sciense
    Name of organization / entity - Persian: معاونت پزوهشی دانشگاه علوم بزشکی تهران
    Full name of responsible person - English: Mrs Moammayee
    Full name of responsible person - Persian: خانم معمایی
    Street address - English: Cross the Ghods street, Keshavarz avenue
    Street address - Persian: بلوار کشاورز, نبش خیابان قدس
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Tehran university of medical sciense
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr Yunesian
    Full name of responsible person - Persian: خانم معمایی
    Street address - English: Cross the Ghods street, Keshavarz avenue
    Street address - Persian: بلوار کشاورز, نبش خیابان قدس
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 8163 3698
    Fax:
    Email: yunesian@tums.ac.ir
    Web page address:
    empty
    Public
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    Domestic
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    Academic
    معاونت پزوهشی دانشگاه علوم بزشکی تهران
    معاونت پژوهشی دانشگاه علوم پزشکی تهران

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Tehran university of medical sciense
    Name of organization / entity - Persian: دانشگاه علوم بزشکی تهران
    Full name of responsible person - English: Montazer-Hadi
    Full name of responsible person - Persian: هادی منتظر
    Position - English: Pediatric neurologist
    Position - Persian: فوق تخصص مغز و اعصاب اطفال
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pediatric medical center, dr Gharib street, Keshavarz avenue
    Street address - Persian: بلوار کشاورز, خیابان دکتر قریب, مرکز طبی کودکان
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 6693 1493
    Mobile: 00
    Fax:
    Email: h-mlotfelahi@razi.tums.ac.ir; hmontazer.hadi@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Tehran university of medical sciense
    Name of organization / entity - Persian: دانشگاه علوم بزشکی تهران
    Full name of responsible person - English: Montazerlotfelahi-Hadi
    Full name of responsible person - Persian: هادی منتظر لطف الهی
    Position - English: Pediatric neurologist
    Position - Persian: فوق تخصص مغز و اعصاب اطفال
    Latest degree: sub_specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pediatric medical center, dr Gharib street, Keshavarz avenue
    Street address - Persian: بلوار کشاورز, خیابان دکتر قریب, مرکز طبی کودکان
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1419733151
    Phone: +98 21 6693 1493
    Mobile: +98 913 351 2235
    Fax:
    Email: h-mlotfelahi@razi.tums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Tehran university of medical sciense
    Name of organization / entity - Persian: دانشگاه علوم بزشکی تهران
    Full name of responsible person - English: Montazer lotf Elahi-Hadi
    Full name of responsible person - Persian: هادی منتظرلطف الهی
    Position - English: Pediatric neurologist
    Position - Persian: فوق تخصص مغزواعصاب اطفال
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pediatric medical center, dr Gharib street, Keshavarz avenue
    Street address - Persian: بلوار کشاورز, خیابان دکتر قریب,مرکزطبی کودکان
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 6693 1493
    Mobile: +98 913 351 2235
    Fax:
    Email: h-mlotfelahi@razi.tums.ac.ir; hm.lotfelahi@yahoo.com; hmontazer.hadi@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Tehran university of medical sciense
    Name of organization / entity - Persian: دانشگاه علوم بزشکی تهران
    Full name of responsible person - English: Montazer lotf Elahi-Hadi
    Full name of responsible person - Persian: هادی منتظرلطف الهی
    Position - English: Pediatric neurologist
    Position - Persian: فوق تخصص مغزواعصاب اطفال
    Latest degree: sub_specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pediatric medical center, dr Gharib street, Keshavarz avenue
    Street address - Persian: بلوار کشاورز, خیابان دکتر قریب,مرکزطبی کودکان
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1419733151
    Phone: +98 21 6693 1493
    Mobile: +98 913 351 2235
    Fax:
    Email: h-mlotfelahi@razi.tums.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Tehran university of medical science
    Name of organization / entity - Persian: دانشگاه علوم بزشکی تهران
    Full name of responsible person - English: Montazer - Hadi
    Full name of responsible person - Persian: هادی منتظرلطف الهی
    Position - English: Pediatric neurologist
    Position - Persian: فوق تخصص مغزواعصاب اطفال
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pediatric medical center, dr Gharib street, Keshavarz avenue
    Street address - Persian: بلوار کشاورز, خیابان دکتر قریب, مرکزطبی کودکان
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 6693 1493
    Mobile: +98 913 351 2235
    Fax:
    Email: h-mlotfelahi@razi.tums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Tehran university of medical science
    Name of organization / entity - Persian: دانشگاه علوم بزشکی تهران
    Full name of responsible person - English: Montazer - Hadi
    Full name of responsible person - Persian: هادی منتظرلطف الهی
    Position - English: Pediatric neurologist
    Position - Persian: فوق تخصص مغزواعصاب اطفال
    Latest degree: sub_specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pediatric medical center, dr Gharib street, Keshavarz avenue
    Street address - Persian: بلوار کشاورز, خیابان دکتر قریب, مرکزطبی کودکان
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1419733151
    Phone: +98 21 6693 1493
    Mobile: +98 913 351 2235
    Fax:
    Email: h-mlotfelahi@razi.tums.ac.ir
    Web page address:

  • Sharing plan

    yes
    yes
    yes
    yes
    yes
    yes
    yes
    empty
    All collected information can be shared
    empty
    امکان اشتراک گذاری تمامی داده ها وجود دارد
    empty
    After the publication of results
    empty
    بعد از چاپ نتایج
    empty
    People working in academic institutions
    empty
    محققان شاغل در موسسات دانشگاهی و علمی
    empty
    Our data can be used with our permissions in academic classes
    empty
    اطلاعات در کلاسهای علمی می توانند به اشتراک گذاشته شوند
    empty
    Hadi Montazerlotfelahi with E-mail: h-mlotfelahi@razi.tums.ac.ir
    empty
    هادی منتظر لطف الهی با ایمیل h-mlotfelahi@razi.tums.ac.ir
    empty
    After a month we can share the data after complete understanding of aims
    empty
    بعد از فهمیدن اهداف تا ۱ ماه بعد از درخواست می تواند ارسال گردد

Protocol summary

Study aim
Determination of efficacy and side effects of levetiracetam versus placebo in prevention of migraine headache in 4-17 years old children
Design
Randomized double-blind placebo-controlled trial
Settings and conduct
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
Participants/Inclusion and exclusion 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 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;
Intervention groups
Levetiracetam and placebo used in patients suffered from migraine
Main outcome variables
Headache frequency and headache intensity

General information

Reason for update
Acronym
IRCT registration information
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
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
2017-07-20, 1396/04/29
Actual recruitment end date
2018-04-09, 1397/01/20
Trial completion date
2018-08-16, 1397/05/25
Scientific title
Comparison of the effectiveness of levetiracetam and placebo in improving migraine frequency and duration in children aged 4-17 years old.
Public title
Levetiractem for the prophylactic treatment of pediatric migraine
Purpose
Prevention
Inclusion/Exclusion criteria
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)
Age
From 4 years old to 17 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 68
Actual sample size reached: 68
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
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
Province
Tehran
Postal code
1417653761
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
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.

2

Description
migraine intensity
Timepoint
before initiation of trial and then per 4 weeks
Method of measurement
visual analogue scale (VAS)

Secondary outcomes

1

Description
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. ّ

2

Description
side effects
Timepoint
monthly visits and immediately after occurence of alarms
Method of measurement
Taking history

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
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 5848
Email
ashrafim@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran university of medical sciense
Full name of responsible person
Dr Yunesian
Street address
Cross the Ghods street, Keshavarz avenue
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
yunesian@tums.ac.ir
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
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
Tehran university of medical sciense
Full name of responsible person
Montazerlotfelahi-Hadi
Position
Pediatric neurologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric medical center, dr Gharib street, Keshavarz avenue
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 1493
Fax
Email
h-mlotfelahi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of medical sciense
Full name of responsible person
Montazer lotf Elahi-Hadi
Position
Pediatric neurologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric medical center, dr Gharib street, Keshavarz avenue
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 1493
Fax
Email
h-mlotfelahi@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Montazer - Hadi
Position
Pediatric neurologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric medical center, dr Gharib street, Keshavarz avenue
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 1493
Fax
Email
h-mlotfelahi@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected information can be shared
When the data will become available and for how long
After the publication of results
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Our data can be used with our permissions in academic classes
From where data/document is obtainable
Hadi Montazerlotfelahi with E-mail: h-mlotfelahi@razi.tums.ac.ir
What processes are involved for a request to access data/document
After a month we can share the data after complete understanding of aims
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