migraine headache. migraine without aura or clasic migraine
Conditions
Interventions
Intervention 1: A- Intervention group: 34 patients that they have essential criteria will arrive at this investigation randomly after code
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,
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
Sponsors
Vice chancellor for research, Tehran university of medical sciense
Eligibility
Sex/Gender
All
Age
4 Years to 17 Years
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMontazerlotfelahi-Hadi
Tehran university of medical sciense
Outcome results
None listed