title: A randomized trial of rizatriptan in migraine attacks in children.
abstract: OBJECTIVE
  To examine the efficacy of rizatriptan and the consistency of treatment response in migraine attacks of children and adolescents.
  
  
  METHODS
  We conducted a double-blind, placebo-controlled three-way crossover trial in patients ages 6 to 17 years diagnosed with migraine in two pediatric hospital outpatient clinics. Two doses of rizatriptan and a matching placebo were administered at home during three attacks. Rizatriptan dose was 5 mg for those with a body weight of 20 to 39 kg, and 10 mg for those with a body weight of 40 kg or more. The primary efficacy endpoint was headache relief by two grades on a five-grade face scale at 2 hours.
  
  
  RESULTS
  Ninety-six patients used all three treatments, 10 used two, and 10 only the first. At 2 hours, the primary endpoint was reached twice as often after both treatments of rizatriptan (first 74%, n = 71/96; second 73%, n = 70/96) as after placebo (36%, n = 35/96) (p < 0.001). Already at 1 hour, rizatriptan was clearly more effective as headache relief was reported by 50% (n = 48/96) and 55% (n = 53/96) of children after the first and the second dose of rizatriptan, compared to 29% (n = 28/96) after placebo (p = 0.004). Rizatriptan was superior at 3 and 4 hours, and the other endpoints also favored rizatriptan. Efficacy of rizatriptan was constant over the two treated attacks, and the findings were similar in children using the dose of 5 and 10 mg. No serious adverse effects were observed.
  
  
  CONCLUSIONS
  Oral rizatriptan is effective and well-tolerated for migraine attacks in children over age 6 years.
authors.affiliation: Hospital for Children and Adolescents, Department of Clinical Pharmacology, University of Helsinki, Finland.. Kati.Ahonen@fimnet.fi
authors.forename: K
authors.initials: K
authors.lastname: Ahonen
authors.forename: M L
authors.initials: ML
authors.lastname: Hämäläinen
authors.forename: M
authors.initials: M
authors.lastname: Eerola
authors.forename: K
authors.initials: K
authors.lastname: Hoppu
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000553:Ambulatory Care / Q000706:statistics & numerical data; D002648:Child; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005387:Finland / Q000453:epidemiology; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy* / Q000453:epidemiology*; D015990:Placebo Effect; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage; D014230:Triazoles / Q000008:administration & dosage*; D014363:Tryptamines / Q000008:administration & dosage*
chemical_list: D017366:Serotonin Receptor Agonists; D014230:Triazoles; D014363:Tryptamines; C093622:rizatriptan