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.
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Authors | K Ahonen, M L Hämäläinen, M Eerola, K Hoppu |
Journal | Neurology
(Neurology)
Vol. 67
Issue 7
Pg. 1135-40
(Oct 10 2006)
ISSN: 1526-632X [Electronic] United States |
PMID | 16943370
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Serotonin Receptor Agonists
- Triazoles
- Tryptamines
- rizatriptan
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Topics |
- Administration, Oral
- Adolescent
- Ambulatory Care
(statistics & numerical data)
- Child
- Cross-Over Studies
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Finland
(epidemiology)
- Humans
- Male
- Migraine Disorders
(drug therapy, epidemiology)
- Placebo Effect
- Serotonin Receptor Agonists
(administration & dosage)
- Triazoles
(administration & dosage)
- Tryptamines
(administration & dosage)
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