A complete list of the investigators of the Rizatriptan Adolescent Study Group appears at the end of this article.
Rizatriptan 5 mg for the Acute Treatment of Migraine in Adolescents: A Randomized, Double-Blind, Placebo-Controlled Study
Article first published online: 23 JAN 2002
Headache: The Journal of Head and Face Pain
Volume 42, Issue 1, pages 49–55, January 2002
How to Cite
Winner, P., Lewis, D., Visser, W. H., Jiang, K., Ahrens, S., Evans, J. K. and On Behalf Of The Rizatriptan Adolescent Study Group (2002), Rizatriptan 5 mg for the Acute Treatment of Migraine in Adolescents: A Randomized, Double-Blind, Placebo-Controlled Study. Headache: The Journal of Head and Face Pain, 42: 49–55. doi: 10.1046/j.1526-4610.2002.02013.x
- Issue published online: 23 JAN 2002
- Article first published online: 23 JAN 2002
- Accepted for publication September 20, 2001.
Objective.—To investigate the tolerability and efficacy of rizatriptan 5 mg in adolescent migraineurs.
Methods.—Randomized, double-blind, placebo-controlled study. Patients aged 12 to 17 years received rizatriptan 5 mg (n=149) or placebo (n=147) for a moderate or severe headache and for up to two recurrences. Headache severity, presence or absence of associated symptoms, and functional disability were assessed over a 4-hour postdose period, and any adverse events were recorded. The primary efficacy measure was pain-free status at 2 hours postdose.
Results.—Rizatriptan 5 mg was well tolerated. The most commonly reported adverse events (all with incidence of 5% or less) among patients receiving rizatriptan were dry mouth, dizziness, asthenia/fatigue, nausea, and somnolence. The percentage of patients pain-free at 2 hours was 32% for rizatriptan 5 mg versus 28% for placebo (P=.474). The percentage of patients with pain relief (reduction of predose pain intensity to mild or none) at 2 hours was 66% for rizatriptan versus 56% for placebo (P=.079). Placebo response rates were higher than those typically observed in previous studies of rizatriptan in adults. Compared with placebo, rizatriptan significantly improved functional disability at 1.5 and 2 hours, and nausea at 1 and 1.5 hours. Post hoc analysis showed a significant benefit of rizatriptan versus placebo in the percentage of patients who had pain relief when their migraine attacks were treated on weekends (65% versus 36%, P=.046) compared with weekdays (66% versus 61%, P=.365), and the weekend placebo response rate was similar to that seen in adults.
Conclusions.—Rizatriptan 5 mg was well tolerated and effective on some measures when used in adolescents for the treatment of a migraine attack.