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Rizatriptan 5 mg for the Acute Treatment of Migraine in Adolescents: A Randomized, Double‐Blind, Placebo‐Controlled Study
Author(s) -
Winner Paul,
Lewis Donald,
Visser W. Hester,
Jiang Kaihong,
Ahrens Suzanne,
Evans Judith K.
Publication year - 2002
Publication title -
headache: the journal of head and face pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.14
H-Index - 119
eISSN - 1526-4610
pISSN - 0017-8748
DOI - 10.1046/j.1526-4610.2002.02013.x
Subject(s) - rizatriptan , placebo , medicine , nausea , tolerability , anesthesia , adverse effect , migraine , somnolence , sumatriptan , receptor , alternative medicine , pathology , agonist
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.