Efficacy and tolerability of rizatriptan in pediatric migraineurs: Results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design

Tony W. Ho, Eric Pearlman, Donald Lewis, Mirja Hämäläinen, Kathryn Connor, David Michelson, Ying Zhang, Christopher Assaid, Lyn Harper Mozley, Nancy Strickler, Robert Bachman, Erin Mahoney, Christopher Lines, David J. Hewitt

Research output: Contribution to journalArticle

Abstract

Background: Treatment options for children and adolescents with migraine are limited. This study evaluated rizatriptan for the acute treatment of migraine in children and adolescents.Methods: Randomized, double-blind, placebo-controlled, parallel-group trial in migraineurs 6-17 years old with unsatisfactory response to nonsteroidal anti-inflammatory drugs or acetaminophen/paracetamol. The trial included a double-blind run-in with weight-based rizatriptan dosing (5 mg for <40 kg, 10 mg for >40 kg). In the Stage 1 run-in, patients were randomized in a ratio of 20:1 placebo:rizatriptan and were instructed to treat within 30 minutes of a moderate/severe migraine. Patients with mild/no pain after 15 minutes of treatment (responders) took no further study medication, whereas patients with moderate/severe pain (non-responders) proceeded to take study medication in Stage 2. Non-responders who received placebo in Stage 1 were randomized 1:1 to rizatriptan:placebo, whereas non-responders who received rizatriptan in Stage 1 were allocated to placebo in Stage 2. The primary efficacy endpoint was pain freedom at 2 hours after Stage 2 dose in 12-17-year-olds.Results: A higher proportion of 12-17-year-olds on rizatriptan had pain freedom at 2 hours compared with those on placebo: 87/284 (30.6%) versus 63/286 (22.0%), odds ratio = 1.55 [95% CI: 1.06 to 2.26], p = 0.025. Adverse events within 14 days of dose in 12-17-year-olds were similar for rizatriptan and placebo. The pattern of findings was similar in 6-17-year-olds.Conclusion: Rizatriptan demonstrated a statistically significant improvement over placebo in eliminating pain and was generally well tolerated in migraineurs aged 12-17 and 6-17 years.

Original languageEnglish (US)
Pages (from-to)750-765
Number of pages16
JournalCephalalgia
Volume32
Issue number10
DOIs
StatePublished - Jul 1 2012

Keywords

  • Rizatriptan
  • children
  • clinical trial
  • migraine
  • pediatric
  • triptans

ASJC Scopus subject areas

  • Clinical Neurology

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    Ho, T. W., Pearlman, E., Lewis, D., Hämäläinen, M., Connor, K., Michelson, D., Zhang, Y., Assaid, C., Mozley, L. H., Strickler, N., Bachman, R., Mahoney, E., Lines, C., & Hewitt, D. J. (2012). Efficacy and tolerability of rizatriptan in pediatric migraineurs: Results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design. Cephalalgia, 32(10), 750-765. https://doi.org/10.1177/0333102412451358