Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders

Jeffrey L. Seeburger, Frederick R. Taylor, Deborah Friedman, Lawrence Newman, Yang Ge, Ying Zhang, Carolyn M. Hustad, Jeanne LaSorda, Xiaoyin Fan, David Hewitt, Tony Ho, Kathryn M. Connor

Research output: Contribution to journalArticle

Abstract

Objective: The study was carried out to assess the efficacy and tolerability of rizatriptan orally disintegrating tablet (ODT) for treating acute migraine in patients who are non-responders to sumatriptan. Background: Many migraineurs report dissatisfaction with sumatriptan efficacy. It is unclear whether sumatriptan 100 mg non-responders will respond to other triptans. Methods: This was a randomized, placebo-controlled, double-blind study in adults with >1-year history of ICHD-II (International Classification of Headache Disorders, second edition) migraine who reported that they generally do not respond to sumatriptan (≥50% unsatisfactory response). In the baseline phase, participants treated a single moderate/severe migraine attack with open-label generic sumatriptan 100 mg. Those who continued to experience moderate/severe pain at two hours post-dose were eligible to enter the double-blind treatment phase, during which participants treated three migraine attacks in crossover fashion (two with rizatriptan 10-mg ODT, one with placebo) after being randomly assigned to one of three treatment sequences (1: 1: 1 ratio). The primary endpoint was two-hour pain relief. Results: A total of 102 (94%) participants treated at least one study migraine. Pain relief at two hours was significantly greater with rizatriptan compared with placebo (51% vs. 20%, p <.001). Response rates also favored rizatriptan on two-hour pain freedom (22% vs. 12%, p =.013) as well as 24-hour sustained pain relief (38% vs. 14%, p <.001) and sustained pain freedom (20% vs. 11%, p =.036). Treatment was generally well tolerated. Conclusion: Rizatriptan 10-mg ODT was superior to placebo at providing two-hour pain relief and two-hour pain freedom in the treatment of acute migraine in those who do not respond to sumatriptan 100 mg. Rizatriptan was generally well tolerated in this population.

Original languageEnglish (US)
Pages (from-to)786-796
Number of pages11
JournalCephalalgia
Volume31
Issue number7
DOIs
StatePublished - May 1 2011

Keywords

  • Migraine
  • clinical trial
  • headache
  • placebo
  • rizatriptan
  • sumatriptan

ASJC Scopus subject areas

  • Clinical Neurology

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  • Cite this

    Seeburger, J. L., Taylor, F. R., Friedman, D., Newman, L., Ge, Y., Zhang, Y., Hustad, C. M., LaSorda, J., Fan, X., Hewitt, D., Ho, T., & Connor, K. M. (2011). Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders. Cephalalgia, 31(7), 786-796. https://doi.org/10.1177/0333102410390399