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Long-Term Open-Label Safety Study of Rizatriptan Acute Treatment in Pediatric Migraineurs

Authors


  • Conflicts of Interest: This study was funded by Merck Sharp & Dohme Corp. David J. Hewitt, Kathryn Connor, David Michelson, Paulette Ceesay, Christopher Assaid, Robert Bachman, Lyn Harper Mozley, Nicole Dupre, Nancy Strickler, Erin Mahoney, Christopher Lines, and Tony W. Ho are current or former employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., and own stock/stock options in Merck. Eric Pearlman, Mirja Hämäläinen, and Donald Lewis have received consulting fees from Merck.
  • Trial Registration: ClinicalTrials.gov NCT01004263.

Address all correspondence to D. Hewitt, Merck Sharp & Dohme Corp., UG 4C-18, PO Box 1000, North Wales, PA 19454-1099, USA, email david.hewitt@merck.com

Abstract

Objective

To evaluate the safety/tolerability of rizatriptan in the long-term acute treatment of migraine in pediatric patients.

Background

Acute migraine treatment options for children are limited. A recent single-attack trial demonstrated that rizatriptan is effective in eliminating migraine headache pain in this population. We evaluated the long-term safety and efficacy of rizatriptan when used for intermittent acute treatment.

Methods

Open-label study in pediatric migraineurs ages 12-17 years. Patients weighing <40 kg received rizatriptan (orally disintegrating tablet) 5 mg, and those weighing ≥40 kg received 10 mg. Patients could treat up to 8 mild/moderate/severe migraine attacks per month for up to 12 months. One dose of study medication was allowed in a 24-hour period.

Results

A total of 674 patients were enrolled, and 606 patients were treated with study medication (N = 583 for 10 mg, N = 23 for 5 mg). The mean duration in the study was 292 days, and the mean number of doses of study medication taken was 20. Over the course of the study within 14 days post-any-dose, 66.0% (400) of the 606 treated patients had any adverse event, 2.3% (14) discontinued due to an adverse event, 2.6% (16) had a serious adverse event, and 23.4% (142) had a triptan-related adverse event. Of the 16 patients with serious adverse events within 14 days post-any-dose, the adverse events in 3 were considered drug-related; all 3 patient's adverse events were classified as serious only because they were associated with an overdose (use of >1 dose of study medication in a 24-hour period). The mean percentage of patient's attacks with pain freedom at 2-hours post-dose was 46.3%; this was relatively consistent over time (Months 1-3 = 43.7%, Months 4-6 = 51.9%, Months 7-9 = 49.9%, Months 10-12 = 49.5%).

Conclusion

Rizatriptan was generally safe and well tolerated in the long-term acute treatment of migraine in pediatric patients aged 12-17 years and demonstrated a consistent treatment effect over time.

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