The authors are saddened to report the death of our colleague and co-author Don Lewis shortly before this paper was submitted.
Long-Term Open-Label Safety Study of Rizatriptan Acute Treatment in Pediatric Migraineurs
Article first published online: 18 OCT 2012
© 2012 American Headache Society
Headache: The Journal of Head and Face Pain
Volume 53, Issue 1, pages 104–117, January 2013
How to Cite
Hewitt, D. J., Pearlman, E., Hämäläinen, M., Lewis, D., Connor, K. M., Michelson, D., Ceesay, P., Assaid, C., Bachman, R., Harper Mozley, L., Dupre, N., Strickler, N., Mahoney, E., Lines, C. and Ho, T. W. (2013), Long-Term Open-Label Safety Study of Rizatriptan Acute Treatment in Pediatric Migraineurs. Headache: The Journal of Head and Face Pain, 53: 104–117. doi: 10.1111/j.1526-4610.2012.02285.x
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.
- Issue published online: 8 JAN 2013
- Article first published online: 18 OCT 2012
- Manuscript Accepted: 7 AUG 2012
- Merck Sharp & Dohme Corp
- clinical trial
To evaluate the safety/tolerability of rizatriptan in the long-term acute treatment of migraine in pediatric patients.
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.
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.
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%).
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.