Long-Term Safety and Tolerability of Rizatriptan for Intermittent Acute Treatment of Migraine in Pediatric Migraineurs (P03.232)

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 was statistically significantly more effective than placebo in eliminating pain in this population. We evaluated the long-term safety and efficacy of rizatriptan for intermittent acute migraine treatment. Design/Methods: Open-label study in pediatric migraineurs ages 12-17yrs. Patients weighing 1 dose of study medication in a 24-hour period was considered an overdose, and any AE associated with an overdose was automatically classified as serious. Results: 606 patients 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 study-medication doses taken was 20. Over the course of the study within 14 days post-any-dose, 400/606 (66.0%) patients had any AE, 14/606 (2.3%) discontinued due to an AE, 16/606 (2.6%) had a serious AE, and 142/606 (23.4%) had a triptan-related AE. Of the 16 patients with serious AEs, the AEs in 3 were considered drug-related; all 3 patient9s AEs were classified as serious because they were associated with an overdose. The mean percentage of patient9s attacks with pain freedom at 2-hours postdose 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%). Conclusions: Rizatriptan was generally safe and well-tolerated in the long-term acute treatment of migraine in pediatric patients age 12-17 years, and demonstrated a consistent treatment effect over time. Supported by: Merck & Co., Inc. Disclosure: Dr. Hewitt has received personal compensation for activities with Merck & Co., Inc. as an employee. Dr. Pearlman has received personal compensation for activities with GSK, Merck, Allergan, and Nautilus Pharmaceuticals as a consultant.Dr. Pearlman has received research support from GSK, Merck, and AstraZenenca. Dr. Lewis has received personal compensation for activities with Merck, Astra Zeneca, and GlaxoSmithKline.Dr. Lewis has received research support from Abbott, Astra Zeneca, Almirall, GlaxoSmithKline, Merck, and Ortho-McNeil. Dr. Hamalainen has received personal compensation for activities with Merck. Ms. Connor has received personal compensation for activities with Merck & Co., Inc. Ms. Connor holds stock and/or stock options in Merck & Co., Inc. Dr. Michelson has nothing to disclose. Dr. Ceesay has received personal compensation for activities with Merck & Co., Inc. Dr. Ceesay holds stock and/or stock options in Merck & Co., Inc. Mr. Bachman has received personal compensation for activities with Merck & Co., Inc. as an employee. Mr. Bachman holds stock and/or stock options in Merck & Co., Inc. Dr. Harper-Mozley has received personal compensation for activities with Merck as an employee.Dr. Harper-Mozley holds stock and/or stock options in Merck. Dr. Dupre has received personal compensation for activities with Merck as an employee.Dr. Dupre holds stock and/or stock options in Merck. Ms. Strickler has received personal compensation for activities with Merck & Co., Inc., as an employee. Ms. Strickler holds stock and/or stock options in Merck & Co., Inc. Dr. Mahoney has received personal compensation for activities with Merck & Co, Inc. as an employee. Dr. Mahoney holds stock and/or stock options in Merck & Co, Inc. Dr. Lines has received personal compensation for activities with Merck as an employee.Dr. Lines holds stock and/or stock options in Merck. Dr. Ho has received personal compensation for activities with Merck & Co., Inc. as an employee.Dr. Ho holds stock and/or stock options in Merck & Co., Inc.