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Long-term open-label safety study of rizatriptan acute treatment in pediatric migraineurs
David J Hewitt1, Eric Pearlman2, Mirja Hämäläinen3
1Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA.
Insights
Rizatriptan is safe and effective for long-term migraine treatment in adolescents. This study found it well-tolerated with consistent pain relief for pediatric migraineurs.
Area of Science:
- Neurology
- Pediatric Medicine
- Clinical Pharmacology
Background:
- Limited acute migraine treatment options exist for pediatric patients.
- Previous trials indicated rizatriptan's efficacy in single-attack pediatric migraine treatment.
- This study assessed rizatriptan's long-term safety and effectiveness for intermittent acute treatment.
Purpose of the Study:
- To evaluate the safety and tolerability of rizatriptan for the long-term acute treatment of migraine in pediatric patients.
- To assess the consistent treatment effect of rizatriptan over time in this population.
Main Methods:
- An open-label study involving pediatric migraineurs aged 12-17 years.
- Dosing was weight-based: 5 mg for <40 kg and 10 mg for ≥40 kg.
- Patients treated up to 8 migraine attacks monthly for 12 months, with a maximum of one dose per 24 hours.
Main Results:
- 606 pediatric patients were treated with rizatriptan (5 mg or 10 mg).
- The mean treatment duration was 292 days, with a mean of 20 doses taken.
- 66.0% experienced adverse events, 2.3% discontinued due to adverse events, and 2.6% had serious adverse events. Pain freedom at 2 hours was 46.3% and consistent over time.
Conclusions:
- Rizatriptan demonstrated good safety and tolerability in pediatric patients (12-17 years) for long-term migraine treatment.
- The medication provided a consistent treatment effect throughout the 12-month study period.
- Rizatriptan is a viable option for the acute management of migraine in adolescents.
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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