Long-term Study of Rimegepant Safety for Treating Migraine in Children and Teens Aged 6 to 17 Years

What this Trial Is About

This research aims to evaluate the long-term safety of rimegepant in children and adolescents aged 6 to under 18 years for the acute treatment of migraine, including migraines with or without aura. The study focuses on understanding the safety profile of this medication when used over an extended period in this younger population. Participants receive rimegepant orally in doses of 75 mg, 50 mg, or 35 mg as orally disintegrating tablets. The study is open-label and single-group, meaning all participants receive the active drug. The treatment period lasts up to 58 weeks, during which the medication is assessed for safety and tolerability. Throughout the study, participants are monitored for adverse events, including serious side effects and lab abnormalities. Researchers track the frequency and severity of these events, including any liver-related issues. The study includes blood sampling and requires participants to distinguish migraine attacks from other headaches. The total participation spans up to 58 weeks to ensure comprehensive safety data collection.

Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine