Hawthorne

Researchers are evaluating the effectiveness and safety of rimegepant compared to a placebo for preventing migraines in children and adolescents aged 6 to under 18 years who experience episodic migraine. This Phase 3 study focuses on participants who have had migraines for at least six months with a limited number of headache and migraine days per month. The study aims to understand how well rimegepant works to reduce the number of migraine days over a 12-week period. Participants will receive either rimegepant in doses of 75mg or 50mg (two 25mg orally disintegrating tablets) or a matching placebo. The treatment is administered over a double-blind 12-week phase where neither the participants nor the researchers know which treatment is given. This setup helps ensure unbiased results when comparing the preventive effects of rimegepant against placebo. Throughout the study, participants will be monitored for changes in their migraine frequency, specifically the average number of migraine days per month from the start to the end of the 12 weeks. Evaluations include headache and migraine tracking, as well as assessments of daily activity disruption. Safety and side effects will also be closely observed to understand the medication's impact on young patients.