Phase 3 Randomized Trial of Rimegepant for Preventing Episodic Migraine in Children and Adolescents Aged 6 to Under 18 Years

What this Trial Is About

This research aims to evaluate the efficacy and safety of rimegepant compared to a placebo as a preventive treatment for migraine in children and adolescents aged 6 to under 18 years with episodic migraine. It focuses on reducing the frequency of migraine days over a 12-week period, particularly in young patients who experience mild to moderate disruption in daily activities due to migraine. The study is designed as a Phase 3 randomized, double-blind trial to assess this preventive approach. Participants will be randomly assigned to receive either rimegepant at doses of 75mg or 50mg two 25mg orally disintegrating tablets or a matching placebo with the same dosing options. The treatment phase lasts 12 weeks in a double-blind manner, followed by a safety and tolerability evaluation over a total of 72 weeks. The study includes sequential treatment with careful monitoring of migraine frequency and medication use during this period. Throughout the trial, participants will be monitored for migraine days per month, reduction in migraine frequency, and quality of life as measured by the Pediatric Quality of Life Inventory PedsQL. Researchers will also assess the use of acute migraine medications, hepatic-related adverse events, and overall safety. The primary outcome focuses on the change in migraine days during the 12-week treatment phase. Participants adherence and safety will be tracked throughout the treatment and follow-up periods, lasting up to nearly 10 years until study completion.

Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects