Westfield

Researchers are evaluating the long-term safety of rimegepant for treating acute migraine in children and adolescents aged 6 to under 18 years. This Phase 3, open-label study focuses on young individuals with a history of migraine with or without aura, aiming to understand the safety and tolerability of this treatment over time. Participants receive rimegepant orally in doses of 75 mg, 50 mg, or 35 mg orally disintegrating tablets (ODT) as needed for migraine attacks. The study monitors treatment over an extended period to assess ongoing safety and tolerability in a pediatric population. Throughout the study, participants will be regularly evaluated for any adverse effects, including serious events, events leading to discontinuation, and significant lab abnormalities. Safety assessments are conducted over 58 weeks, with careful monitoring to ensure participant well-being and collect comprehensive safety data.

This research aims to test the safety and effectiveness of BHV-3000 (rimegepant) compared to a placebo for treating moderate to severe migraine attacks in children and adolescents aged 6 to under 18 years. The study focuses on pediatric migraine, including attacks with or without aura, lasting more than 3 hours and occurring 1 to 8 times per month over the previous two months. Participants must be able to clearly distinguish migraine from other headaches and weigh more than 40 kg. Participants will receive either BHV-3000 (rimegepant) at doses of 75 mg or 50 mg as an orally disintegrating tablet (ODT) or a matching placebo. The study is randomized, double-blind, and placebo-controlled, designed to evaluate the acute treatment effect. Some participants may continue stable migraine preventive medications, but use of CGRP antagonist drugs is not allowed. The treatment phase will monitor responses to the study drug during migraine attacks. During the study, participants will be assessed for migraine pain relief two hours after dosing, measuring how many experience complete freedom from pain. Blood samples will be taken, and participants will be monitored for safety and side effects. The study excludes those with certain headache types, significant psychiatric or neurological conditions, recent surgeries, or other serious medical issues that could affect participation or safety. Overall, the study evaluates both the effectiveness and safety of rimegepant in a pediatric population over the course of migraine attacks.