Westfield

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.

Researchers are evaluating 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. This Phase 3 clinical trial focuses on acute migraine treatment in a pediatric population, aiming to measure pain freedom two hours after dosing and other migraine-related symptoms to understand how well the treatment works in this age group. Participants receive either BHV-3000 rimegepant 75 mg or 50 mg orally disintegrating tablet ODT, or a matching placebo tablet. The study uses a randomized, double-blind design where participants are assigned to one of these groups. The trial monitors the effects of the medication shortly after administration and compares outcomes between the active drug and placebo groups. During the study, participants will be assessed for pain relief, freedom from the most bothersome migraine symptoms, and need for rescue medication within 24 to 48 hours after treatment. Researchers will also evaluate sustained pain freedom and the ability to function normally following the migraine attack. Various outcome measures include pain and symptom assessments at 2 hours post-dose, along with tracking medication use and migraine impact. The trial lasts until the primary completion date in January 2029, with ongoing safety and efficacy monitoring throughout.