Phase 3 Study to Evaluate Rimegepant for Acute Treatment of Moderate to Severe Migraine in Children and Adolescents Aged 6 to Under 18 Years

What this Trial Is About

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.

Randomized Study in Children and Adolescents With Migraine: Acute Treatment