A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age

What this Trial Is About

Migraine is a condition that often causes moderate to severe headaches on one side of the head, sometimes accompanied by symptoms like throbbing, nausea, vomiting, and sensitivity to light and sound. This research aims to evaluate the safety and effectiveness of atogepant compared to a placebo in preventing chronic migraine in participants aged 12 to 17 years. Atogepant is already approved for adults and is now being studied for younger patients to understand its impact on this age group. Participants will be randomly assigned to receive either atogepant or a placebo, both given as oral tablets once daily for 12 weeks. The study is designed to be double-blind, so neither the participants nor the doctors will know who receives the active medicine or the placebo. After the 12-week treatment period, participants will be followed for an additional 4 weeks for further observation. During the study, participants will attend regular visits at a hospital or clinic where they will complete daily diaries, undergo medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure the number of participants experiencing adverse events and changes in monthly migraine days, among other outcomes. The total participation time, including treatment and follow-up, will be approximately 16 weeks.

A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years