Phase 3 Study of Atogepant Tablets to Prevent Chronic Migraine in Children and Teens Aged 12 to 17

What this Trial Is About

Researchers are evaluating the safety and effectiveness of atogepant, a medicine approved for preventing migraine in adults, in young participants aged 12 to 17 years who experience chronic migraine. The study aims to compare atogepant with a placebo, which looks like the medicine but contains no active drug. It focuses on monitoring side effects and changes in migraine frequency in this pediatric population. Participants will be randomly assigned to receive either atogepant or placebo tablets once daily for 12 weeks in a double-blind design, meaning neither participants nor doctors know who receives which treatment. After the treatment period, participants will be followed for an additional 4 weeks to observe ongoing effects. The study plans to enroll about 420 adolescents across approximately 70 sites worldwide. During the study, participants will attend regular clinic visits where researchers will assess treatment effects through daily diaries, medical exams, blood tests, side effect monitoring, and questionnaires. The main outcomes include the number of participants experiencing adverse events and changes in the average monthly number of migraine days. Secondary measures cover headache days, medication use, quality of life, and migraine-related disability. Total participation lasts about 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