Franklin

Researchers are evaluating the safety and effectiveness of low-dose and high-dose atogepant in children and adolescents aged 6 to 17 who experience episodic migraine. Migraines are moderate to severe headaches often accompanied by symptoms such as throbbing pain, nausea, and sensitivity to light and sound. While several treatments exist for adults, options for younger patients are limited, making this Phase 3 study important to understand how atogepant works in this younger population. Participants aged 6 to 17 will be randomly assigned to one of six groups to receive either placebo, low-dose atogepant, or high-dose atogepant tablets taken once daily by mouth for 12 weeks. The exact doses for children aged 6 to 11 will be decided after a pharmacokinetic substudy. After 12 weeks, participants may either have a follow-up visit 4 weeks after stopping the treatment or join an extension study to continue taking atogepant for an additional 52 weeks. During the study, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and to monitor for any side effects. They will also complete questionnaires to evaluate how treatment affects their migraines. The main outcomes measured are changes in the number of monthly migraine days over 12 weeks and the number of participants experiencing adverse events during the first 16 weeks. About 450 participants will be enrolled across roughly 100 sites worldwide.

Migraine is a common neurological disorder causing moderate to severe headaches, often with nausea, vomiting, and sensitivity to light and sound. It is especially disabling in children and adolescents. This trial evaluates the safety and effectiveness of ubrogepant, a drug approved for adults, for the acute treatment of migraine in children and adolescents aged 6 to 17 years. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial. Participants aged 6 to 11 years in a pharmacokinetic (PK) cohort will receive one of two doses of ubrogepant to determine the best dose for the main study. In the main study, children and adolescents will be randomized to receive either a low or high dose of ubrogepant or a placebo, with a one in three chance of receiving placebo. The study treatment is given as oral tablets during qualifying migraine attacks, with an option for a second dose or rescue medication at least 2 hours after the initial dose if the headache remains moderate or severe. Approximately 1059 participants will be enrolled across about 120 sites in the United States. Participants will attend regular hospital or clinic visits throughout the study, which lasts up to 6 months. Researchers will monitor the effects of the treatment through medical assessments, blood tests, side effect checks, and questionnaires. The primary outcome is the percentage of participants aged 6 to 17 years who experience freedom from pain 2 hours after the initial dose. The study includes safety monitoring and evaluates tolerability and pharmacokinetics of ubrogepant in this age group.