Phase 3 Study of Oral Ubrogepant Tablets for Treating Migraine Attacks in Children and Adolescents Ages 6 to 17

What this Trial Is About

Migraine is a common neurological disorder that causes moderate to severe headache attacks, often with nausea, vomiting, and sensitivity to light and sound. This study is evaluating 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 trial includes two participant groups a pharmacokinetic PK cohort for dose analysis in younger children and a main study cohort involving randomized treatment with different ubrogepant doses or placebo. Participants aged 6 to 11 years in the PK cohort will receive one of two doses of ubrogepant to determine dosing for the main study. In the main study, children aged 6 to 11 and adolescents aged 12 to 17 will be randomly assigned to low or high doses of ubrogepant or placebo, with a one in three chance of receiving placebo. For qualifying migraine attacks, participants will take oral tablets of the assigned study treatment, with the option of a second dose or rescue medication at least two hours later if headaches remain moderate or severe. Participants will be involved for up to six months and will attend regular hospital or clinic visits. Researchers will monitor treatment effects using medical assessments, blood tests, side effect checks, and questionnaires. The primary outcome measured is the percentage of participants achieving pain freedom two hours after the initial dose. Safety, tolerability, and pharmacokinetic data will also be collected to understand ubrogepants effects in this younger population.

Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)