Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine

To be considered for this study, you would need to be an adult aged between 18 and 75 years old. You should have a history of migraines, meaning you've been diagnosed with them for at least 12 months. Your migraines should typically cause moderate to severe head pain and occur between 2 and 8 times a month. Your migraine episodes should usually last between 4 and 72 hours if not treated, and you should have at least 48 hours without headache pain between attacks.

There are also some reasons why you might not be able to join. For example, if you typically have 15 or more headache days per month, or if you've been diagnosed with what's called 'chronic migraine', you wouldn't be eligible. Also, if you’ve needed hospital or emergency care for your migraines 3 or more times in the last six months, this study might not be suitable for you.

If you join this study, it's divided into two main parts. Initially, you'll be part of a 'double-blind' phase where you'll be given either the study medicine (atogepant) or a placebo (a dummy tablet) to treat up to 4 of your migraine attacks. Neither you nor your study doctor will know which you're receiving during this phase. You will be told at the start which of four possible sequences you will follow for receiving the medication or placebo. After you've treated 4 migraine attacks, everyone will move into an 'open-label' phase. In this part, both you and your doctors will know you're receiving atogepant, and you'll use it to treat any additional migraines you have until the study ends at 24 weeks.

Taking part involves a commitment to regular check-ups. You'll have visits at a hospital or clinic, as well as some telephone calls with the study team. To help evaluate the treatment, you'll be asked to complete questionnaires using an electronic diary. You'll also have medical check-ups, some blood tests, and the team will carefully monitor you for any side effects.