Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

Inclusion Criteria:

- At least a 1-year history of migraine with or without aura consistent with a diagnosis
according to the International Classification of Headache Disorders, 3rd edition, beta
version

- Migraine onset before age 50

- History of migraines typically lasting between 4 and 72 hours if untreated or treated
unsuccessfully and migraine episodes are separated by at least 48 hours of headache
pain freedom

- History of 2 to 8 migraine attacks per month with moderate to severe headache pain in
each of the previous 3 months.

Exclusion Criteria:

- Difficulty distinguishing migraine headache from tension-type other headaches

- Has taken medication for acute treatment of headache (including acetaminophen,
nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergotamine, opioids, or
combination analgesics) on 10 or more days per month in the previous 3 months

- Has a history of migraine aura with diplopia or impairment of level of consciousness,
hemiplegic migraine, or retinal migraine

- Has a current diagnosis of new persistent daily headache, trigeminal autonomic
cephalgia (eg, cluster headache), or painful cranial neuropathy

- Required hospital treatment of a migraine attack 3 or more times in the previous 6
months

- Has a chronic non-headache pain condition requiring daily pain medication

- Has a history of malignancy in the prior 5 years, except for adequately treated basal
cell or squamous cell skin cancer, or in situ cervical cancer

- Has a history of any prior gastrointestinal conditions (eg, diarrhoea syndromes,
inflammatory bowel disease) that may affect the absorption or metabolism of
investigational product; participants with prior gastric bariatric interventions which
have been reversed are not excluded

- Has a history of hepatitis within previous 6 months.