Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine
Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine
This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50
 and 100 mg) compared to placebo for the acute treatment of a single migraine attack.
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 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, diarrhea 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.