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



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 75
Updated:1/5/2019
Start Date:July 22, 2016
End Date:December 14, 2017

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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability 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.
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Springfield, Missouri 65807
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
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4720 S. Western Avenue
Oklahoma City, Oklahoma 73109
405-634-5529
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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Albuquerque, New Mexico
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6035 Shallowford Road
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
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10040 Regency Cir
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3100 Duraleigh Rd
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
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