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

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine, With or Without Aura

In brief

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.

Key facts

Study ID

NCT02828020

Run by

Allergan

People needed

1672

Starts

2016-07-22

Expected to finish

2017-12-14

Last updated by the study team

2019-01-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Xenoscience, Inc. — Phoenix, Arizona, United States
• Clinical Research Advantage, Inc./Orange Grove Family Practice — Tucson, Arizona, United States
• Principals Research Group, Inc. — Hot Springs, Arkansas, United States
• KLR Business Group, Inc. dba Arkansas Clinical Research — Little Rock, Arkansas, United States
• The Research Center of Southern California, LLC — Carlsbad, California, United States
• Med Center — Carmichael, California, United States
• T. Joseph Raoof MD, Inc./Encino Research Center — Encino, California, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• Prime Care Clinical Research — Laguna Hills, California, United States
• Collaborative Neuroscience Network, LLC. — Long Beach, California, United States
• Synergy San Diego — National City, California, United States
• Newport Beach Clinical Research Associates, Inc. — Newport Beach, California, United States
• North County Clinical Research — Oceanside, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• CA Medical Clinic for Headache — Santa Monica, California, United States
• Southern California Research LLC — Simi Valley, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Alpine Clinical Research Center, Inc. — Boulder, Colorado, United States
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
• Delta Waves, Inc — Colorado Springs, Colorado, United States
• Denver Neurological Research — Denver, Colorado, United States
• Associated Neurologists, P.C. — Danbury, Connecticut, United States
• Associated Neurolgists of Southern Connecticut, PC — Fairfield, Connecticut, United States
• Clinical Research Advantage, Inc./Desert Clinical Research, LLC. — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.