Efficacy, Safety, and Tolerability 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 (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.

Key facts

Study ID

NCT02867709

Run by

Allergan

People needed

1686

Starts

2016-08-26

Expected to finish

2018-02-26

Last updated by the study team

2019-03-19

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 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.

Where it is running

• Clinical Research Advantage, Inc./East Valley Family Physicians, PLC — Chandler, Arizona, United States
• St. Joseph's Hospital & Medical Center - Barrow Neurologic Institute (BNI) — Phoenix, Arizona, United States
• Clinical Research Advantage, Inc./Central Phoenix Medical Clinic, LLC — Phoenix, Arizona, United States
• Mayo Clinic Arizona, May Clinic Scottsdale — Scottsdale, Arizona, United States
• Radiant Research Inc. — Tucson, Arizona, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Axiom Research, LLC — Apple Valley, California, United States
• Hope Clinical Research — Canoga Park, California, United States
• Axiom Research, LLC — Colton, California, United States
• Pharmacology Research Institute — Encino, California, United States
• Neuro-Pain Medical Center — Fresno, California, United States
• California Headache and Balance Center — Fresno, California, United States
• Sun Valley Research Center — Imperial, California, United States
• Grossmont Center For Clinical Research — La Mesa, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• California Advanced Neurotherapeutic, Inc. — Los Angeles, California, United States
• Cedars Sinai Pain Center — Los Angeles, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Rancho Cucamonga Clinical Research — Rancho Cucamonga, California, United States
• Desert Valley Research — Rancho Mirage, California, United States
• George J Rederich MD, Inc — Redondo Beach, California, United States
• Artemis Institute For Clinical Research — San Diego, California, United States
• Clinical Research Advantage, Inc./Cassidy Medical Group-Vista — Vista, California, United States
• Clinicos, LLC — Colorado Springs, Colorado, United States
• Clinical Research Advantage, Inc./Simon Williamson Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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