Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine
Launched by ALLERGAN · Jul 7, 2016
Trial Information
Current as of April 24, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- 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.
Trial Officials
Adele Thorpe
Study Director
Allergan
About Allergan
Allergan, a global leader in pharmaceutical innovation, specializes in developing and commercializing a diverse portfolio of advanced therapeutic and aesthetic products. With a commitment to improving the health and well-being of patients, Allergan conducts rigorous clinical trials to evaluate the safety and efficacy of its therapies across various medical fields, including ophthalmology, dermatology, and neuroscience. The company is dedicated to adhering to the highest ethical standards and regulatory guidelines, ensuring that its research not only advances medical science but also meets the needs of healthcare providers and patients worldwide. Through strategic collaborations and a focus on scientific excellence, Allergan continues to drive advancements in treatment options and enhance patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tampa, Florida, United States
Rochester, New York, United States
Manlius, New York, United States
Raleigh, North Carolina, United States
Kingsport, Tennessee, United States
Oklahoma City, Oklahoma, United States
Ann Arbor, Michigan, United States
Gainesville, Florida, United States
Baltimore, Maryland, United States
Portland, Oregon, United States
Memphis, Tennessee, United States
San Diego, California, United States
Spring Valley, California, United States
Bardstown, Kentucky, United States
Philadelphia, Pennsylvania, United States
Olive Branch, Mississippi, United States
Endwell, New York, United States
Austin, Texas, United States
Stockbridge, Georgia, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
Lyndhurst, Ohio, United States
Minneapolis, Minnesota, United States
Salt Lake City, Utah, United States
Virginia Beach, Virginia, United States
Danbury, Connecticut, United States
Albuquerque, New Mexico, United States
Carmichael, California, United States
Fullerton, California, United States
Salt Lake City, Utah, United States
Kalamazoo, Michigan, United States
Phoenix, Arizona, United States
Bellevue, Washington, United States
Watertown, Massachusetts, United States
Austin, Texas, United States
Colorado Springs, Colorado, United States
Dallas, Texas, United States
Canton, Ohio, United States
Newport Beach, California, United States
Glendale, California, United States
Boston, Massachusetts, United States
Jacksonville, Florida, United States
Oceanside, California, United States
Colorado Springs, Colorado, United States
Columbus, Georgia, United States
Orlando, Florida, United States
Tampa, Florida, United States
San Antonio, Texas, United States
Oklahoma City, Oklahoma, United States
Santa Monica, California, United States
Chicago, Illinois, United States
Chattanooga, Tennessee, United States
Springfield, Missouri, United States
Long Beach, California, United States
National City, California, United States
Winston Salem, North Carolina, United States
Cincinnati, Ohio, United States
Simi Valley, California, United States
Riverton, Utah, United States
Lenexa, Kansas, United States
Carlsbad, California, United States
Encino, California, United States
Spring Hill, Florida, United States
Mesa, Arizona, United States
Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
Laguna Hills, California, United States
Boulder, Colorado, United States
Denver, Colorado, United States
Fairfield, Connecticut, United States
Hallandale Beach, Florida, United States
Hollywood, Florida, United States
Palm Beach Gardens, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Newburgh, Indiana, United States
Overland Park, Kansas, United States
Overland Park, Kansas, United States
South Dartmouth, Massachusetts, United States
Las Vegas, Nevada, United States
Hickory, North Carolina, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Lincoln, Rhode Island, United States
Lake Jackson, Texas, United States
San Antonio, Texas, United States
Draper, Utah, United States
Seattle, Washington, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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