Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Launched by ABBVIE · May 13, 2024
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called ubrogepant to see if it is safe and effective for treating menstrual migraines in adult women. A menstrual migraine is a severe headache that occurs around the time of a woman's period, specifically within a few days before and after menstruation. The trial aims to find out how well ubrogepant can help reduce the frequency and severity of these headaches. About 450 women who have experienced menstrual migraines regularly will participate in the study, which will take place at around 85 locations across the United States and Puerto Rico.
To be eligible for the trial, participants should have a history of migraines for at least a year and have had menstrual migraines during at least two of their last three menstrual cycles. They should also have regular menstrual cycles and experience fewer than 15 headache days each month. If chosen to participate, women will take ubrogepant or a placebo (a pill with no active medication) for seven days, starting three days before their period. They will keep track of their symptoms daily through electronic diaries and will attend regular check-ups for medical assessments and blood tests. This study may require more commitment than their usual migraine treatment, but it offers a chance to help researchers understand how well ubrogepant works for menstrual migraines.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • At least a 1-year history of migraine with or without aura.
- • Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period.
- • Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period to confirm a menstrual migraine (MM) diagnosis.
- • Have regular menstrual cycles of between 21-35 days in length.
- • Less than 15 headache days per month.
- • At least 70% compliance completing screening period and at least 3 out of 5 days of ediary data in each of 3 screening PMP.
- Exclusion Criteria:
- • History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine.
- • Clinically significant history of cardiovascular or cerebrovascular disease per the investigator's opinion.
- • Clinically significant abnormalities in the physical examination as determined by the investigator.
- • Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecological, or neurologic disease per the investigator's opinion.
- • Acute headache medication overuse.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tucson, Arizona, United States
Fresno, California, United States
Ocoee, Florida, United States
Orlando, Florida, United States
Winter Park, Florida, United States
Stockbridge, Georgia, United States
Baltimore, Maryland, United States
Springfield, Missouri, United States
Fargo, North Dakota, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Los Angeles, California, United States
San Diego, California, United States
Boca Raton, Florida, United States
Newton, Kansas, United States
Wichita, Kansas, United States
Deland, Florida, United States
Lakeland, Florida, United States
Albuquerque, New Mexico, United States
Hartsdale, New York, United States
Columbus, Ohio, United States
Knoxville, Tennessee, United States
Charlottesville, Virginia, United States
Tacoma, Washington, United States
New Bedford, Massachusetts, United States
Birmingham, Alabama, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Canoga Park, California, United States
Colton, California, United States
Los Alamitos, California, United States
Newport Beach, California, United States
San Francisco, California, United States
Miami, Florida, United States
Ames, Iowa, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Monroe, Louisiana, United States
Boston, Massachusetts, United States
Papillion, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Toms River, New Jersey, United States
Warren, New Jersey, United States
Amherst, New York, United States
New York, New York, United States
Williamsville, New York, United States
Greensboro, North Carolina, United States
Raleigh, North Carolina, United States
Winston Salem, North Carolina, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Abington, Pennsylvania, United States
Greer, South Carolina, United States
North Charleston, South Carolina, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Bellevue, Washington, United States
San Diego, California, United States
Irvine, California, United States
Ann Arbor, Michigan, United States
Cumberland, Rhode Island, United States
Marrero, Louisiana, United States
Dallas, Texas, United States
Flossmoor, Illinois, United States
Imperial, California, United States
Chandler, Arizona, United States
Evansville, Indiana, United States
Hazelwood, Missouri, United States
Morgantown, West Virginia, United States
Waltham, Massachusetts, United States
Fremont, Nebraska, United States
Lake Jackson, Texas, United States
Little Rock, Arkansas, United States
Meridian, Idaho, United States
New York, New York, United States
Guaynabo, , Puerto Rico
Beckley, West Virginia, United States
Stamford, Connecticut, United States
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Portland, Oregon, United States
Lampasas, Texas, United States
Amherst, New York, United States
Greenville, South Carolina, United States
Glendale, California, United States
Marrero, Louisiana, United States
Winston Salem, North Carolina, United States
Waxahachie, Texas, United States
Lewisville, Texas, United States
Houston, Texas, United States
Little Rock, Arkansas, United States
Seabrook, Texas, United States
Cleveland, Ohio, United States
Ridgeland, Mississippi, United States
Honolulu, Hawaii, United States
Tucson, Arizona, United States
Cumberland, Rhode Island, United States
Fresno, California, United States
Mequon, Wisconsin, United States
Gilbert, Arizona, United States
Franklin, Tennessee, United States
Atlanta, Georgia, United States
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported