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Search / Trial NCT06417775

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 22, 2025

Recruiting

Keywords

Migraine Menstrual Migraine Ubrogepant Ubrelvy

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.

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

0 patients applied

Trial Officials

ABBVIE INC.

Study Director

AbbVie

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported