Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Migraine

In brief

A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed. Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 496 adult female participants with menstrual migraine will be enrolled in approximately 100 sites in the United States and Puerto Rico. Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key facts

Study ID

NCT06417775

Run by

AbbVie

People needed

496

Starts

2024-09-10

Expected to finish

2027-09-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rehabilitation and Neurological Services /ID# 275593 — Huntsville, Alabama, United States
• MD First Research - Chandler /ID# 262564 — Chandler, Arizona, United States
• Gilbert Neurology /ID# 260179 — Gilbert, Arizona, United States
• Foothills Research Center/CCT Research /ID# 260180 — Phoenix, Arizona, United States
• Trialmed-Synexus Clinical Research US, Inc. - Tucson /ID# 258309 — Tucson, Arizona, United States
• Preferred Research Partners /ID# 262786 — Little Rock, Arkansas, United States
• Preferred Research Partners /ID# 273128 — Little Rock, Arkansas, United States
• Hope Clinical Research /ID# 257867 — Canoga Park, California, United States
• Axiom Research /ID# 257833 — Colton, California, United States
• Neuro Pain Research Center /ID# 257155 — Fresno, California, United States
• Axiom Research, LLC-Los Angeles /ID# 264085 — Glendale, California, United States
• Sun Valley Research Center /ID# 257152 — Imperial, California, United States
• Axiom Research - Irvine /ID# 264083 — Irvine, California, United States
• CenExel Collaborative Neuroscience Research /ID# 257828 — Los Alamitos, California, United States
• BNL Health - Los Angeles Headache Center /ID# 257237 — Los Angeles, California, United States
• M3 Wake Research - Newport Beach /ID# 257158 — Newport Beach, California, United States
• Artemis Institute for Clinical Research - San Diego /ID# 257134 — San Diego, California, United States
• M3 Wake Research - Convoy /ID# 257897 — San Diego, California, United States
• Optimus Medical /ID# 257856 — San Francisco, California, United States
• New England Institute for Clinical Research /ID# 264019 — Stamford, Connecticut, United States
• Neurology Offices of South Florida, PLLC /ID# 257161 — Boca Raton, Florida, United States
• Accel Research Sites Network - DeLand Clinical Research Unit /ID# 257403 — DeLand, Florida, United States
• Accel Research Sites - Lakeland Clinical Research Unit /ID# 257874 — Lakeland, Florida, United States
• Well Pharma Medical Research /ID# 257199 — Miami, Florida, United States
• Central Research Associates /ID# 260161 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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