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Study of Ubrogepant for Menstrual Migraine

This study is looking at how safe and effective an oral tablet called ubrogepant is for treating menstrual migraine. Menstrual migraine (MM) refers to migraine attacks that happen around your period. You might be eligible if you are an adult woman, 18 years or older, with a history of migraine for at least one year, and have experienced migraines during your perimenstrual periods (PMPs) in at least two of the last three cycles. To join, you'll need to track your daily symptoms for up to 16 weeks to confirm your menstrual migraine diagnosis. The study will measure changes in the number of migraine days during your PMPs and track any side effects. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 496 adult women. Participants will receive either ubrogepant or a placebo (an inactive substance).
What's involved
You will need to collect daily eDiary data for three perimenstrual periods during an up to 16-week screening period. The study will then involve a double-blind treatment period lasting up to approximately 16 weeks, followed by safety monitoring for up to approximately 68 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 68 weeks after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06417775

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

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
AbbVie
~496 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:UbrogepantPlacebo for Ubrogepant

At a glance

Recruiting sites
0 of 106 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period
Measured over Up to approximately 16 Weeks
+1 more outcome measured

Conditions

Migraine

Explore related trials

Menstrual migraineMigraine

Where it's being run

106 sites across 40 states
California12
Texas9
Florida8
New York6
Utah5
Arizona4
Ohio4
Kansas3

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment PeriodUp to approximately 16 Weeks

    A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.

  • Number of Participants With Adverse Events (AEs)Up to approximately 68 Weeks

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.