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Evaluating Ubrogepant for Treating Menstrual Migraine

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension

Phase 3 Interventional AbbVie · NCT06417775

This study is testing if a new medication called ubrogepant can help women with menstrual migraines feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment496 (estimated)
Ages18 Years and up
SexFemale
SponsorAbbVie Industry-sponsored
Locations106 sites (Birmingham, Alabama and 105 other locations)
Trial IDNCT06417775 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of ubrogepant, an investigational drug, in treating menstrual migraine in adult women. Participants will be randomly assigned to receive either ubrogepant or a placebo, with the study aiming to enroll around 450 women across approximately 100 sites in the United States and Puerto Rico. The trial will assess adverse events and changes in disease activity through daily eDiary data collection over a screening period of up to 16 weeks.

Who should consider this trial

Good fit: Ideal candidates are adult women with a history of menstrual migraines who experience migraine attacks during their perimenstrual periods.

Not a fit: Patients with specific types of migraines, such as those with brainstem aura or hemiplegic migraine, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for women suffering from menstrual migraines.

How similar studies have performed: Other studies have shown promising results with similar approaches to treating migraines, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 105 other locations

+56 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MigraineMenstrual MigraineUbrogepantUBRELVY
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.