Home › Trials › NCT06806293

Oral Atogepant for treating menstrual migraines

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

PHASE3 · AbbVie · NCT06806293

This study is testing a new medication called atogepant to see if it can help adults with menstrual migraines feel better compared to a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment430 (estimated)
Ages18 Years and up
SexFemale
SponsorAbbVie (industry)
Locations72 sites (Beijing, Beijing and 71 other locations)
Trial IDNCT06806293 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy, safety, and tolerability of atogepant, an investigational drug, for the prevention of menstrual migraines in adults. Participants will be randomly assigned to receive either atogepant or a placebo, with the aim of assessing how well the medication works compared to no active treatment. The study will track adverse events and changes in disease activity over the course of the trial. Approximately 430 adult participants with a history of menstrual migraines will be enrolled.

Who should consider this trial

Good fit: Ideal candidates are adult women with a history of menstrual migraines who have regular menstrual cycles.

Not a fit: Patients who do not experience menstrual migraines or have irregular menstrual cycles may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency and severity of menstrual migraines for affected patients.

How similar studies have performed: Other studies have shown promise in using similar approaches for migraine prevention, indicating potential for success with this treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* History and eDiary confirmation have regular menstrual cycles within the range of 21 to 35 days in length (Note: menstrual cycle length is calculated as onset of menses until the day before the next onset of menses).
* History of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) for \>= 12 months prior to Visit 1/Screening.
* Migraine onset before age 50 years.
* By history at Visit 1/Screening, participant meets ICHD-3 criteria for pure menstrual migraine with or without aura, or menstrually-related migraine with or without aura, i.e., in at least 2 out of 3 cycles, experiences migraine attacks starting during the PMP (Day -2 to Day +3 relative to menses onset) in the opinion of the investigator.
* Participant records 3 perimenstrual periods (PMP) in the eDiary during the screening period, and in at least 2 of 3 PMPs the participant experiences and records a migraine attack in the eDiary with at least 1 migraine day.

Exclusion Criteria:

* History of an average of 15 or more headache days per month during the 3 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by International Classification of Headache Disorders, 3rd Edition (ICHD-3).
* An average of 15 or more headache days per month recorded in the eDiary during the screening period.
* History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
* Current diagnosis of new persistent daily headache, trigeminal autonomic cephalalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3.
* Required hospital/emergency room treatment for migraine attacks 3 or more times within 6 months prior to Visit 1/Screening.
* Presence of other confounding pain syndromes, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine per investigator judgment.
* Has a condition or situation, which the investigator feels will compromise the safety of the participant or the quality of the data and renders the subject an unsuitable candidate for the study.

Where this trial is running

Beijing, Beijing and 71 other locations

+22 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 →

Conditions: Menstrual Migraine, Atogepant, QULIPTA, AQUIPTA

Last reviewed 2026-05-15 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.