Observational Study of Atogepant for Migraine

This study is looking at how well atogepant works for adults with migraine in a real-world setting. Atogepant is an approved oral medication used to prevent migraine headaches. You might be able to join if you are an adult (18 years or older) with at least a one-year history of migraine and your doctor has prescribed atogepant for you. The study will measure how many participants feel "much better" or "very much better" after 12 weeks of treatment. The study status is currently unclear, and it aims to enroll about 1314 participants.

Study design
This is an observational study, meaning researchers will watch how atogepant is used in regular practice. Approximately 1314 adult participants who are prescribed atogepant will be enrolled.
What's involved
You will take atogepant oral tablets as prescribed by your doctor. You will be followed for 2 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 2 years 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.

NCT06543914

Observational Study of Oral Atogepant to Evaluate Real-World Effectiveness in Adult Participants With Migraine

Active, Not Recruiting
Not specifiedAges 18+Observational
AbbVie
~1,314 participants
Updated 2026-06-01 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 112 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Achieving a rating of "much better" or "very much better" as assessed by the Patient Global Impression of Change (PGI-C)
Measured over Week 12
Migraine
112 sites across 70 states
Spain7
Italy5
Ontario4
Germany4
Lisbon District4
New York3
Canton of Zurich3
Taiwan3
  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

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

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Eligibility criteria

Inclusion

At least 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD)-3, 2018.
Prescribed atogepant according to the relevant approved local label.
For participants who initiate atogepant at the prescribing physician or treating health care provider (HCP) discretion as part of their routine clinical care, the decision to administer atogepant must be made prior to and independent of recruitment into the study.
Willing and able to comply with the requirements of the study.
Not on concomitant preventive medication for migraine or have been on a stable preventive medication for migraine for at least 3 months prior to enrollment in the study. If on a stable preventive medication, the prescribing physician or treating HCP and participant must confirm that there is no plan to change concomitant preventive medication during the first 12 weeks of the study.

Exclusion

Previously exposed to atogepant as routine therapy or from clinical trials experience prior to entry.
Contraindications to atogepant as per local labeling.
Pregnant or planning to be pregnant or women of childbearing potential not using contraception.
Enrolled in any interventional studies that may include investigational compounds for migraine, or non-AbbVie observational studies.
In the opinion of the prescribing physician or treating HCP, the participant has a history or current evidence of any condition that might interfere with patient's ability to comply with the study requirements.
  • Percentage of Participants Achieving a rating of "much better" or "very much better" as assessed by the Patient Global Impression of Change (PGI-C)Week 12

    PGI-C is a single item used to measure the patient's impression of overall change in migraine since the first dose of atogepant. The measure uses a 7-point rating scale with responses ranging from "very much better" to "very much worse".