Evaluating the effectiveness of atogepant for migraine treatment in adults

A ProspeCtive ObseRvatioNal Study of Atogepant Effectiveness in Routine Clinical Practice

Observational AbbVie · NCT06543914

This study is testing how well atogepant works for preventing migraines in adults by following about 1000 people over two years as they use the medication in their everyday lives.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Locations111 sites (Hoover, Alabama and 110 other locations)
Trial IDNCT06543914 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the real-world effectiveness of atogepant, an approved medication for migraine prevention, in adult participants. Approximately 1000 adults with a history of migraine will be enrolled globally and prescribed atogepant as part of their routine clinical care. Participants will be monitored over a two-year period, attending regular visits at their healthcare facilities without any additional burdens. The study will gather data on the medication's effectiveness in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates are adults with a history of migraine who have been prescribed atogepant as part of their routine care.

Not a fit: Patients who are currently on other preventive migraine medications or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of atogepant for migraine management in everyday clinical practice.

How similar studies have performed: Other studies have shown positive outcomes with similar approaches in evaluating real-world effectiveness of migraine treatments, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Hoover, Alabama and 110 other locations

+61 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.
Conditions MigraineAtogepantQuliptaAquipta
Last reviewed 2026-06-13 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.