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

Running, not enrolling

Conditions studied: Migraine

In brief

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will evaluate the effectiveness of atogepant in treating adult participants with migraine in a real-world setting. Atogepant is an approved drug for preventive treatment of migraine in adults. Approximately 1000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study across the world. Participants will receive atogepant oral tablets as prescribed per standard clinical practice and will be followed for 2 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Key facts

Study ID

NCT06543914

Run by

AbbVie

People needed

1314

Starts

2024-11-26

Expected to finish

2029-02-01

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Rehabilitation & Neurological Services /ID# 267612 — Huntsville, Alabama, United States
• Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 267610 — Phoenix, Arizona, United States
• Kenneth Martinez MD, A Medical Corp /ID# 267834 — Aliso Viejo, California, United States
• BNL Health - Los Angeles Headache Center /ID# 267570 — Los Angeles, California, United States
• Alcanza Clinical Research, LLC /ID# 267838 — Lake Mary, Florida, United States
• Norton Cancer Institute - St. Matthews /ID# 267605 — Louisville, Kentucky, United States
• Dent Neurologic Institute - Amherst /ID# 267606 — Amherst, New York, United States
• Northwell Health - Great Neck /ID# 280705 — Great Neck, New York, United States
• Northwell Health /ID# 267596 — New York, New York, United States
• Thomas Jefferson University Hospital /ID# 267572 — Philadelphia, Pennsylvania, United States
• Inova Health Care System /ID# 267615 — Falls Church, Virginia, United States
• Neuroscience Group /ID# 267571 — Neenah, Wisconsin, United States
• Cliniques Universitaires UCL Saint-Luc /ID# 270545 — Brussels, Brussels Capital, Belgium
• Universitair Ziekenhuis Brussel /ID# 269799 — Jette, Brussels Capital, Belgium
• Chu Tivoli /ID# 271254 — La Louvière, Hainaut, Belgium
• Centre Hospitalier Régional de la Citadelle /ID# 270539 — Liège, Liege, Belgium
• Groupe Sante CHC - Clinique du MontLegia /ID# 270218 — Liège, Liege, Belgium
• OLV Ziekenhuis Aalst /ID# 270284 — Aalst, Oost-Vlaanderen, Belgium
• Algemeen Ziekenhuis Sint-Jan Brugge /ID# 270540 — Bruges, West-Vlaanderen, Belgium
• AZ Groeninge /ID# 272772 — Kortrijk, West-Vlaanderen, Belgium
• Calgary Headache Assessment and Management Program /ID# 270266 — Calgary, Alberta, Canada
• Burrard Health Center /ID# 270268 — Vancouver, British Columbia, Canada
• Dr. Renju Kuriakose Prof. Corp. /ID# 273178 — Saint John, New Brunswick, Canada
• Maritime Neurology /ID# 270270 — Halifax, Nova Scotia, Canada
• Neurology and Neurodiagnostics of Alabama /ID# 267614 — Hoover, Alabama, United States

Full record on ClinicalTrials.gov

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