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

Purpose

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.

Condition

  • Migraine

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Atogepant Participants will receive atogepant as prescribed by their physician in routine clinical practice.

Recruiting Locations

Rehabilitation & Neurological Services /ID# 267612
Huntsville 4068590, Alabama 4829764 35805-4046

Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 267610
Phoenix 5308655, Arizona 5551752 85013
Contact:
Site Coordinator
888-762-3805
info@barrowneuro.org

Kenneth Martinez MD, A Medical Corp /ID# 267834
Aliso Viejo 5323163, California 5332921 92656
Contact:
Site Coordinator
949-305-7122

Los Angeles Headache Center /ID# 267570
Los Angeles 5368361, California 5332921 90067-2001
Contact:
Site Coordinator
310-277-9534

Alcanza Clinical Research, LLC /ID# 267838
Lake Mary 4161373, Florida 4155751 32746-2118
Contact:
Site Coordinator
863-940-2087

Dent Neurologic Institute - Amherst /ID# 267606
Amherst 5107129, New York 5128638 14226
Contact:
Site Coordinator
716-250-2000

Northwell Health /ID# 267596
New York 5128581, New York 5128638 10022-1304
Contact:
Site Coordinator
516-233-2634

Thomas Jefferson University Hospital /ID# 267572
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Site Coordinator
215-955-2243

Inova Health Care System /ID# 267615
Falls Church 4758390, Virginia 6254928 22042
Contact:
Site Coordinator
571-472-4200

Neuroscience Group /ID# 267571
Neenah 5264223, Wisconsin 5279468 54956-1993
Contact:
Site Coordinator
920-725-9373

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

Krystal Spenta
krystal.spenta@abbvie.com