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

Last updated: April 7, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain (Pediatric)

Chronic Pain

Headaches

Treatment

N/A

Clinical Study ID

NCT06543914
P24-880
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 1-year history of migraine with or without aura consistent with a diagnosisaccording 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 treatinghealth care provider (HCP) discretion as part of their routine clinical care, thedecision to administer atogepant must be made prior to and independent ofrecruitment 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 stablepreventive medication for migraine for at least 3 months prior to enrollment in thestudy. If on a stable preventive medication, the prescribing physician or treatingHCP and participant must confirm that there is no plan to change concomitantpreventive medication during the first 12 weeks of the study.

Exclusion

Exclusion Criteria:

  • Previously exposed to atogepant as routine therapy or from clinical trialsexperience prior to entry.

  • Contraindications to atogepant as per local labeling.

  • Pregnant or planning to be pregnant or women of childbearing potential not usingcontraception.

  • Enrolled in any interventional studies that may include investigational compoundsfor migraine, or non-AbbVie observational studies.

  • In the opinion of the prescribing physician or treating HCP, the participant has ahistory or current evidence of any condition that might interfere with patient'sability to comply with the study requirements.

Study Design

Total Participants: 1000
Study Start date:
November 26, 2024
Estimated Completion Date:
February 28, 2029

Connect with a study center

  • Universitair Ziekenhuis Brussel /ID# 269799

    Jette, Bruxelles-Capitale 1090
    Belgium

    Active - Recruiting

  • Chu Tivoli /ID# 271254

    La Louvière, Hainaut 7100
    Belgium

    Active - Recruiting

  • Centre Hospitalier Régional de la Citadelle /ID# 270539

    Liège, Liege 4000
    Belgium

    Active - Recruiting

  • Onze Lieve Vrouw Ziekenhuis Aalst /ID# 270284

    Aalst, Oost-Vlaanderen 9300
    Belgium

    Active - Recruiting

  • AZ Groeninge /ID# 272772

    Kortrijk, West-Vlaanderen 8500
    Belgium

    Active - Recruiting

  • AZ Sint-Jan Brugge /ID# 270540

    Brugge, 8000
    Belgium

    Active - Recruiting

  • Groupe Sante CHC - Clinique du MontLegia /ID# 270218

    Liege, 4000
    Belgium

    Active - Recruiting

  • Burrard Health Center /ID# 270268

    Vancouver, British Columbia V6Z 2E8
    Canada

    Active - Recruiting

  • Dr. Renju Kuriakose Prof. Corp. /ID# 273178

    Saint John, New Brunswick E2K 4P8
    Canada

    Active - Recruiting

  • Maritime Neurology /ID# 270270

    Halifax, Nova Scotia B3R 1V9
    Canada

    Active - Recruiting

  • Centricity /ID# 271478

    London, Ontario N6A 2C2
    Canada

    Active - Recruiting

  • Bayshore Neurology /ID# 270673

    Ottawa, Ontario K2B 8E8
    Canada

    Active - Recruiting

  • Centre de Recherche St-Louis /ID# 270957

    Lévis, Quebec G6W 0M5
    Canada

    Active - Recruiting

  • Genge Partners /ID# 270267

    Montreal, Quebec H4A 3T2
    Canada

    Active - Recruiting

  • Praxis fur Neurologie Dr. med. Martin Delf /ID# 275918

    Hoppegarten, Brandenburg 15366
    Germany

    Active - Recruiting

  • Zentrum Für Klinische Forschung Dr. Irma Schöll /ID# 275642

    Bad Homburg, Hessen 61350
    Germany

    Active - Recruiting

  • ZNS Siegen /ID# 275660

    Siegen, Nordrhein-Westfalen 57076
    Germany

    Active - Recruiting

  • Schmerzklinik Kiel /ID# 275592

    Kiel, Schleswig-Holstein 24149
    Germany

    Active - Recruiting

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275760

    Berlin, 10117
    Germany

    Active - Recruiting

  • Neurologischen Facharztzentrum Berlin /ID# 275919

    Berlin, 10713
    Germany

    Active - Recruiting

  • Schmerzzentrum Berlin /ID# 275819

    Berlin, 10435
    Germany

    Active - Recruiting

  • Städtisches Klinikum Brandenburg /ID# 275725

    Brandenburg, 14770
    Germany

    Active - Recruiting

  • Gelre Ziekenhuis /ID# 272429

    Apeldoorn, Gelderland 7334 DZ
    Netherlands

    Active - Recruiting

  • Isala, locatie Zwolle /ID# 269602

    Zwolle, Overijssel 8025 AB
    Netherlands

    Active - Recruiting

  • Hospital da Luz /ID# 267002

    Lisbon, Lisboa 1500-650
    Portugal

    Active - Recruiting

  • Campus Neurológico Sénior /ID# 272392

    Torres Vedras, Lisboa 2560-280
    Portugal

    Active - Recruiting

  • Hospital CUF Porto /ID# 272788

    Porto, 4100-180
    Portugal

    Active - Recruiting

  • Hospital Regional Universitario de Malaga /ID# 268272

    Malaga, Andalucia 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Severo Ochoa /ID# 268249

    Leganés, Madrid 28911
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 268246

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena /ID# 268244

    Seville, Sevilla 41009
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz /ID# 268238

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario de La Princesa /ID# 268245

    Madrid, 28006
    Spain

    Active - Recruiting

  • Duplicate_Hospital Universitario Virgen del Rocio /ID# 268223

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio /ID# 268223

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valladolid /ID# 268225

    Valladolid, 47003
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Lozano Blesa /ID# 268243

    Zaragoza, 50009
    Spain

    Active - Recruiting

  • Neurology and Neurodiagnostics of Alabama /ID# 267614

    Hoover, Alabama 35244
    United States

    Active - Recruiting

  • Kenneth Martinez MD, A Medical Corp /ID# 267834

    Aliso Viejo, California 92656
    United States

    Active - Recruiting

  • Los Angeles Headache Center /ID# 267570

    Los Angeles, California 90067-2001
    United States

    Active - Recruiting

  • Alcanza Clinical Research, LLC /ID# 267838

    Lake Mary, Florida 32746-2118
    United States

    Active - Recruiting

  • Norton Healthcare /ID# 267605

    Louisville, Kentucky 40207-4700
    United States

    Active - Recruiting

  • Dent Neurologic Group, Llp /Id# 267606

    Amherst, New York 14226-1723
    United States

    Active - Recruiting

  • Dent Neurologic Institute - Amherst /ID# 267606

    Amherst, New York 14226
    United States

    Active - Recruiting

  • Grace Forde /ID# 267596

    N. New Hyde Park, New York 11042-2040
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital /ID# 267572

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Inova Health Care System /ID# 267615

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

  • Neuroscience Group /ID# 267571

    Neenah, Wisconsin 54956-1993
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.