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

NCT ID: NCT06543914

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-26

Study Completion Date

2029-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine

Keywords

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Migraine Atogepant Qulipta Aquipta

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Atogepant

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Neurology and Neurodiagnostics of Alabama /ID# 267614

Hoover, Alabama, United States

Site Status COMPLETED

Rehabilitation & Neurological Services /ID# 267612

Huntsville, Alabama, United States

Site Status RECRUITING

Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 267610

Phoenix, Arizona, United States

Site Status RECRUITING

Kenneth Martinez MD, A Medical Corp /ID# 267834

Aliso Viejo, California, United States

Site Status RECRUITING

Los Angeles Headache Center /ID# 267570

Los Angeles, California, United States

Site Status RECRUITING

Alcanza Clinical Research, LLC /ID# 267838

Lake Mary, Florida, United States

Site Status RECRUITING

Norton Cancer Institute - St. Matthews /ID# 267605

Louisville, Kentucky, United States

Site Status COMPLETED

Dent Neurologic Institute - Amherst /ID# 267606

Amherst, New York, United States

Site Status RECRUITING

Grace Forde /ID# 267596

North New Hyde Park, New York, United States

Site Status RECRUITING

Thomas Jefferson University Hospital /ID# 267572

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Inova Health Care System /ID# 267615

Falls Church, Virginia, United States

Site Status RECRUITING

Neuroscience Group /ID# 267571

Neenah, Wisconsin, United States

Site Status RECRUITING

Cliniques Universitaires UCL Saint-Luc /ID# 270545

Brussels, Brussels Capital, Belgium

Site Status RECRUITING

Universitair Ziekenhuis Brussel /ID# 269799

Jette, Brussels Capital, Belgium

Site Status ACTIVE_NOT_RECRUITING

Chu Tivoli /ID# 271254

La Louvière, Hainaut, Belgium

Site Status RECRUITING

Centre Hospitalier Régional de la Citadelle /ID# 270539

Liège, Liege, Belgium

Site Status RECRUITING

Groupe Sante CHC - Clinique du MontLegia /ID# 270218

Liège, Liege, Belgium

Site Status ACTIVE_NOT_RECRUITING

OLV Ziekenhuis Aalst /ID# 270284

Aalst, Oost-Vlaanderen, Belgium

Site Status ACTIVE_NOT_RECRUITING

AZ Sint-Jan Brugge /ID# 270540

Bruges, West-Vlaanderen, Belgium

Site Status ACTIVE_NOT_RECRUITING

AZ Groeninge /ID# 272772

Kortrijk, West-Vlaanderen, Belgium

Site Status ACTIVE_NOT_RECRUITING

Calgary Headache Assessment and Management Program /ID# 270266

Calgary, Alberta, Canada

Site Status RECRUITING

Burrard Health Center /ID# 270268

Vancouver, British Columbia, Canada

Site Status RECRUITING

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

Saint John, New Brunswick, Canada

Site Status RECRUITING

Maritime Neurology /ID# 270270

Halifax, Nova Scotia, Canada

Site Status RECRUITING

Centricity /ID# 271478

London, Ontario, Canada

Site Status RECRUITING

London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270943

London, Ontario, Canada

Site Status RECRUITING

Bayshore Neurology /ID# 270673

Ottawa, Ontario, Canada

Site Status RECRUITING

Sunnybrook Health Sciences Centre /ID# 273207

Toronto, Ontario, Canada

Site Status RECRUITING

Centre de Recherche St-Louis /ID# 270957

Lévis, Quebec, Canada

Site Status RECRUITING

Genge Partners /ID# 270267

Montreal, Quebec, Canada

Site Status RECRUITING

Universitaetsklinikum Heidelberg /ID# 278134

Heidelberg, Baden-Wurttemberg, Germany

Site Status RECRUITING

Universitaetsklinikum Tuebingen /ID# 275762

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

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

Hoppegarten, Brandenburg, Germany

Site Status RECRUITING

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

Bad Homburg, Hesse, Germany

Site Status RECRUITING

Evangelisches Krankenhaus Oldenburg /ID# 275823

Oldenburg, Lower Saxony, Germany

Site Status RECRUITING

Universitaetsmedizin Greifswald /ID# 276678

Greifswald, Mecklenburg-Vorpommern, Germany

Site Status RECRUITING

ZNS Siegen /ID# 275660

Siegen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Dres. Huhn-Doll/Siquet/Vocke /ID# 279583

Velbert, North Rhine-Westphalia, Germany

Site Status RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 275759

Dresden, Saxony, Germany

Site Status RECRUITING

Schmerzklinik Kiel /ID# 275592

Kiel, Schleswig-Holstein, Germany

Site Status RECRUITING

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275760

Berlin, , Germany

Site Status RECRUITING

Schmerzzentrum Berlin /ID# 275819

Berlin, , Germany

Site Status RECRUITING

Neurologischen Facharztzentrum Berlin /ID# 275919

Berlin, , Germany

Site Status RECRUITING

Städtisches Klinikum Brandenburg /ID# 275725

Brandenburg, , Germany

Site Status RECRUITING

IRCCS Ospedale San Raffaele /ID# 273153

Milan, Milano, Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 275269

Naples, Napoli, Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274651

Rome, Roma, Italy

Site Status RECRUITING

Sapienza University of Rome /ID# 273506

Rome, Roma, Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria delle Marche /ID# 273349

Ancona, , Italy

Site Status RECRUITING

Policlinico di Bari Ospedale Giovanni XXIII /ID# 275336

Bari, , Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria Renato Dulbecco /ID# 272696

Catanzaro, , Italy

Site Status RECRUITING

Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 273155

Pavia, , Italy

Site Status RECRUITING

Azienda Sanitaria Universitaria Giuliano Isontina - Trieste /ID# 274413

Trieste, , Italy

Site Status RECRUITING

Gelre Ziekenhuis /ID# 272429

Apeldoorn, Gelderland, Netherlands

Site Status COMPLETED

Maxima Medisch Centrum, Locatie Veldhoven /ID# 270278

Veldhoven, North Brabant, Netherlands

Site Status RECRUITING

Zaans Medisch Centrum /ID# 269603

Zaandam, North Holland, Netherlands

Site Status RECRUITING

Isala, locatie Zwolle /ID# 269602

Zwolle, Overijssel, Netherlands

Site Status RECRUITING

Maasstad Ziekenhuis /ID# 269601

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Hodeverket /ID# 271383

Sandnes, Rogaland, Norway

Site Status RECRUITING

Oslo Hodepinesenter AS /ID# 271384

Oslo, , Norway

Site Status RECRUITING

Unidade Local de Saude do Alto Ave, EPE /ID# 274767

Guimarães, Braga District, Portugal

Site Status RECRUITING

Hospital da Luz /ID# 267002

Lisbon, Lisbon District, Portugal

Site Status RECRUITING

Unidade Local de Saude de Loures-Odivelas, EPE /ID# 274764

Loures, Lisbon District, Portugal

Site Status RECRUITING

CUF Sintra Hospital /ID# 272394

Sintra, Lisbon District, Portugal

Site Status RECRUITING

Campus Neurológico Sénior /ID# 272392

Torres Vedras, Lisbon District, Portugal

Site Status RECRUITING

Hospital CUF Coimbra /ID# 272393

Coimbra, , Portugal

Site Status RECRUITING

Hospital CUF Porto /ID# 272788

Porto, , Portugal

Site Status RECRUITING

Hospital Regional Universitario de Malaga /ID# 268272

Málaga, Andalusia, Spain

Site Status RECRUITING

Hospital Universitari de Bellvitge /ID# 268224

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Hospital Universitario Severo Ochoa /ID# 268249

Leganés, Madrid, Spain

Site Status RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 268246

Majadahonda, Madrid, Spain

Site Status RECRUITING

Hospital Universitario Central de Asturias /ID# 276477

Oviedo, Principality of Asturias, Spain

Site Status RECRUITING

Hospital Universitario Virgen Macarena /ID# 268244

Seville, Sevilla, Spain

Site Status RECRUITING

Hospital Universitario Vall de Hebron /ID# 268222

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario de La Princesa /ID# 268245

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz /ID# 268238

Madrid, , Spain

Site Status RECRUITING

Hospital Alvaro Cunqueiro /ID# 268248

Pontevedra, , Spain

Site Status RECRUITING

Hospital Universitario Virgen del Rocio /ID# 268223

Seville, , Spain

Site Status RECRUITING

Hospital Clinico Universitario de Valladolid /ID# 268225

Valladolid, , Spain

Site Status RECRUITING

Hospital Clinico Universitario Lozano Blesa /ID# 268243

Zaragoza, , Spain

Site Status RECRUITING

Karolinska Universitetssjukhuset - Huddinge /ID# 265295

Huddinge, Stockholm County, Sweden

Site Status RECRUITING

Neurology Clinic /ID# 266707

Stockholm, Stockholm County, Sweden

Site Status RECRUITING

Skaneuro /ID# 265203

Lund, , Sweden

Site Status RECRUITING

NeuroPraxis Birseck /ID# 266140

Reinach, Basel-Landschaft, Switzerland

Site Status RECRUITING

ZURZACH Care /ID# 265697

Bad Zurzach, Canton of Aargau, Switzerland

Site Status RECRUITING

CHUV, Centre hospitalier universitaire vaudois /ID# 266551

Lausanne, Canton of Vaud, Switzerland

Site Status RECRUITING

Kopfwehzentrum Hirslanden Zuerich /ID# 265817

Zollikon, Canton of Zurich, Switzerland

Site Status RECRUITING

Neurozentrum Bellevue /ID# 277666

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

University Hospital Zurich /ID# 276450

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

DYA Swiss Institut SA /ID# 266891

Lugano, Canton Ticino, Switzerland

Site Status RECRUITING

EOC Ospedale Regionale Lugano /ID# 266887

Lugano, Canton Ticino, Switzerland

Site Status RECRUITING

Hôpital De Sion /ID# 276360

Sion, Valais, Switzerland

Site Status RECRUITING

Inselspital, Universitaetsspital Bern /ID# 265818

Bern, , Switzerland

Site Status RECRUITING

Tri-Service General Hospital /ID# 272082

Taipei, , Taiwan

Site Status RECRUITING

Linkou Chang Gung Memorial Hospital /ID# 272084

Taoyuan, , Taiwan

Site Status RECRUITING

American Center of Neurology and Psychiatry /ID# 276429

Abu Dhabi, , United Arab Emirates

Site Status RECRUITING

Hull Royal Infirmary /ID# 276819

Hull, East Riding Of Yorkshire, United Kingdom

Site Status RECRUITING

Western General Hospital - NHS Lothian /ID# 277029

Edinburgh, Edinburgh, City of, United Kingdom

Site Status RECRUITING

Guy's Hospital /ID# 276817

London, Greater London, United Kingdom

Site Status RECRUITING

King'S College Hospital /ID# 276818

London, Greater London, United Kingdom

Site Status RECRUITING

Cripps Health Centre /ID# 277474

Nottingham, Nottinghamshire, United Kingdom

Site Status RECRUITING

University Hospitals North Midlands - Royal Stoke University Hospital /ID# 276821

Stoke-on-Trent, Staffordshire, United Kingdom

Site Status RECRUITING

Leeds Teaching Hospitals NHS Trust /ID# 279417

Leeds, West Yorkshire, United Kingdom

Site Status RECRUITING

Great Western Hospital /ID# 276693

Swindon, Wiltshire, United Kingdom

Site Status RECRUITING

Worcestershire Royal Hospital /ID# 276902

Worcester, Worcestershire, United Kingdom

Site Status RECRUITING

Ulster Hospital - South Eastern Health & Social Care Trust /ID# 276900

Belfast, , United Kingdom

Site Status RECRUITING

University Hospital of Wales /ID# 276822

Cardiff, , United Kingdom

Site Status RECRUITING

Countries

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United States Belgium Canada Germany Italy Netherlands Norway Portugal Spain Sweden Switzerland Taiwan United Arab Emirates United Kingdom

Central Contacts

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Krystal Spenta

Role: CONTACT

Email: [email protected]

Facility Contacts

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Site Coordinator

Role: primary

Site Coordinator

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Site Coordinator

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Site Coordinator

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Site Coordinator

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Site Coordinator

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Site Coordinator

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Site Coordinator

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Site Coordinator

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Site Coordinator

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Site Coordinator

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Site Coordinator

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Related Links

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Other Identifiers

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P24-880

Identifier Type: -

Identifier Source: org_study_id