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

NCT06543914 | Recruiting

• 1 other identifier: P24-880
• Study Type: observational
• Target: 1,000
• Locations: 14 countries
• Sites: 111

Brief 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.

Conditions

Migraine

Keywords

Migraine; Atogepant; Qulipta; Aquipta

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a rating of "much better" or "very much better" as assessed by the Patient Global Impression of Change (PGI-C)

  PGI-C is a single item used to measure the patient's impression of overall change in migraine since the first dose of atogepant. The measure uses a 7-point rating scale with responses ranging from "very much better" to "very much worse".

  Week 12

Study Arms (1)

Atogepant

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with migraine who are prescribed atogepant by their physician per routine standard of care

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (111)

Neurology and Neurodiagnostics of Alabama /ID# 267614

Hoover, Alabama, 35244, United States

COMPLETED

Rehabilitation & Neurological Services /ID# 267612

Huntsville, Alabama, 35805-4046, United States

RECRUITING

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

Phoenix, Arizona, 85013, United States

RECRUITING

Kenneth Martinez MD, A Medical Corp /ID# 267834

Aliso Viejo, California, 92656, United States

RECRUITING

Los Angeles Headache Center /ID# 267570

Los Angeles, California, 90067-2001, United States

RECRUITING

Alcanza Clinical Research, LLC /ID# 267838

Lake Mary, Florida, 32746-2118, United States

RECRUITING

Norton Cancer Institute - St. Matthews /ID# 267605

Louisville, Kentucky, 40207, United States

COMPLETED

Dent Neurologic Institute - Amherst /ID# 267606

Amherst, New York, 14226, United States

RECRUITING

Northwell Health - Great Neck /ID# 280705

Great Neck, New York, 11021, United States

COMPLETED

Northwell Health /ID# 267596

New York, New York, 10022-1304, United States

RECRUITING

Thomas Jefferson University Hospital /ID# 267572

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Inova Health Care System /ID# 267615

Falls Church, Virginia, 22042, United States

RECRUITING

Neuroscience Group /ID# 267571

Neenah, Wisconsin, 54956-1993, United States

RECRUITING

Cliniques Universitaires UCL Saint-Luc /ID# 270545

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

Universitair Ziekenhuis Brussel /ID# 269799

Jette, Brussels Capital, 1090, Belgium

ACTIVE NOT RECRUITING

Chu Tivoli /ID# 271254

La Louvière, Hainaut, 7100, Belgium

RECRUITING

Centre Hospitalier Régional de la Citadelle /ID# 270539

Liège, Liege, 4000, Belgium

RECRUITING

Groupe Sante CHC - Clinique du MontLegia /ID# 270218

Liège, Liege, 4000, Belgium

ACTIVE NOT RECRUITING

OLV Ziekenhuis Aalst /ID# 270284

Aalst, Oost-Vlaanderen, 9300, Belgium

ACTIVE NOT RECRUITING

AZ Sint-Jan Brugge /ID# 270540

Bruges, West-Vlaanderen, 8000, Belgium

ACTIVE NOT RECRUITING

AZ Groeninge /ID# 272772

Kortrijk, West-Vlaanderen, 8500, Belgium

ACTIVE NOT RECRUITING

Calgary Headache Assessment and Management Program /ID# 270266

Calgary, Alberta, T3M 1M4, Canada

RECRUITING

Burrard Health Center /ID# 270268

Vancouver, British Columbia, V6Z 2E8, Canada

RECRUITING

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

Saint John, New Brunswick, E2K 4P8, Canada

RECRUITING

Maritime Neurology /ID# 270270

Halifax, Nova Scotia, B3R 1V9, Canada

RECRUITING

Centricity /ID# 271478

London, Ontario, N6A 2C2, Canada

RECRUITING

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

London, Ontario, N6A 5W9, Canada

RECRUITING

Bayshore Neurology /ID# 270673

Ottawa, Ontario, K2B 8E8, Canada

RECRUITING

Sunnybrook Health Sciences Centre /ID# 273207

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Centre de Recherche St-Louis /ID# 270957

Lévis, Quebec, G6W 0M5, Canada

RECRUITING

Genge Partners /ID# 270267

Montreal, Quebec, H4A 3T2, Canada

RECRUITING

Universitaetsklinikum Heidelberg /ID# 278134

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Universitaetsklinikum Tuebingen /ID# 275762

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

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

Hoppegarten, Brandenburg, 15366, Germany

RECRUITING

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

Bad Homburg, Hesse, 61350, Germany

RECRUITING

Evangelisches Krankenhaus Oldenburg /ID# 275823

Oldenburg, Lower Saxony, 26122, Germany

RECRUITING

Universitaetsmedizin Greifswald /ID# 276678

Greifswald, Mecklenburg-Vorpommern, 17489, Germany

RECRUITING

ZNS Siegen /ID# 275660

Siegen, North Rhine-Westphalia, 57076, Germany

RECRUITING

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

Velbert, North Rhine-Westphalia, 42551, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 275759

Dresden, Saxony, 01307, Germany

RECRUITING

Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 281667

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Schmerzklinik Kiel /ID# 275592

Kiel, Schleswig-Holstein, 24149, Germany

RECRUITING

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275760

Berlin, 10117, Germany

RECRUITING

Schmerzzentrum Berlin /ID# 275819

Berlin, 10435, Germany

RECRUITING

Neurologischen Facharztzentrum Berlin /ID# 275919

Berlin, 10713, Germany

RECRUITING

Städtisches Klinikum Brandenburg /ID# 275725

Brandenburg, 14770, Germany

RECRUITING

IRCCS Ospedale San Raffaele /ID# 273153

Milan, Milano, 20132, Italy

RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 275269

Naples, Napoli, 80138, Italy

RECRUITING

A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274426

Turin, Piedmont, 10126, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274651

Rome, Roma, 00133, Italy

RECRUITING

Sapienza University of Rome /ID# 273506

Rome, Roma, 00161, Italy

RECRUITING

Azienda Ospedaliero Universitaria delle Marche /ID# 273349

Ancona, 60020, Italy

RECRUITING

Policlinico di Bari Ospedale Giovanni XXIII /ID# 275336

Bari, 70126, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Renato Dulbecco /ID# 272696

Catanzaro, 88100, Italy

RECRUITING

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

Pavia, 27100, Italy

RECRUITING

Azienda Sanitaria Universitaria Giuliano Isontina - Trieste /ID# 274413

Trieste, 34128, Italy

RECRUITING

Gelre Ziekenhuis /ID# 272429

Apeldoorn, Gelderland, 7334 DZ, Netherlands

COMPLETED

Maxima Medisch Centrum, Locatie Veldhoven /ID# 270278

Veldhoven, North Brabant, 5504 DB, Netherlands

RECRUITING

Zaans Medisch Centrum /ID# 269603

Zaandam, North Holland, 1502 DV, Netherlands

RECRUITING

Isala, locatie Zwolle /ID# 269602

Zwolle, Overijssel, 8025 AB, Netherlands

RECRUITING

Maasstad Ziekenhuis /ID# 269601

Rotterdam, South Holland, 3079 DZ, Netherlands

RECRUITING

Hodeverket /ID# 271383

Sandnes, Rogaland, 4319, Norway

RECRUITING

Oslo Hodepinesenter AS /ID# 271384

Oslo, 0275, Norway

RECRUITING

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

Guimarães, Braga District, 4835-044, Portugal

RECRUITING

Hospital da Luz /ID# 267002

Lisbon, Lisbon District, 1500-650, Portugal

RECRUITING

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

Loures, Lisbon District, 2674-514, Portugal

RECRUITING

CUF Sintra Hospital /ID# 272394

Sintra, Lisbon District, 2710-204, Portugal

RECRUITING

Campus Neurológico Sénior /ID# 272392

Torres Vedras, Lisbon District, 2560-280, Portugal

RECRUITING

Hospital CUF Coimbra /ID# 272393

Coimbra, 3000-600, Portugal

RECRUITING

Hospital CUF Porto /ID# 272788

Porto, 4100-180, Portugal

RECRUITING

Hospital Regional Universitario de Malaga /ID# 268272

Málaga, Andalusia, 29010, Spain

RECRUITING

Hospital Universitari de Bellvitge /ID# 268224

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Universitario Severo Ochoa /ID# 268249

Leganés, Madrid, 28911, Spain

RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 268246

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Universitario Central de Asturias /ID# 276477

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Universitario Virgen Macarena /ID# 268244

Seville, Sevilla, 41009, Spain

RECRUITING

Hospital Universitario Vall de Hebron /ID# 268222

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario de La Princesa /ID# 268245

Madrid, 28006, Spain

RECRUITING

Hospital Universitario La Paz /ID# 268238

Madrid, 28046, Spain

RECRUITING

Hospital Alvaro Cunqueiro /ID# 268248

Pontevedra, 36312, Spain

RECRUITING

Hospital Universitario Virgen del Rocio /ID# 268223

Seville, 41013, Spain

RECRUITING

Hospital Clinico Universitario de Valladolid /ID# 268225

Valladolid, 47003, Spain

RECRUITING

Hospital Clinico Universitario Lozano Blesa /ID# 268243

Zaragoza, 50009, Spain

RECRUITING

Karolinska Universitetssjukhuset - Huddinge /ID# 265295

Huddinge, Stockholm County, 141 57, Sweden

RECRUITING

Neurology Clinic /ID# 266707

Stockholm, Stockholm County, 114 33, Sweden

RECRUITING

Skaneuro /ID# 265203

Lund, 222 22, Sweden

RECRUITING

NeuroPraxis Birseck /ID# 266140

Reinach, Basel-Landschaft, 4153, Switzerland

RECRUITING

ZURZACH Care /ID# 265697

Bad Zurzach, Canton of Aargau, 5330, Switzerland

RECRUITING

CHUV, Centre hospitalier universitaire vaudois /ID# 266551

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Kopfwehzentrum Hirslanden Zuerich /ID# 265817

Zollikon, Canton of Zurich, 8702, Switzerland

RECRUITING

Neurozentrum Bellevue /ID# 277666

Zurich, Canton of Zurich, 8001, Switzerland

RECRUITING

University Hospital Zurich /ID# 276450

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

DYA Swiss Institut SA /ID# 266891

Lugano, Canton Ticino, 6900, Switzerland

RECRUITING

EOC Ospedale Regionale Lugano /ID# 266887

Lugano, Canton Ticino, 6900, Switzerland

RECRUITING

Hôpital De Sion /ID# 276360

Sion, Valais, 1951, Switzerland

RECRUITING

Inselspital, Universitaetsspital Bern /ID# 265818

Bern, 3010, Switzerland

RECRUITING

Tri-Service General Hospital /ID# 272082

Taipei, 114, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital /ID# 272084

Taoyuan, 333, Taiwan

RECRUITING

Harley Street Medical Centre /ID# 276430

Abu Dhabi, 000000, United Arab Emirates

RECRUITING

American Center of Neurology and Psychiatry /ID# 276429

Abu Dhabi, United Arab Emirates

RECRUITING

Hull Royal Infirmary /ID# 276819

Hull, East Riding Of Yorkshire, HU3 2JZ, United Kingdom

RECRUITING

Western General Hospital - NHS Lothian /ID# 277029

Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom

RECRUITING

Guy's Hospital /ID# 276817

London, Greater London, SE1 9RT, United Kingdom

RECRUITING

King'S College Hospital /ID# 276818

London, Greater London, SE5 9RS, United Kingdom

RECRUITING

Cripps Health Centre /ID# 277474

Nottingham, Nottinghamshire, NG7 2QW, United Kingdom

RECRUITING

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

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Trust /ID# 279417

Leeds, West Yorkshire, LS9 7TF, United Kingdom

RECRUITING

Great Western Hospital /ID# 276693

Swindon, Wiltshire, SN3 6BB, United Kingdom

RECRUITING

Worcestershire Royal Hospital /ID# 276902

Worcester, Worcestershire, WR5 1DD, United Kingdom

RECRUITING

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

Belfast, BT16 1RH, United Kingdom

RECRUITING

University Hospital of Wales /ID# 276822

Cardiff, CF14 4XW, United Kingdom

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Krystal Spenta

CONTACT

krystal.spenta@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

NO (2); BE (8); US (13); NL (5); DE (15); CA (10); IT (10); ES (13); PT (7); CH (10); TW (2); AE (2); GB (11); SE (3)