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MigraineCORNERSTONENCT06543914

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

An observational study of Migraine, run by AbbVie at 112 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine
How many people
1,314 participants
Where
112 sitesin 14 countries
Study dates
26 Nov 2024to Feb 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

112 sites in 14 countries.

112 sites in 14 countries

Germany15 sites

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

    Bad Homburg, Hesse, 61350

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275760

    Berlin, 10117

  • Schmerzzentrum Berlin /ID# 275819

    Berlin, 10435

  • Neurologischen Facharztzentrum Berlin /ID# 275919

    Berlin, 10713

  • Städtisches Klinikum Brandenburg /ID# 275725

    Brandenburg, 14770

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 275759

    Dresden, Saxony, 01307

  • Universitaetsmedizin Greifswald /ID# 276678

    Greifswald, Mecklenburg-Vorpommern, 17489

  • Universitaetsklinikum Heidelberg /ID# 278134

    Heidelberg, Baden-Wurttemberg, 69120

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

    Hoppegarten, Brandenburg, 15366

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 281667

    Kiel, Schleswig-Holstein, 24105

  • Schmerzklinik Kiel /ID# 275592

    Kiel, Schleswig-Holstein, 24149

  • Evangelisches Krankenhaus Oldenburg /ID# 275823

    Oldenburg, Lower Saxony, 26122

  • ZNS Siegen /ID# 275660

    Siegen, North Rhine-Westphalia, 57076

  • Universitaetsklinikum Tuebingen /ID# 275762

    Tübingen, Baden-Wurttemberg, 72076

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

    Velbert, North Rhine-Westphalia, 42551

Other trials in Germany

United States13 sites

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

    Aliso Viejo, California, 92656

  • Dent Neurologic Institute - Amherst /ID# 267606

    Amherst, New York, 14226

  • Inova Health Care System /ID# 267615

    Falls Church, Virginia, 22042

  • Northwell Health - Great Neck /ID# 280705

    Great Neck, New York, 11021

  • Neurology and Neurodiagnostics of Alabama /ID# 267614

    Hoover, Alabama, 35244

  • Rehabilitation & Neurological Services /ID# 267612

    Huntsville, Alabama, 35805-4046

  • Alcanza Clinical Research, LLC /ID# 267838

    Lake Mary, Florida, 32746-2118

  • BNL Health - Los Angeles Headache Center /ID# 267570

    Los Angeles, California, 90067-2001

  • Norton Cancer Institute - St. Matthews /ID# 267605

    Louisville, Kentucky, 40207

  • Neuroscience Group /ID# 267571

    Neenah, Wisconsin, 54956-1993

  • Northwell Health /ID# 267596

    New York, New York, 10022-1304

  • Thomas Jefferson University Hospital /ID# 267572

    Philadelphia, Pennsylvania, 19107

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

    Phoenix, Arizona, 85013

Other trials in United States

Spain13 sites

  • Hospital Universitario Vall de Hebron /ID# 268222

    Barcelona, 08035

  • Hospital Universitari de Bellvitge /ID# 268224

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Severo Ochoa /ID# 268249

    Leganés, Madrid, 28911

  • Hospital Universitario de La Princesa /ID# 268245

    Madrid, 28006

  • Hospital Universitario La Paz /ID# 268238

    Madrid, 28046

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

    Majadahonda, Madrid, 28222

  • Hospital Regional Universitario de Malaga /ID# 268272

    Málaga, Andalusia, 29010

  • Hospital Universitario Central de Asturias /ID# 276477

    Oviedo, Principality of Asturias, 33011

  • Hospital Alvaro Cunqueiro /ID# 268248

    Pontevedra, 36312

  • Hospital Universitario Virgen Macarena /ID# 268244

    Seville, Sevilla, 41009

  • Hospital Universitario Virgen del Rocio /ID# 268223

    Seville, 41013

  • Hospital Clinico Universitario de Valladolid /ID# 268225

    Valladolid, 47003

  • Hospital Clinico Universitario Lozano Blesa /ID# 268243

    Zaragoza, 50009

Other trials in Spain

United Kingdom11 sites

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

    Belfast, BT16 1RH

  • University Hospital of Wales /ID# 276822

    Cardiff, CF14 4XW

  • Western General Hospital - NHS Lothian /ID# 277029

    Edinburgh, Edinburgh, City of, EH4 2XU

  • Hull Royal Infirmary /ID# 276819

    Hull, East Riding Of Yorkshire, HU3 2JZ

  • Leeds Teaching Hospitals NHS Trust /ID# 279417

    Leeds, West Yorkshire, LS9 7TF

  • Guy's Hospital /ID# 276817

    London, Greater London, SE1 9RT

  • King's College Hospital /ID# 276818

    London, Greater London, SE5 9RS

  • Cripps Health Centre /ID# 277474

    Nottingham, Nottinghamshire, NG7 2QW

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

    Stoke-on-Trent, Staffordshire, ST4 6QG

  • Great Western Hospital /ID# 276693

    Swindon, Wiltshire, SN3 6BB

  • Worcestershire Royal Hospital /ID# 276902

    Worcester, Worcestershire, WR5 1DD

Other trials in United Kingdom

Canada10 sites

  • Calgary Headache Assessment and Management Program /ID# 270266

    Calgary, Alberta, T3M 1M4

  • Maritime Neurology /ID# 270270

    Halifax, Nova Scotia, B3R 1V9

  • Centre de Recherche St-Louis /ID# 270957

    Lévis, Quebec, G6W 0M5

  • Centricity /ID# 271478

    London, Ontario, N6A 2C2

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

    London, Ontario, N6A 5W9

  • Genge Partners /ID# 270267

    Montreal, Quebec, H4A 3T2

  • Bayshore Neurology /ID# 270673

    Ottawa, Ontario, K2B 8E8

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

    Saint John, New Brunswick, E2K 4P8

  • Sunnybrook Health Sciences Centre /ID# 273207

    Toronto, Ontario, M4N 3M5

  • Burrard Health Center /ID# 270268

    Vancouver, British Columbia, V6Z 2E8

Other trials in Canada

Italy10 sites

  • Azienda Ospedaliero Universitaria delle Marche /ID# 273349

    Ancona, 60126

  • Policlinico di Bari Ospedale Giovanni XXIII /ID# 275336

    Bari, 70126

  • Azienda Ospedaliero-Universitaria Renato Dulbecco /ID# 272696

    Catanzaro, 88100

  • IRCCS Ospedale San Raffaele /ID# 273153

    Milan, Milano, 20132

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 275269

    Naples, Napoli, 80138

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

    Pavia, 27100

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274651

    Rome, Roma, 00133

  • Sapienza University of Rome /ID# 273506

    Rome, Roma, 00161

  • Azienda Sanitaria Universitaria Giuliano Isontina - Trieste /ID# 274413

    Trieste, 34128

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

    Turin, Piedmont, 10126

Other trials in Italy

Switzerland10 sites

  • ZURZACH Care /ID# 265697

    Bad Zurzach, Canton of Aargau, 5330

  • Inselspital, Universitaetsspital Bern /ID# 265818

    Bern, 3010

  • CHUV, Centre hospitalier universitaire vaudois /ID# 266551

    Lausanne, Canton of Vaud, 1011

  • DYA Swiss Institut SA /ID# 266891

    Lugano, Canton Ticino, 6900

  • EOC Ospedale Regionale Lugano /ID# 266887

    Lugano, Canton Ticino, 6900

  • NeuroPraxis Birseck /ID# 266140

    Reinach, Basel-Landschaft, 4153

  • Hôpital De Sion /ID# 276360

    Sion, Valais, 1951

  • Kopfwehzentrum Hirslanden Zuerich /ID# 265817

    Zollikon, Canton of Zurich, 8702

  • Neurozentrum Bellevue /ID# 277666

    Zurich, Canton of Zurich, 8001

  • University Hospital Zurich /ID# 276450

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Belgium8 sites

  • OLV Ziekenhuis Aalst /ID# 270284

    Aalst, Oost-Vlaanderen, 9300

  • Algemeen Ziekenhuis Sint-Jan Brugge /ID# 270540

    Bruges, West-Vlaanderen, 8000

  • Cliniques Universitaires UCL Saint-Luc /ID# 270545

    Brussels, Brussels Capital, 1200

  • Universitair Ziekenhuis Brussel /ID# 269799

    Jette, Brussels Capital, 1090

  • AZ Groeninge /ID# 272772

    Kortrijk, West-Vlaanderen, 8500

  • Chu Tivoli /ID# 271254

    La Louvière, Hainaut, 7100

  • Centre Hospitalier Régional de la Citadelle /ID# 270539

    Liège, Liege, 4000

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

    Liège, Liege, 4000

Other trials in Belgium

Portugal7 sites

  • Hospital CUF Coimbra /ID# 272393

    Coimbra, 3000-600

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

    Guimarães, Braga District, 4835-044

  • Hospital da Luz /ID# 267002

    Lisbon, Lisbon District, 1500-650

  • Unidade Local de Saude de Loures-Odivelas /ID# 274764

    Loures, Lisbon District, 2674-514

  • Hospital CUF Porto /ID# 272788

    Porto, 4100-180

  • CUF Sintra Hospital /ID# 272394

    Sintra, Lisbon District, 2710-204

  • Campus Neurológico Sénior /ID# 272392

    Torres Vedras, Lisbon District, 2560-280

Other trials in Portugal

Netherlands5 sites

  • Gelre Ziekenhuis /ID# 272429

    Apeldoorn, Gelderland, 7334 DZ

  • Maasstad Ziekenhuis /ID# 269601

    Rotterdam, South Holland, 3079 DZ

  • Maxima Medisch Centrum, Locatie Veldhoven /ID# 270278

    Veldhoven, North Brabant, 5504 DB

  • Zaans Medisch Centrum /ID# 269603

    Zaandam, North Holland, 1502 DV

  • Isala, locatie Zwolle /ID# 269602

    Zwolle, Overijssel, 8025 AB

Other trials in Netherlands

Sweden3 sites

  • Karolinska Universitetssjukhuset - Huddinge /ID# 265295

    Huddinge, Stockholm County, 141 57

  • Skaneuro /ID# 265203

    Lund, 222 22

  • Neurology Clinic /ID# 266707

    Stockholm, Stockholm County, 114 33

Other trials in Sweden

Taiwan3 sites

  • Taipei Veterans General Hospital /ID# 272083

    Taipei, 112

  • Tri-Service General Hospital /ID# 272082

    Taipei, 114

  • Linkou Chang Gung Memorial Hospital /ID# 272084

    Taoyuan City, 333

Other trials in Taiwan

Norway2 sites

  • Oslo Hodepinesenter AS /ID# 271384

    Oslo, 0275

  • Hodeverket /ID# 271383

    Sandnes, Rogaland, 4319

Other trials in Norway

United Arab Emirates2 sites

  • Harley Street Medical Centre /ID# 276430

    Abu Dhabi, 000000

  • American Center of Neurology and Psychiatry /ID# 276429

    Abu Dhabi

Other trials in United Arab Emirates

About this study

Official title: A ProspeCtive ObseRvatioNal Study of Atogepant Effectiveness in Routine Clinical Practice

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.

Read more

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
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06543914
Study groupRoleWhat they receive
AtogepantParticipants will receive atogepant as prescribed by their physician in routine clinical practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start26 Nov 2024
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06543914
Sponsor's protocol ID
P24-880
Acronym
CORNERSTONE
Status last verified
May 2026
First submitted
6 Aug 2024
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine, run by AbbVie at 112 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in Germany, United States, Spain, United Kingdom, Canada and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving a rating of "much better" or "very much better" as assessed by the Patient Global Impression of Change (PGI-C) (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06543914.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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