Observational Study of Oral Atogepant to Evaluate Real-World Effectiveness in Adult Participants With Migraine
- Conditions
- Migraine
- Registration Number
- NCT06543914
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving a rating of "much better" or "very much better" as assessed by the Patient Global Impression of Change (PGI-C) Week 12 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".
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (54)
Neurology and Neurodiagnostics of Alabama /ID# 267614
🇺🇸Hoover, Alabama, United States
Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 267610
🇺🇸Phoenix, Arizona, United States
Kenneth Martinez MD, A Medical Corp /ID# 267834
🇺🇸Aliso Viejo, California, United States
Los Angeles Headache Center /ID# 267570
🇺🇸Los Angeles, California, United States
Alcanza Clinical Research, LLC /ID# 267838
🇺🇸Lake Mary, Florida, United States
Norton Healthcare /ID# 267605
🇺🇸Louisville, Kentucky, United States
Dent Neurologic Institute - Amherst /ID# 267606
🇺🇸Amherst, New York, United States
Grace Forde /ID# 267596
🇺🇸N. New Hyde Park, New York, United States
Thomas Jefferson University Hospital /ID# 267572
🇺🇸Philadelphia, Pennsylvania, United States
Inova Health Care System /ID# 267615
🇺🇸Falls Church, Virginia, United States
Neuroscience Group /ID# 267571
🇺🇸Neenah, Wisconsin, United States
Cliniques Universitaires UCL Saint-Luc /ID# 270545
🇧🇪Bruxelles, Bruxelles-Capitale, Belgium
Universitair Ziekenhuis Brussel /ID# 269799
🇧🇪Jette, Bruxelles-Capitale, Belgium
Chu Tivoli /ID# 271254
🇧🇪La Louvière, Hainaut, Belgium
Centre Hospitalier Régional de la Citadelle /ID# 270539
🇧🇪Liège, Liege, Belgium
Onze Lieve Vrouw Ziekenhuis Aalst /ID# 270284
🇧🇪Aalst, Oost-Vlaanderen, Belgium
AZ Groeninge /ID# 272772
🇧🇪Kortrijk, West-Vlaanderen, Belgium
AZ Sint-Jan Brugge /ID# 270540
🇧🇪Brugge, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 270218
🇧🇪Liege, Belgium
Burrard Health Center /ID# 270268
🇨🇦Vancouver, British Columbia, Canada
Dr. Renju Kuriakose Prof. Corp. /ID# 273178
🇨🇦Saint John, New Brunswick, Canada
Maritime Neurology /ID# 270270
🇨🇦Halifax, Nova Scotia, Canada
Centricity /ID# 271478
🇨🇦London, Ontario, Canada
Bayshore Neurology /ID# 270673
🇨🇦Ottawa, Ontario, Canada
Centre de Recherche St-Louis /ID# 270957
🇨🇦Lévis, Quebec, Canada
Genge Partners /ID# 270267
🇨🇦Montreal, Quebec, Canada
Praxis fur Neurologie Dr. med. Martin Delf /ID# 275918
🇩🇪Hoppegarten, Brandenburg, Germany
Zentrum Für Klinische Forschung Dr. Irma Schöll /ID# 275642
🇩🇪Bad Homburg, Hessen, Germany
ZNS Siegen /ID# 275660
🇩🇪Siegen, Nordrhein-Westfalen, Germany
Schmerzklinik Kiel /ID# 275592
🇩🇪Kiel, Schleswig-Holstein, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275760
🇩🇪Berlin, Germany
Schmerzzentrum Berlin /ID# 275819
🇩🇪Berlin, Germany
Neurologischen Facharztzentrum Berlin /ID# 275919
🇩🇪Berlin, Germany
Städtisches Klinikum Brandenburg /ID# 275725
🇩🇪Brandenburg, Germany
Gelre Ziekenhuis /ID# 272429
🇳🇱Apeldoorn, Gelderland, Netherlands
Isala, locatie Zwolle /ID# 269602
🇳🇱Zwolle, Overijssel, Netherlands
Hospital da Luz /ID# 267002
🇵🇹Lisbon, Lisboa, Portugal
Campus Neurológico Sénior /ID# 272392
🇵🇹Torres Vedras, Lisboa, Portugal
Hospital CUF Porto /ID# 272788
🇵🇹Porto, Portugal
Hospital Regional Universitario de Malaga /ID# 268272
🇪🇸Malaga, Andalucia, Spain
Hospital Universitario Severo Ochoa /ID# 268249
🇪🇸Leganés, Madrid, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 268246
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario Virgen Macarena /ID# 268244
🇪🇸Seville, Sevilla, Spain
Hospital Universitario de La Princesa /ID# 268245
🇪🇸Madrid, Spain
Hospital Universitario La Paz /ID# 268238
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio /ID# 268223
🇪🇸Sevilla, Spain
Hospital Clinico Universitario de Valladolid /ID# 268225
🇪🇸Valladolid, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 268243
🇪🇸Zaragoza, Spain
ZURZACH Care /ID# 265697
🇨🇭Bad Zurzach, Aargau, Switzerland
DYA Swiss Institut SA /ID# 266891
🇨🇭Lugano, Ticino, Switzerland
EOC Ospedale Regionale Lugano /ID# 266887
🇨🇭Lugano, Ticino, Switzerland
CHUV, Centre hospitalier universitaire vaudois /ID# 266551
🇨🇭Lausanne, Vaud, Switzerland
Kopfwehzentrum Hirslanden Zuerich /ID# 265817
🇨🇭Zollikon, Zuerich, Switzerland
Great Western Hospital /ID# 276693
🇬🇧Swindon, Wiltshire, United Kingdom