Evaluating the effectiveness of atogepant for migraine treatment in adults
A ProspeCtive ObseRvatioNal Study of Atogepant Effectiveness in Routine Clinical Practice
This study is testing how well atogepant works for preventing migraines in adults by following about 1000 people over two years as they use the medication in their everyday lives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 111 sites (Hoover, Alabama and 110 other locations) |
| Trial ID | NCT06543914 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the real-world effectiveness of atogepant, an approved medication for migraine prevention, in adult participants. Approximately 1000 adults with a history of migraine will be enrolled globally and prescribed atogepant as part of their routine clinical care. Participants will be monitored over a two-year period, attending regular visits at their healthcare facilities without any additional burdens. The study will gather data on the medication's effectiveness in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are adults with a history of migraine who have been prescribed atogepant as part of their routine care.
Not a fit: Patients who are currently on other preventive migraine medications or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of atogepant for migraine management in everyday clinical practice.
How similar studies have performed: Other studies have shown positive outcomes with similar approaches in evaluating real-world effectiveness of migraine treatments, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hoover, Alabama and 110 other locations
- Neurology and Neurodiagnostics of Alabama /ID# 267614 — Hoover, Alabama, United States (Completed)
- Rehabilitation & Neurological Services /ID# 267612 — Huntsville, Alabama, United States (Recruiting)
- Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 267610 — Phoenix, Arizona, United States (Recruiting)
- Kenneth Martinez MD, A Medical Corp /ID# 267834 — Aliso Viejo, California, United States (Recruiting)
- Los Angeles Headache Center /ID# 267570 — Los Angeles, California, United States (Recruiting)
- Alcanza Clinical Research, LLC /ID# 267838 — Lake Mary, Florida, United States (Recruiting)
- Norton Cancer Institute - St. Matthews /ID# 267605 — Louisville, Kentucky, United States (Completed)
- Dent Neurologic Institute - Amherst /ID# 267606 — Amherst, New York, United States (Recruiting)
- Northwell Health - Great Neck /ID# 280705 — Great Neck, New York, United States (Completed)
- Northwell Health /ID# 267596 — New York, New York, United States (Recruiting)
- Thomas Jefferson University Hospital /ID# 267572 — Philadelphia, Pennsylvania, United States (Recruiting)
- Inova Health Care System /ID# 267615 — Falls Church, Virginia, United States (Recruiting)
- Neuroscience Group /ID# 267571 — Neenah, Wisconsin, United States (Recruiting)
- Cliniques Universitaires UCL Saint-Luc /ID# 270545 — Brussels, Brussels Capital, Belgium (Recruiting)
- Universitair Ziekenhuis Brussel /ID# 269799 — Jette, Brussels Capital, Belgium (Active_not_recruiting)
- Chu Tivoli /ID# 271254 — La Louvière, Hainaut, Belgium (Recruiting)
- Centre Hospitalier Régional de la Citadelle /ID# 270539 — Liège, Liege, Belgium (Recruiting)
- Groupe Sante CHC - Clinique du MontLegia /ID# 270218 — Liège, Liege, Belgium (Active_not_recruiting)
- OLV Ziekenhuis Aalst /ID# 270284 — Aalst, Oost-Vlaanderen, Belgium (Active_not_recruiting)
- AZ Sint-Jan Brugge /ID# 270540 — Bruges, West-Vlaanderen, Belgium (Active_not_recruiting)
- AZ Groeninge /ID# 272772 — Kortrijk, West-Vlaanderen, Belgium (Active_not_recruiting)
- Calgary Headache Assessment and Management Program /ID# 270266 — Calgary, Alberta, Canada (Recruiting)
- Burrard Health Center /ID# 270268 — Vancouver, British Columbia, Canada (Recruiting)
- Dr. Renju Kuriakose Prof. Corp. /ID# 273178 — Saint John, New Brunswick, Canada (Recruiting)
- Maritime Neurology /ID# 270270 — Halifax, Nova Scotia, Canada (Recruiting)
- Centricity /ID# 271478 — London, Ontario, Canada (Recruiting)
- London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270943 — London, Ontario, Canada (Recruiting)
- Bayshore Neurology /ID# 270673 — Ottawa, Ontario, Canada (Recruiting)
- Sunnybrook Health Sciences Centre /ID# 273207 — Toronto, Ontario, Canada (Recruiting)
- Centre de Recherche St-Louis /ID# 270957 — Lévis, Quebec, Canada (Recruiting)
- Genge Partners /ID# 270267 — Montreal, Quebec, Canada (Recruiting)
- Universitaetsklinikum Heidelberg /ID# 278134 — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
- Universitaetsklinikum Tuebingen /ID# 275762 — Tübingen, Baden-Wurttemberg, Germany (Recruiting)
- Praxis fur Neurologie Dr. med. Martin Delf /ID# 275918 — Hoppegarten, Brandenburg, Germany (Recruiting)
- Zentrum Für Klinische Forschung Dr. Irma Schöll /ID# 275642 — Bad Homburg, Hesse, Germany (Recruiting)
- Evangelisches Krankenhaus Oldenburg /ID# 275823 — Oldenburg, Lower Saxony, Germany (Recruiting)
- Universitaetsmedizin Greifswald /ID# 276678 — Greifswald, Mecklenburg-Vorpommern, Germany (Recruiting)
- ZNS Siegen /ID# 275660 — Siegen, North Rhine-Westphalia, Germany (Recruiting)
- Dres. Huhn-Doll/Siquet/Vocke /ID# 279583 — Velbert, North Rhine-Westphalia, Germany (Recruiting)
- Universitaetsklinikum Carl Gustav Carus Dresden /ID# 275759 — Dresden, Saxony, Germany (Recruiting)
- Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 281667 — Kiel, Schleswig-Holstein, Germany (Recruiting)
- Schmerzklinik Kiel /ID# 275592 — Kiel, Schleswig-Holstein, Germany (Recruiting)
- Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275760 — Berlin, Germany (Recruiting)
- Schmerzzentrum Berlin /ID# 275819 — Berlin, Germany (Recruiting)
- Neurologischen Facharztzentrum Berlin /ID# 275919 — Berlin, Germany (Recruiting)
- Städtisches Klinikum Brandenburg /ID# 275725 — Brandenburg, Germany (Recruiting)
- IRCCS Ospedale San Raffaele /ID# 273153 — Milan, Milano, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 275269 — Naples, Napoli, Italy (Recruiting)
- A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274426 — Turin, Piedmont, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274651 — Rome, Roma, Italy (Recruiting)
+61 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Krystal Spenta
- Email: krystal.spenta@abbvie.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.