Clinical trial NCT06543914: Observational Study of Oral Atogepant to Evaluate Real-World Effectiveness in Adult Participants With Migraine
Official title: A ProspeCtive ObseRvatioNal Study of Atogepant Effectiveness in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Keywords: Migraine
Atogepant
Qulipta
Aquipta
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with migraine who are prescribed atogepant by their physician per routine standard of care

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.


Eligibility 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.

Primary outcomes:
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)
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Neurology and Neurodiagnostics of Alabama /ID# 267614
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 267610
state: Arizona
city: Aliso Viejo
country: United States
facility: Kenneth Martinez MD, A Medical Corp /ID# 267834
state: California
city: Los Angeles
country: United States
facility: Los Angeles Headache Center /ID# 267570
state: California
city: Lake Mary
country: United States
facility: Alcanza Clinical Research, LLC /ID# 267838
state: Florida
city: Louisville
country: United States
facility: Norton Healthcare /ID# 267605
state: Kentucky
city: Amherst
country: United States
facility: Dent Neurologic Institute - Amherst /ID# 267606
state: New York
city: N. New Hyde Park
country: United States
facility: Grace Forde /ID# 267596
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital /ID# 267572
state: Pennsylvania
city: Falls Church
country: United States
facility: Inova Health Care System /ID# 267615
state: Virginia
city: Neenah
country: United States
facility: Neuroscience Group /ID# 267571
state: Wisconsin
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 270545
state: Bruxelles-Capitale
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel /ID# 269799
state: Bruxelles-Capitale
city: La Louvière
country: Belgium
facility: Chu Tivoli /ID# 271254
state: Hainaut
city: Liège
country: Belgium
facility: Centre Hospitalier Régional de la Citadelle /ID# 270539
state: Liege
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis Aalst /ID# 270284
state: Oost-Vlaanderen
city: Kortrijk
country: Belgium
facility: AZ Groeninge /ID# 272772
state: West-Vlaanderen
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge /ID# 270540
city: Liege
country: Belgium
facility: Groupe Sante CHC - Clinique du MontLegia /ID# 270218
city: Vancouver
country: Canada
facility: Burrard Health Center /ID# 270268
state: British Columbia
city: Saint John
country: Canada
facility: Dr. Renju Kuriakose Prof. Corp. /ID# 273178
state: New Brunswick
city: Halifax
country: Canada
facility: Maritime Neurology /ID# 270270
state: Nova Scotia
city: London
country: Canada
facility: Centricity /ID# 271478
state: Ontario
city: Ottawa
country: Canada
facility: Bayshore Neurology /ID# 270673
state: Ontario
city: Lévis
country: Canada
facility: Centre de Recherche St-Louis /ID# 270957
state: Quebec
city: Montreal
country: Canada
facility: Genge Partners /ID# 270267
state: Quebec
city: Hoppegarten
country: Germany
facility: Praxis fur Neurologie Dr. med. Martin Delf /ID# 275918
state: Brandenburg
city: Bad Homburg
country: Germany
facility: Zentrum Für Klinische Forschung Dr. Irma Schöll /ID# 275642
state: Hessen
city: Siegen
country: Germany
facility: ZNS Siegen /ID# 275660
state: Nordrhein-Westfalen
city: Kiel
country: Germany
facility: Schmerzklinik Kiel /ID# 275592
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275760
city: Berlin
country: Germany
facility: Schmerzzentrum Berlin /ID# 275819
city: Berlin
country: Germany
facility: Neurologischen Facharztzentrum Berlin /ID# 275919
city: Brandenburg
country: Germany
facility: Städtisches Klinikum Brandenburg /ID# 275725
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuis /ID# 272429
state: Gelderland
city: Zwolle
country: Netherlands
facility: Isala, locatie Zwolle /ID# 269602
state: Overijssel
city: Lisbon
country: Portugal
facility: Hospital da Luz /ID# 267002
state: Lisboa
city: Torres Vedras
country: Portugal
facility: Campus Neurológico Sénior /ID# 272392
state: Lisboa
city: Porto
country: Portugal
facility: Hospital CUF Porto /ID# 272788
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga /ID# 268272
state: Andalucia
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa /ID# 268249
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda /ID# 268246
state: Madrid
city: Seville
country: Spain
facility: Hospital Universitario Virgen Macarena /ID# 268244
state: Sevilla
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa /ID# 268245
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 268238
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 268223
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid /ID# 268225
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa /ID# 268243
city: Bad Zurzach
country: Switzerland
facility: ZURZACH Care /ID# 265697
state: Aargau
city: Lugano
country: Switzerland
facility: DYA Swiss Institut SA /ID# 266891
state: Ticino
city: Lugano
country: Switzerland
facility: EOC Ospedale Regionale Lugano /ID# 266887
state: Ticino
city: Lausanne
country: Switzerland
facility: CHUV, Centre hospitalier universitaire vaudois /ID# 266551
state: Vaud
city: Zollikon
country: Switzerland
facility: Kopfwehzentrum Hirslanden Zuerich /ID# 265817
state: Zuerich
city: Swindon
country: United Kingdom
facility: Great Western Hospital /ID# 276693
state: Wiltshire
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: