RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A ProspeCtive ObseRvatioNal Study of Atogepant Effectiveness in Routine Clinical Practice

Quick Facts

Study Start:2024-11-26
Study Completion:2029-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06543914

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Prescribed atogepant according to the relevant approved local label.
  3. * 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.
  4. * Willing and able to comply with the requirements of the study.
  5. * 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.
  1. * Previously exposed to atogepant as routine therapy or from clinical trials experience prior to entry.
  2. * Contraindications to atogepant as per local labeling.
  3. * Pregnant or planning to be pregnant or women of childbearing potential not using contraception.
  4. * Enrolled in any interventional studies that may include investigational compounds for migraine, or non-AbbVie observational studies.
  5. * 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.

Contacts and Locations

Study Contact

Sarah Caughlin
CONTACT
sarah.caughlin@abbvie.com

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

Neurology and Neurodiagnostics of Alabama /ID# 267614
Hoover, Alabama, 35244
United States
Kenneth Martinez MD, A Medical Corp /ID# 267834
Aliso Viejo, California, 92656
United States
Los Angeles Headache Center /ID# 267570
Los Angeles, California, 90067-2001
United States
Alcanza Clinical Research, LLC /ID# 267838
Lake Mary, Florida, 32746-2118
United States
Dent Neurologic Group, Llp /Id# 267606
Amherst, New York, 14226-1723
United States
Grace Forde /ID# 267596
N. New Hyde Park, New York, 11042-2040
United States
Neuroscience Group /ID# 267571
Neenah, Wisconsin, 54956-1993
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-26
Study Completion Date2029-02

Study Record Updates

Study Start Date2024-11-26
Study Completion Date2029-02

Terms related to this study

Keywords Provided by Researchers

  • Migraine
  • Atogepant
  • Qulipta
  • Aquipta

Additional Relevant MeSH Terms

  • Migraine