A ProspeCtive ObseRvatioNal Study of Atogepant Effectiveness in Routine Clinical Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,314
- Locations
- 219
- Primary Endpoint
- Percentage of Participants Achieving a rating of "much better" or "very much better" as assessed by the Patient Global Impression of Change (PGI-C)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
- •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.
Arms & Interventions
Atogepant
Participants will receive atogepant as prescribed by their physician in routine clinical practice.
Outcomes
Primary Outcomes
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
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 Outcomes
No secondary outcomes reported