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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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.

Study details
    Migraine

NCT06543914

AbbVie

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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