NCT06543914 Observational Study of Oral Atogepant to Evaluate Real-World Effectiveness in Adult Participants With Migraine
| NCT ID | NCT06543914 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AbbVie |
| Condition | Migraine |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-11-26 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-11-26 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Krystal Spenta
✉ krystal.spenta@abbvie.comABBVIE INC.
STUDY DIRECTOR
AbbVie
Frequently Asked Questions
Who can join the NCT06543914 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06543914 currently recruiting?
Yes, NCT06543914 is actively recruiting participants. Contact the research team at krystal.spenta@abbvie.com for enrollment information.
Where is the NCT06543914 trial being conducted?
This trial is being conducted at Hoover, United States, Huntsville, United States, Phoenix, United States, Aliso Viejo, United States and 11 additional locations.
Who is sponsoring the NCT06543914 clinical trial?
NCT06543914 is sponsored by AbbVie. The principal investigator is ABBVIE INC. at AbbVie. The trial plans to enroll 1,000 participants.
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