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

Recruiting

• Conditions: Migraine

• Registration Number: NCT06543914
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-09
• Study Start: 2024-11-26
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-14
• Primary Completion: 2029-02
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving a rating of "much better" or "very much better" as assessed by the Patient Global Impression of Change (PGI-C)	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".

Trial Locations

Locations (80)

Norton Cancer Institute - St. Matthews /ID# 267605; 🇺🇸 Louisville, Kentucky, United States

OLV Ziekenhuis Aalst /ID# 270284; 🇧🇪 Aalst, Oost-Vlaanderen, Belgium

Universitaetsklinikum Heidelberg /ID# 278134; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany

IRCCS Ospedale San Raffaele /ID# 273153; 🇮🇹 Milan, Milano, Italy

Sapienza University of Rome /ID# 273506; 🇮🇹 Rome, Roma, Italy

Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 273155; 🇮🇹 Pavia, Italy

Karolinska Universitetssjukhuset - Huddinge /ID# 265295; 🇸🇪 Huddinge, Stockholms Lan, Sweden

Neurology Clinic /ID# 266707; 🇸🇪 Stockholm, Stockholms Lan, Sweden

Skaneuro /ID# 265203; 🇸🇪 Lund, Sweden

Tri-Service General Hospital /ID# 272082; 🇨🇳 Taipei, Taiwan

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