Post-Marketing Study to Assess the Safety and Effectiveness of Oral Atogepant in Korean Adult Participants for the Prevention of Chronic or Episodic Migraine (Atogepant PMSS)

May 21, 2026 updated by: AbbVie

Post-marketing Surveillance Study to Evaluate the Safety and Effectiveness of Atogepant for the Prevention of Migraine in Korean Adult Patients

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The study will assess the safety and effectiveness of atogepant for the preventive treatment of migraine in Korean adult patients with chronic migraine or episodic migraine under routine clinical practice.

Atogepant is an approved drug for preventive treatment of migraine in adults. Approximately 3000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study in Korea.

Participants will receive atogepant oral tablets as prescribed by their physician. Participants will be followed for up to week 12.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Gyeonggido
      • Hwaseong, Gyeonggido, South Korea, 18450
        • Recruiting
        • Hallym University Dongtan Sacred Heart Hospital /ID# 273581
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital /ID# 271892
      • Seoul, Seoul Teugbyeolsi, South Korea, 03181
        • Recruiting
        • Kangbuk Samsung Hospital /ID# 271893
      • Seoul, Seoul Teugbyeolsi, South Korea, 03722
        • Recruiting
        • Yonsei University Health System Severance Hospital /ID# 272639

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants who have been prescribed atogepant for preventive treatment migraine according to the latest approved local label in routine clinical practice.

Description

Inclusion Criteria:

  • Participants with migraine suitable for the treatment with atogepant according to the latest approved local label.
  • Participants prescribed atogepant in accordance with the approved local label.

Exclusion Criteria:

  • Participants with any contraindication to atogepant as listed on the latest approved local label.
  • Participants currently participating in another clinical research except observational study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atogepant
Participants will receive atogepant as prescribed by their physician according to the local label.
Drug: Atogepant
Oral Tablet
Other Names:
  • Qulipta
  • Aquipta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage (%) of participants who reported serious adverse event (SAE)/drug reaction (SADR)
Time Frame: Up to approximately 16 Weeks
Percentage (%) of participants who reported serious adverse event (SAE)/drug reaction (SADR)
Up to approximately 16 Weeks
Percentage (%) of participants who reported unexpected (not reflected in the latest approved label) adverse event (AE)/drug reaction (ADR)
Time Frame: Up to approximately 16 Weeks
Percentage (%) of participants who reported unexpected (not reflected in the latest approved label) adverse event (AE)/drug reaction (ADR)
Up to approximately 16 Weeks
Percentage (%) of participants who reported known (labeled) ADR
Time Frame: Up to approximately 16 Weeks
Percentage (%) of participants who reported known (labeled) ADR
Up to approximately 16 Weeks
Percentage (%) of participants who reported non-serious AE/ADR
Time Frame: Up to approximately 16 Weeks
Percentage (%) of participants who reported non-serious AE/ADR
Up to approximately 16 Weeks
Percentage (%) of participants who reported the events related to important potential risks and missing information defined in the Risk Management Plan (RMP)
Time Frame: Up to approximately 16 Weeks
Percentage (%) of participants who reported the events related to important potential risks and missing information defined in the RMP
Up to approximately 16 Weeks
Percentage (%) of participants with AE: overall summary
Time Frame: Up to approximately 16 Weeks
Percentage (%) of participants with AE: overall summary
Up to approximately 16 Weeks
Percentage (%) of participants with common (>=5%) AE
Time Frame: Up to approximately 16 Weeks
Percentage (%) of participants with common (>=5%) AE
Up to approximately 16 Weeks
Percentage (%) of participants with AE leading to treatment discontinuation
Time Frame: Up to approximately 16 Weeks
Percentage (%) of participants with AE leading to treatment discontinuation
Up to approximately 16 Weeks
Percentage (%) of participants who reported treatment-related AE per the investigator causality assessment
Time Frame: Up to approximately 16 Weeks
Percentage (%) of participants who reported treatment-related AE per the investigator causality assessment
Up to approximately 16 Weeks
Percentage (%) of participants who reported treatment-related serious AE per the investigator causality assessment
Time Frame: Up to approximately 16 Weeks
Percentage (%) of participants who reported treatment-related serious AE per the investigator causality assessment
Up to approximately 16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

September 24, 2024

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P24-480

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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