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NCT Number: NCT06603558

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

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.

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Key information

Conditions

Chronic Migraine Brain Diseases Central Nervous System Diseases Episodic Migraine Headache Disorders Headache Disorders, Primary Migraine Migraine Disorders Nervous System Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dong-A University Medical Center /ID# 275321, Busan, Busan Gwang Yeogsi, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atogepant

Drug

Oral Tablet

Other names: Qulipta, Aquipta

Primary outcomes

  1. 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)

  2. 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)

  3. Percentage (%) of participants who reported known (labeled) ADR

    Time frame: Up to approximately 16 Weeks

    Percentage (%) of participants who reported known (labeled) ADR

  4. 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

  5. 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

  6. Percentage (%) of participants with AE: overall summary

    Time frame: Up to approximately 16 Weeks

    Percentage (%) of participants with AE: overall summary

  7. Percentage (%) of participants with common (>=5%) AE

    Time frame: Up to approximately 16 Weeks

    Percentage (%) of participants with common (>=5%) AE

  8. 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

  9. 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

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Celine Im

CONTACT

[email protected]

+82-10-2230-3629

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: Atogepant PMSS

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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