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Clinical Trials in South Korea / NCT06603558
Recruiting Observational

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

NCT06603558 · tracked via the Priya Life Science South Korea tracker
Sponsor
AbbVie
Phase
Observational
Started
2024-09-24
Last updated
2026-07-22

Condition(s) studied

Chronic MigraineEpisodic MigraineMigraine

Investigational drug(s) / intervention(s)

Atogepant →

Atogepant: Oral Tablet

Study summary

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (36)

FacilityCityRegionStatus
On Hospital /ID# 285157 Busan Busan Gwang Yeogsi Recruiting
Ryu Sang Hyo Neurosurgery Clinic /ID# 284804 Busan Busan Gwang Yeogsi Recruiting
Dong-A University Medical Center /ID# 275321 Busan Busan Gwang Yeogsi Recruiting
Chungnam National University Hospital /ID# 284724 Daejeon Daejeon Gwang Yeogsi Recruiting
Chuncheon Sacred Heart Hospital /ID# 275315 Gangwon-do Gang Weondo Recruiting
Chonnam National University Hospital /ID# 275318 Gwangju Gwangju Gwang Yeogsi Recruiting
Korea University Ansan Hospital /ID# 284725 Ansan-si Gyeonggido Recruiting
Inje University - Ilsan Paik Hospital /ID# 280738 Goyang Gyeonggido Recruiting
National Health Insurance Corporation Ilsan Hospital /ID# 285128 Goyang-si Gyeonggido Recruiting
Hallym University Dongtan Sacred Heart Hospital /ID# 273581 Hwaseong Gyeonggido Recruiting
Hallym University Dongtan Sacred Heart Hospital /ID# 280737 Hwaseong Gyeonggido Recruiting
Teunteun Hospital /ID# 284730 Hwaseong-si Gyeonggido Recruiting
Life Neurology Clinic /ID# 284729 Hwaseong-si Gyeonggido Recruiting
Gachon University Gil Medical Center /ID# 284571 Incheon Gyeonggido Recruiting
Seoul National University Bundang Hospital /ID# 284508 Seongnam-si Gyeonggido Recruiting
Ajou University Hospital - Suwon-si /ID# 284574 Suwon Gyeonggido Recruiting
Hwahong Hospital /ID# 284803 Suwon Gyeonggido Recruiting
Uijeongbu Eulji Medical Center - Eulji University /ID# 284855 Uijeongbu-si Gyeonggido Recruiting
Yongin Severance Hospital /ID# 284570 Yongin-si Gyeonggido Recruiting
Daegu Catholic University Medical Center /ID# 284728 Daegu Gyeongsangbuk-do Recruiting
Keimyung University Dongsan Hospital /ID# 284727 Daegu Gyeongsangbuk-do Recruiting
Changwon Fatima Hospital /ID# 284572 Changwon-si Gyeongsangnam-do Recruiting
The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 284568 Incheon Incheon Gwang Yeogsi Recruiting
Inha University Hospital /ID# 275320 Incheon Incheon Gwang Yeogsi Recruiting
Wonkwang University Hospital /ID# 284567 Iksan Jeonrabugdo Recruiting
Jeonbuk National University Hospital /ID# 273583 Jeonju Jeonrabugdo Recruiting
Nowon Eulji Medical Center, Eulji University /ID# 275316 Seoul Seoul Teugbyeolsi Recruiting
Korea University Anam Hospital /ID# 284726 Seoul Seoul Teugbyeolsi Recruiting
Seoul National University Hospital /ID# 271892 Seoul Seoul Teugbyeolsi Recruiting
Seoul National University Hospital /ID# 272638 Seoul Seoul Teugbyeolsi Recruiting
Kangbuk Samsung Hospital /ID# 271893 Seoul Seoul Teugbyeolsi Recruiting
Yonsei University Health System Severance Hospital /ID# 272639 Seoul Seoul Teugbyeolsi Recruiting
Samsung Medical Center /ID# 272640 Seoul Seoul Teugbyeolsi Recruiting
Ewha Womans University Medical Centre /ID# 275317 Seoul Seoul Teugbyeolsi Recruiting
Korea University Guro Hospital /ID# 284569 Seoul Seoul Teugbyeolsi Recruiting
Hallym University Kangdong Sacred Heart Hospital /ID# 284573 Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06603558 on ClinicalTrials.gov ↗ ← All trials in South Korea