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 | Recruiting

• 1 other identifier: P24-480
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Episodic Migraine; Migraine; Chronic Migraine

Keywords

Chronic Migraine; Episodic Migraine; Migraine; Atogepant; Qulipta; Aquipta

Outcome Measures

Primary Outcomes (10)

• Percentage (%) of participants who reported serious adverse event (SAE)/drug reaction (SADR)

  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)

  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

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

  Up to approximately 16 Weeks

• Percentage (%) of participants who reported non-serious AE/ADR

  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)

  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

  Percentage (%) of participants with AE: overall summary

  Up to approximately 16 Weeks

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

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

  Up to approximately 16 Weeks

• Percentage (%) of participants with AE leading to treatment discontinuation

  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

  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

  Percentage (%) of participants who reported treatment-related serious AE per the investigator causality assessment

  Up to approximately 16 Weeks

Study Arms (1)

Atogepant

Participants will receive atogepant as prescribed by their physician according to the local label.

Drug: Atogepant

Interventions

Atogepant DRUG

Oral Tablet

Also known as: Qulipta, Aquipta

Atogepant

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (4)

Hallym University Dongtan Sacred Heart Hospital /ID# 273581

Hwaseong, Gyeonggido, 18450, South Korea

RECRUITING

Seoul National University Hospital /ID# 271892

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

Kangbuk Samsung Hospital /ID# 271893

Seoul, Seoul Teugbyeolsi, 03181, South Korea

RECRUITING

Yonsei University Health System Severance Hospital /ID# 272639

Seoul, Seoul Teugbyeolsi, 03722, South Korea

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Migraine Disorders

Interventions

atogepant

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Celine Im

CONTACT

+82-10-2230-3629; celine.im@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

KR (4)