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

Sponsor
AbbVie
Study ID
NCT06603558
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 24, 2024
Status verified
May 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: Atogepant
    Participants will receive atogepant as prescribed by their physician according to the local label.

Primary Outcome Measure

Percentage (%) of participants who reported serious adverse event (SAE)/drug reaction (SADR) [ Time Frame: Up to approximately 16 Weeks ]

Central Contacts

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