Post-marketing Surveillance Study to Evaluate the Safety and Effectiveness of Atogepant for the Prevention of Migraine in Korean Adult Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 3,000
- Locations
- 40
- Primary Endpoint
- Percentage (%) of participants who reported serious adverse event (SAE)/drug reaction (SADR)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Atogepant
Participants will receive atogepant as prescribed by their physician according to the local label.
Intervention: Atogepant (Drug)
Outcomes
Primary Outcomes
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)
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)
Percentage (%) of participants who reported known (labeled) ADR
Time Frame: Up to approximately 16 Weeks
Percentage (%) of participants who reported known (labeled) ADR
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
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
Percentage (%) of participants with AE: overall summary
Time Frame: Up to approximately 16 Weeks
Percentage (%) of participants with AE: overall summary
Percentage (%) of participants with common (>=5%) AE
Time Frame: Up to approximately 16 Weeks
Percentage (%) of participants with common (\>=5%) AE
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
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
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
Secondary Outcomes
No secondary outcomes reported