Chronic Migraine, Episodic Migraine, Migraine
Conditions
Keywords
Chronic Migraine, Episodic Migraine, Migraine, Atogepant, Qulipta, Aquipta
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.
Interventions
DRUGAtogepant
Oral Tablet
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
CONTACTCeline Im
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed