Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atogepant | Participants will receive atogepant as prescribed by their physician according to the local label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atogepant | Drug | Oral Tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult participants who have been prescribed atogepant for preventive treatment migraine according to the latest approved local label in routine clinical practice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celine Im | Contact | +82-10-2230-3629 | celine.im@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Dongtan Sacred Heart Hospital /ID# 273581 | Recruiting | Hwaseong | Gyeonggido | 18450 | South Korea | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Seoul National University Hospital /ID# 271892 |
| Recruiting |
| Seoul |
| Seoul Teugbyeolsi |
| 03080 |
| South Korea |
| Kangbuk Samsung Hospital /ID# 271893 | Recruiting | Seoul | Seoul Teugbyeolsi | 03181 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 272639 | Recruiting | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718987 | atogepant |
Not provided
Not provided
Not provided