Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603558
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
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:
None
Organization:
None
Study Overview
Official Title:
Post-marketing Surveillance Study to Evaluate the Safety and Effectiveness of Atogepant for the Prevention of Migraine in Korean Adult Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Atogepant PMSS
Brief Summary:
Migraine is a neurological disease characterized by moderate or severe headache associated with nausea vomiting andor 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None