Clinical trial NCT06603558: Post-Marketing Study to Assess the Safety and Effectiveness of Oral Atogepant in Korean Adult Participants for the Prevention of Chronic or Episodic Migraine
Official title: Post-marketing Surveillance Study to Evaluate the Safety and Effectiveness of Atogepant for the Prevention of Migraine in Korean Adult Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Migraine
Episodic Migraine
Migraine
Keywords: Chronic Migraine
Episodic Migraine
Migraine
Atogepant
Qulipta
Aquipta
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants who have been prescribed atogepant for preventive treatment migraine according to the latest approved local label in routine clinical practice.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage (%) of participants who reported serious adverse event (SAE)/drug reaction (SADR)
timeFrame: Up to approximately 16 Weeks
measure: Percentage (%) of participants who reported unexpected (not reflected in the latest approved label) adverse event (AE)/drug reaction (ADR)
timeFrame: Up to approximately 16 Weeks
measure: Percentage (%) of participants who reported known (labeled) ADR
timeFrame: Up to approximately 16 Weeks
measure: Percentage (%) of participants who reported non-serious AE/ADR
timeFrame: Up to approximately 16 Weeks
measure: Percentage (%) of participants who reported the events related to important potential risks and missing information defined in the Risk Management Plan (RMP)
timeFrame: Up to approximately 16 Weeks
measure: Percentage (%) of participants with AE: overall summary
timeFrame: Up to approximately 16 Weeks
measure: Percentage (%) of participants with common (>=5%) AE
timeFrame: Up to approximately 16 Weeks
measure: Percentage (%) of participants with AE leading to treatment discontinuation
timeFrame: Up to approximately 16 Weeks
measure: Percentage (%) of participants who reported treatment-related AE per the investigator causality assessment
timeFrame: Up to approximately 16 Weeks
measure: Percentage (%) of participants who reported treatment-related serious AE per the investigator causality assessment
timeFrame: Up to approximately 16 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hwaseong
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital /ID# 273581
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 271892
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital /ID# 271893
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 272639
state: Seoul Teugbyeolsi
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: