Post-Marketing Study to Assess the Safety and Effectiveness of Oral Atogepant in Korean Adult Participants for the Prevention of Chronic or Episodic Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atogepant.
- Who it may be relevant to
- Registry conditions: Chronic Migraine, Episodic Migraine, Migraine. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post-marketing Surveillance Study to Evaluate the Safety and Effectiveness of Atogepant for the Prevention of Migraine in Korean Adult Patients
Overview
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
- Drug Atogepant
Oral Tablet
Primary outcome measures
- Percentage (%) of participants who reported serious adverse event (SAE)/drug reaction (SADR) [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) [Time frame: Up to approximately 16 Weeks]
- Percentage (%) of participants who reported known (labeled) ADR [Time frame: Up to approximately 16 Weeks]
- Percentage (%) of participants who reported non-serious AE/ADR [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 Risk Management Plan (RMP) [Time frame: Up to approximately 16 Weeks]
- Percentage (%) of participants with AE: overall summary [Time frame: Up to approximately 16 Weeks]
- Percentage (%) of participants with common (>=5%) AE [Time frame: Up to approximately 16 Weeks]
- Percentage (%) of participants with AE leading to treatment discontinuation [Time frame: Up to approximately 16 Weeks]
- 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 serious AE per the investigator causality assessment [Time frame: Up to approximately 16 Weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 36 centers
- On Hospital /ID# 285157 — Busan
- Ryu Sang Hyo Neurosurgery Clinic /ID# 284804 — Busan
- Dong-A University Medical Center /ID# 275321 — Busan
- Chungnam National University Hospital /ID# 284724 — Daejeon
- Chuncheon Sacred Heart Hospital /ID# 275315 — Gangwon-do
- Chonnam National University Hospital /ID# 275318 — Gwangju
- Korea University Ansan Hospital /ID# 284725 — Ansan-si
- Inje University - Ilsan Paik Hospital /ID# 280738 — Goyang
- … and 28 more centers
Identifiers
NCT: NCT06603558 · P24-480