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Идёт набор 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

— Наблюдательное Chronic Migraine Episodic Migraine Migraine

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Atogepant.
Кому может быть актуально
Состояния в реестре: Chronic Migraine, Episodic Migraine, Migraine. Базовые параметры: от 19 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Post-marketing Surveillance Study to Evaluate the Safety and Effectiveness of Atogepant for the Prevention of Migraine in Korean Adult Patients

Обзор

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.

Вмешательства

  • Препарат Atogepant
    Oral Tablet

Первичные конечные точки

  • Percentage (%) of participants who reported serious adverse event (SAE)/drug reaction (SADR) [Срок оценки: Up to approximately 16 Weeks]
  • Percentage (%) of participants who reported unexpected (not reflected in the latest approved label) adverse event (AE)/drug reaction (ADR) [Срок оценки: Up to approximately 16 Weeks]
  • Percentage (%) of participants who reported known (labeled) ADR [Срок оценки: Up to approximately 16 Weeks]
  • Percentage (%) of participants who reported non-serious AE/ADR [Срок оценки: 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) [Срок оценки: Up to approximately 16 Weeks]
  • Percentage (%) of participants with AE: overall summary [Срок оценки: Up to approximately 16 Weeks]
  • Percentage (%) of participants with common (>=5%) AE [Срок оценки: Up to approximately 16 Weeks]
  • Percentage (%) of participants with AE leading to treatment discontinuation [Срок оценки: Up to approximately 16 Weeks]
  • Percentage (%) of participants who reported treatment-related AE per the investigator causality assessment [Срок оценки: Up to approximately 16 Weeks]
  • Percentage (%) of participants who reported treatment-related serious AE per the investigator causality assessment [Срок оценки: Up to approximately 16 Weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • Participants with any contraindication to atogepant as listed on the latest approved local label.
  • Participants currently participating in another clinical research except observational study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 36 центров
  • 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
  • … и ещё 28 центров

Идентификаторы

NCT: NCT06603558 · P24-480

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗