Идёт набор NCT05158894

Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy

— Наблюдательное 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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Migraine. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Канада
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

The Ubrelvy and Qulipta Pregnancy Exposure Registry EMPRESS: An Observational, Prospective Study to Assess the Safety of Ubrelvy (Ubrogepant) and Qulipta (Atogepant) During Pregnancy

Обзор

Migraine is a common neurological disorder typically characterized by attacks of throbbing or pulsating headache on one side of the head of moderate to severe pain intensity. The purpose of this study is to evaluate fetal, maternal, and infant outcomes through 12 months of age among women exposed to Ubrelvy or Qulipta during pregnancy, as well as in 2 comparator groups. Ubrelvy (ubrogepant) and Qulipta (atogepant) are approved drugs for the acute treatment of migraine in adults. Approximately 628 pregnant women with migraine exposed to Ubrelvy, 628 pregnant women with migraine exposed to Qulipta and 628 pregnant women with migraine in comparator group will be enrolled in this study in the United States. Participants enrolled in the Ubrelvy-exposed group and Qulipta-exposed group will receive Ubrelvy and Qulipta respectively as prescribed by their physician.

Первичные конечные точки

Major Congenital Malformations (MCMs) [Срок оценки: Up through the first 12 months of life]

Вторичные конечные точки (11)

Percentage of Pregnant Participants Experiencing Spontaneous Abortion [Срок оценки: Up through the first 12 months of life]
Percentage of Pregnant Participants Experiencing Stillbirth [Срок оценки: Up through the first 12 months of life]
Percentage of Pregnant Participants With Elective Termination [Срок оценки: Up through the first 12 months of life]
Percentage of Pregnant Participants Experiencing Preeclampsia [Срок оценки: Up through the first 12 months of life]
Percentage of Pregnant Participants Experiencing Eclampsia [Срок оценки: Up through the first 12 months of life]
Percentage of Pregnant Participants Experiencing Gestational Hypertension [Срок оценки: Up through the first 12 months of life]
Percentage of Pregnant Participants Experiencing Gestational Diabetes [Срок оценки: Up through the first 12 months of life]
Percentage of Infants Experiencing Preterm Birth [Срок оценки: Up through the first 12 months of life]
Percentage of Infants Experiencing Small for Gestational Age (SGA) Birth [Срок оценки: Up through the first 12 months of life]
Percentage of Infants Experiencing Minor Malformations [Срок оценки: Up through the first 12 months of life]
Percentage of Infants With Age-appropriate Infant Growth and Development [Срок оценки: Up through the first 12 months of life]

Критерии участия

Критерии включения

Within the United States or Canada.
Qualify as a prospective enrollment, defined as currently pregnant.
A diagnosis of migraine by the patient's health care provider (HCP).
Provide contact information for the participant and her and her infant(s)', if applicable, HCPs.
Authorize their HCP(s) to release maternal and infant medical information to the registry, upon request.
Provide sufficient information to confirm eligibility for 1 of following:

Ubrelvy-exposed women with migraine: documented information indicating that at least 1 dose of Ubrelvy was taken during pregnancy, including the estimated number of administrations per trimester.
Qulipta-exposed women with migraine: documented information to indicating that at least 1 dose of Qulipta was taken during pregnancy, including start and stop date(s) of administration.
Internal comparator: Ubrelvy/Qulipta-unexposed pregnant women with migraine: documented information indicating that they have, a) never taken Ubrelvy and/or Qulipta, or b) discontinued Ubrelvy 2 days prior or Qulipta 5 days prior to conception.

Критерии исключения

Documentation of exposure to any gepants (acute or preventive) other than Ubrelvy and Qulipta, or CGRP monoclonal antibodies, from 5 halflives of the respective treatment prior to conception or at any point during pregnancy before enrollment.
Women who are no longer pregnant (retrospective cases women for whom the pregnancy has already ended, and the outcome of pregnancy is known at the time of enrollment).
For further clarification of inclusion/exclusion please contact the investigator to the end of this section in case anything is unclear to a potential patient, etc

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

Здоровые добровольцы: Нет