Идёт набор NCT05536011

WAKIX® (Pitolisant) Pregnancy Registry

— Наблюдательное Pregnancy Related Narcolepsy

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: Pitolisant, Comparator Products.
Кому может быть актуально: Состояния в реестре: Pregnancy Related, Narcolepsy. Базовые параметры: Без ограничений · 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
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring

Обзор

Подробное описание

The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Participation in the registry is voluntary and participants can withdraw their consent to participate at any time. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable. The registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are routinely documented in patients' medical records during the course of usual care will be collected. No additional laboratory tests or HCP assessments will be required as part of this registry. The design of this pregnancy registry follows current FDA guidance for designing and implementing pregnancy exposure registries.

Вмешательства

Препарат Pitolisant
Exposure to at least one dose of pitolisant at any time during pregnancy
Препарат Comparator Products
Exposure to at least one dose of a comparator product at any time during pregnancy

Первичные конечные точки

Major congenital malformation [Срок оценки: Enrollment through the infant's first year of life]

Вторичные конечные точки (10)

Minor congenital malformation [Срок оценки: Enrollment through the infant's first year of life]
Pre-eclampsia [Срок оценки: Enrollment through pregnancy outcome]
Eclampsia [Срок оценки: Enrollment through pregnancy outcome]
Spontaneous abortion [Срок оценки: Enrollment through pregnancy outcome]
Stillbirth [Срок оценки: Enrollment through pregnancy outcome]
Elective termination [Срок оценки: Enrollment through pregnancy outcome]
Preterm birth [Срок оценки: Enrollment through the infant's first year of life]
Small for gestational age [Срок оценки: Enrollment through the infant's first year of life]
Postnatal growth deficiency [Срок оценки: Enrollment through the infant's first year of life]
Infant development deficiency [Срок оценки: Enrollment through the infant's first year of life]

Критерии участия

Критерии включения

Pregnant woman of any age
Consent to participate
Authorization for her HCP(s) to provide data to the registry
For participants with a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product, or, unexposed to pitolisant or comparator products at any time during pregnancy (i.e., any pregnant woman with a diagnosis of narcolepsy)
For participants without a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product at any time during pregnancy

Exclusion Criterion: