WAKIX® (Pitolisant) Pregnancy Registry
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: Pitolisant, Comparator Products.
- Who it may be relevant to
- Registry conditions: Pregnancy Related, Narcolepsy. Basic parameters: No limits · Female.
- 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
- United States
- 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
WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring
Overview
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.
Detailed description
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.
Interventions
- Drug Pitolisant
Exposure to at least one dose of pitolisant at any time during pregnancy - Drug Comparator Products
Exposure to at least one dose of a comparator product at any time during pregnancy
Primary outcome measures
- Major congenital malformation [Time frame: Enrollment through the infant's first year of life]
Secondary outcome measures (10)
- Minor congenital malformation [Time frame: Enrollment through the infant's first year of life]
- Pre-eclampsia [Time frame: Enrollment through pregnancy outcome]
- Eclampsia [Time frame: Enrollment through pregnancy outcome]
- Spontaneous abortion [Time frame: Enrollment through pregnancy outcome]
- Stillbirth [Time frame: Enrollment through pregnancy outcome]
- Elective termination [Time frame: Enrollment through pregnancy outcome]
- Preterm birth [Time frame: Enrollment through the infant's first year of life]
- Small for gestational age [Time frame: Enrollment through the infant's first year of life]
- Postnatal growth deficiency [Time frame: Enrollment through the infant's first year of life]
- Infant development deficiency [Time frame: Enrollment through the infant's first year of life]
Eligibility criteria
Inclusion criteria
- 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:
- Occurrence of pregnancy outcome prior to first contact with the Registry Coordination Center (RCC) (i.e., retrospectively enrolled)
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
United States · 1 center
- Evidera (PPD) — Morrisville
Identifiers
NCT: NCT05536011 · HBS-101-CL-008