WAKIX® (Pitolisant) Pregnancy Registry
WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring
Harmony Biosciences Management, Inc.
1,329 participants
Aug 24, 2021
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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)
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Interventions
Exposure to at least one dose of pitolisant at any time during pregnancy
Exposure to at least one dose of a comparator product at any time during pregnancy
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05536011