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WAKIX® (Pitolisant) Pregnancy Registry
Sponsor: Harmony Biosciences Management, Inc.
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.
Official title: WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
1329
Start Date
2021-08-24
Completion Date
2030-06-30
Last Updated
2025-08-05
Healthy Volunteers
No
Conditions
Interventions
Pitolisant
Exposure to at least one dose of pitolisant at any time during pregnancy
Comparator Products
Exposure to at least one dose of a comparator product at any time during pregnancy
Locations (1)
Evidera (PPD)
Morrisville, North Carolina, United States