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RECRUITING
NCT05536011

WAKIX® (Pitolisant) Pregnancy Registry

Sponsor: Harmony Biosciences Management, Inc.

View on ClinicalTrials.gov

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

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

Locations (1)

Evidera (PPD)

Morrisville, North Carolina, United States