Clinical Trial

WAKIX® (Pitolisant) Pregnancy Registry

Name: WAKIX® (Pitolisant) Pregnancy Registry — clinical trial record (NCT05536011)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Recruiting

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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.

Protocol Amendment History 3 amendments

This ClinicalTrials.gov record has been amended 3 times since 2022-09-07; most recent amendment 2026-06-10.

Trial Details

NCT Number	NCT05536011
Lead Sponsor	Harmony Biosciences Management, Inc.
Conditions	Pregnancy Related, Narcolepsy
Enrollment	1,329 participants
Start Date	2021-08-24
Primary Completion	2030-06-30 (estimated)
Study Completion	2030-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-12