WAKIX® (Pitolisant) Pregnancy Registry

Recruiting now

Conditions studied: Pregnancy Related, Narcolepsy

In brief

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.

Key facts

Study ID

NCT05536011

Run by

Harmony Biosciences Management, Inc.

People needed

1329

Starts

2021-08-24

Expected to finish

2030-06-30

Last updated by the study team

2026-06-12

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• Evidera (PPD) — Morrisville, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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