WAKIX® (Pitolisant) Pregnancy Registry for Narcolepsy

This registry is observing pregnant women to understand the effects of WAKIX® (pitolisant) on mothers and their babies. You can join if you are pregnant and have narcolepsy, and have been exposed to pitolisant or another similar medication, or no medication, during your pregnancy. The study aims to see if there's a link between pitolisant exposure during pregnancy and major birth defects in the baby. The study is currently unclear on its recruitment status and plans to include about 1329 participants.

Study design: This is an observational study, meaning researchers will collect information without influencing your care. It is designed to follow a large group of pregnant women.
What's involved: You would give permission for your healthcare providers to share information from your routine medical records. No extra tests or doctor visits are required for this study.
Compensation: Not stated in the trial record.
Follow-up: Your baby's health will be followed from birth through their first year of life.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

WAKIX® (Pitolisant) Pregnancy Registry

Recruiting

Not specifiedAll AgesObservational

Harmony Biosciences Management, Inc.

~1,329 participants

Updated 2026-06-12 on ClinicalTrials.gov

What's tested:PitolisantComparator Products

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Major congenital malformation

Measured over Enrollment through the infant's first year of life

Conditions

Pregnancy Related

Narcolepsy

Where it's being run

1 sites across 1 states

North Carolina1

Who to contact

WAKIX Pregnancy Registry Associate

[email protected]

1-877-302-2813

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

What this trial measures

Major congenital malformationEnrollment through the infant's first year of life
An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.

Trialytics