Actively Recruiting

FEMALE
NCT05536011

WAKIX® (Pitolisant) Pregnancy Registry

Led by Harmony Biosciences Management, Inc. · Updated on 2025-08-05

1329

Participants Needed

1

Research Sites

461 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

WAKIX® (Pitolisant) Pregnancy Registry

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant woman of any age
  • Consent to participate
  • Authorization for healthcare providers to provide data to the registry
  • For women with narcolepsy: exposure to pitolisant, comparator products, or no exposure during pregnancy
  • For women without narcolepsy: exposure to pitolisant or comparator products during pregnancy
Not Eligible

You will not qualify if you...

  • Pregnancy outcome occurred before first contact with the Registry Coordination Center (retrospective enrollment)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Evidera (PPD)

Morrisville, North Carolina, United States, 28403

Actively Recruiting

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Research Team

W

WAKIX Pregnancy Registry Associate

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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