RecruitingNCT05536011

WAKIX® (Pitolisant) Pregnancy Registry

WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring


Sponsor

Harmony Biosciences Management, Inc.

Enrollment

1,329 participants

Start Date

Aug 24, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Comparator Products and a drug called Pitolisant for people with narcolepsy and pregnancy related. The study is currently recruiting participants at 1 location. People eligible for this study include women.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPitolisant

Exposure to at least one dose of pitolisant at any time during pregnancy

DRUGComparator 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

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NCT05536011


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