WAKIX® (Pitolisant) Pregnancy Registry

Description

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

Pregnancy Related, Narcolepsy

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Study Overview

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Study Details

Study overview

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.

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

WAKIX® (Pitolisant) Pregnancy Registry

Condition
Pregnancy Related
Intervention / Treatment

-

Contacts and Locations

Morrisville

Evidera (PPD), Morrisville, North Carolina, United States, 28403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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

Ages Eligible for Study

to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Harmony Biosciences, LLC,

Study Record Dates

2030-06-30