WAKIX® (Pitolisant) Pregnancy Registry

Launched by HARMONY BIOSCIENCES MANAGEMENT, INC. · Sep 7, 2022

Keywords

ClinConnect Summary

The WAKIX® (pitolisant) Pregnancy Registry is a study looking at how the medication pitolisant, used for narcolepsy, affects pregnant women and their babies. Researchers want to understand if taking this medication during pregnancy has any effects on the mother's health, the baby's development, and other important outcomes after birth. This study is currently recruiting participants, and it is open to pregnant women of any age who are willing to give their consent and allow their doctors to share their information with the registry.

To be eligible for the study, women must either have narcolepsy and have taken pitolisant or a similar medication during pregnancy, or they must have taken pitolisant whether or not they have narcolepsy. If a participant has already had a pregnancy outcome before contacting the registry, they cannot join the study. Women who participate can expect to provide information about their health and pregnancy experiences, helping researchers gather important data to better understand the safety of pitolisant during pregnancy.

Gender

FEMALE

Eligibility criteria

• Inclusion 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
• Exclusion Criterion:
• • • Occurrence of pregnancy outcome prior to first contact with the Registry Coordination Center (RCC) (i.e., retrospectively enrolled)