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WAKIX® (Pitolisant) Pregnancy Registry

Recruitingn/aAges any - anyFemaleHarmony Biosciences Management, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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)
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What it tests

  • Pitolisant
  • Comparator Products
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Where

1 site
Evidera (PPD)
Morrisville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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