Registry to evaluate pitolisant use during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The WAKIX Pregnancy Registry is a prospective, observational cohort study in the US that aims to assess the effects of pitolisant exposure during pregnancy on maternal, fetal, and infant outcomes. Pregnant women who consent to participate will have their data collected from routine medical records, with no additional tests required. The study includes women with and without narcolepsy who have been exposed to pitolisant or comparator products. The registry follows FDA guidelines for pregnancy exposure studies.

Why it matters

Who can join: the full rules

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)

Where it's running

• Evidera (PPD)
  Morrisville, North Carolina, United States Recruiting

Study contacts

• Study coordinator: WAKIX Pregnancy Registry Associate
• Email: wakixpregnancyregistry@ppd.com
• Phone: 1-877-302-2813

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.