Registry to evaluate pitolisant use during pregnancy
WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring
This study is trying to see how using pitolisant during pregnancy affects mothers and their babies, and it's open to pregnant women with and without narcolepsy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1329 (estimated) |
| Sex | Female |
| Sponsor | Harmony Biosciences Management, Inc. Industry-sponsored |
| Locations | 1 site (Morrisville, North Carolina) |
| Trial ID | NCT05536011 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pregnant women of any age who have been exposed to pitolisant or comparator products.
Not a fit: Patients who have already experienced pregnancy outcomes prior to contacting the registry will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the safety and effects of pitolisant during pregnancy, guiding treatment decisions for pregnant women with narcolepsy.
How similar studies have performed: While observational studies on medication exposure during pregnancy are common, this specific registry approach for pitolisant is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Morrisville, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.