WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:
• 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
Locations
United States
North Carolina
Evidera (PPD)
RECRUITING
Morrisville
Contact Information
Primary
WAKIX Pregnancy Registry Associate
wakixpregnancyregistry@ppd.com
1-877-302-2813
Time Frame
Start Date:2021-08-24
Estimated Completion Date:2030-06-30
Participants
Target number of participants:1329
Treatments
Pitolisant-exposed participants with narcolepsy
Pregnant women with a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy
Unexposed participants with narcolepsy
Pregnant women with a diagnosis of narcolepsy who are not exposed to pitolisant or a comparator product at any time during pregnancy
Comparator-exposed participants with narcolepsy
Pregnant women with a diagnosis of narcolepsy who are not exposed to pitolisant at any time during pregnancy but who are exposed to comparator products at any time during pregnancy
Pitolisant-exposed participants without narcolepsy
Pregnant women without a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy
Comparator-exposed participants without narcolepsy
Pregnant women without a diagnosis of narcolepsy who are not exposed to pitolisant at any time during pregnancy but who are exposed to a comparator product at any time during pregnancy