WAKIX® (Pitolisant) Pregnancy Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorHarmony Biosciences Management, Inc.
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
None
Trial design
Treatments tested in this trial
- Pitolisant
- Comparator Products
Treatment groups
1,329 Participants
are divided into 5 treatment groupsLocations
1Evidera (PPD)28403, MorrisvilleNorth Carolina, United States
Sponsors and collaborators
Harmony Biosciences Management, Inc.
Lead sponsor
Source ClinicalTrials.gov