Actively Recruiting
WAKIX® (Pitolisant) Pregnancy Registry
Led by Harmony Biosciences Management, Inc. · Updated on 2025-08-05
1329
Participants Needed
1
Research Sites
461 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
WAKIX® (Pitolisant) Pregnancy Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant woman of any age
- Consent to participate
- Authorization for healthcare providers to provide data to the registry
- For women with narcolepsy: exposure to pitolisant, comparator products, or no exposure during pregnancy
- For women without narcolepsy: exposure to pitolisant or comparator products during pregnancy
You will not qualify if you...
- Pregnancy outcome occurred before first contact with the Registry Coordination Center (retrospective enrollment)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Evidera (PPD)
Morrisville, North Carolina, United States, 28403
Actively Recruiting
Research Team
W
WAKIX Pregnancy Registry Associate
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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