WAKIX® (Pitolisant) Pregnancy Registry
NCT05536011 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1329
Last updated 2025-08-05
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.
Conditions
- Pregnancy Related
- Narcolepsy
Interventions
- DRUG
-
Exposure to at least one dose of pitolisant at any time during pregnancy
- DRUG
-
Comparator Products
Exposure to at least one dose of a comparator product at any time during pregnancy
Sponsors & Collaborators
-
Harmony Biosciences Management, Inc.
lead INDUSTRY
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-24
- Primary Completion
- 2030-06-30
- Completion
- 2030-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Exploration of Pregnant Women's Reluctance Toward COVID-19 Vaccination
NCT06968117 ·Status: COMPLETED
-
Evaluation of Pre-dose and Post-dose Anti-factor Xa Levels With Enoxaparin Use During Pregnancy
NCT00319176 ·Status: COMPLETED
-
The Nuvigil and Provigil Pregnancy Registry
NCT01792583 ·Status: TERMINATED
-
Clinical Outcomes of Pregnant Individuals With Epilepsy - Prospective Study
NCT05485649 ·Status: RECRUITING
-
The Cymbalta Pregnancy Registry
NCT01074151 ·Status: COMPLETED
-
A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy
NCT05503927 ·Status: ENROLLING_BY_INVITATION
-
Telocytes in Umbilical Cord of Patients With and Without Pre-eclampsia
NCT05305339 ·Status: UNKNOWN
-
Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process
NCT06303986 ·Status: ENROLLING_BY_INVITATION
-
Pregnancy and Risk of Venous Thromboembolism
NCT03659708 ·Status: RECRUITING ·Phase: NA
-
PROmega Pilot Study of Clinic-based DHA Blood Screening in Early Pregnancy
NCT07271758 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Fetal and Infant Effects of Maternal Buprenorphine Treatment
NCT01561079 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy
NCT04013399 ·Status: WITHDRAWN ·Phase: NA
-
Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy
NCT04856436 ·Status: COMPLETED
-
Evaluation of MHP 3.0 in Two Clinical Settings
NCT04863521 ·Status: UNKNOWN ·Phase: NA
-
VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination
NCT05570630 ·Status: COMPLETED ·Phase: NA
-
Telocytes in Placental Tissues of Patients With Gestational and Pre-gestational Diabetes
NCT05305326 ·Status: UNKNOWN
-
Sonoclot to Evaluate Thrombotic Risk in Proteinuric Pregnancy
NCT05108389 ·Status: UNKNOWN
-
COVID-19 International Drug Pregnancy Registry
NCT05013632 ·Status: RECRUITING
-
Preventing Lack of Iodine During Pregnancy
NCT00379535 ·Status: TERMINATED ·Phase: PHASE3
-
Exhaled NO as a Biomarker of Gestational OSA and Persistence Postpartum
NCT02100943 ·Status: COMPLETED
-
Venous Thromboembolism in Pregnancy Study
NCT00856076 ·Status: UNKNOWN
-
A Study to Describe Mothers' and Babies' Outcomes After Exposure to HyQvia During Pregnancy
NCT05803200 ·Status: COMPLETED
-
Non Invasive Prenatal Test of Rare Genetic Diseases: Application to Rare Intellectual Disabilities
NCT03688594 ·Status: UNKNOWN ·Phase: NA
-
COVID-19 Vaccines International Pregnancy Exposure Registry
NCT04705116 ·Status: RECRUITING
-
Development of an International Remote Digital Care System for Accessible, Inclusive and Sustainable Pregnancy Care
NCT07191236 ·Status: ENROLLING_BY_INVITATION