An observational study in Pregnancy Related and Narcolepsy, sponsored by Harmony Biosciences Management, Inc.. Recruiting at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Harmony Biosciences Management, Inc. (part of Harmony Biosciences Holdings, Inc.) · Observational
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.
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. Participation in the registry is voluntary and participants can withdraw their consent to participate at any time. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable. The registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are routinely documented in patients' medical records during the course of usual care will be collected. No additional laboratory tests or HCP assessments will be required as part of this registry. The design of this pregnancy registry follows current FDA guidance for designing and implementing pregnancy exposure registries.
157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.
This study's planned enrollment of 1,329 is above the median of 135 across 38 observational studies indexed under Narcolepsy.
Browse Narcolepsy studies →Harmony Biosciences Management, Inc. is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
The narcolepsy study population will include three cohorts (cohort 1, 2 and 3) of pregnant women with a diagnosis of narcolepsy:
The non-narcolepsy study population will include two cohorts (cohorts 4 and 5) of pregnant women without a diagnosis of narcolepsy:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criterion:
Pregnant women with a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy
Drug: Pitolisant
Pregnant women with a diagnosis of narcolepsy who are not exposed to pitolisant or a comparator product at any time during pregnancy
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
Drug: Comparator Products
Pregnant women without a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy
Drug: Pitolisant
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
Drug: Comparator Products
Exposure to at least one dose of pitolisant at any time during pregnancy
Also known as: Wakix
Exposure to at least one dose of a comparator product at any time during pregnancy
Also known as: Modafinil/armodafinil, Sodium oxybate, Oxybate mixed salts, Solriamfetol, Methylphenidate, Amphetamines
Major congenital malformation
An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.
Time frame: Enrollment through the infant's first year of life
Minor congenital malformation
An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual.
Time frame: Enrollment through the infant's first year of life
Pre-eclampsia
High blood pressure and signs of liver or kidney damage occurring at \>20 gestational weeks.
Time frame: Enrollment through pregnancy outcome
Eclampsia
Seizures or coma in a pregnant woman with pre-eclampsia.
Time frame: Enrollment through pregnancy outcome
Spontaneous abortion
An involuntary fetal loss or the expulsion of the products of conception occurring at \<20 gestational weeks.
Time frame: Enrollment through pregnancy outcome
Stillbirth
As defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring at ≥20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥350 g.
Time frame: Enrollment through pregnancy outcome
Elective termination
A voluntary fetal loss or interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health or due to fetal abnormalities.
Time frame: Enrollment through pregnancy outcome
Preterm birth
A live birth occurring at \<37 gestational weeks.
Time frame: Enrollment through the infant's first year of life
Small for gestational age
Weight, length, or head circumference at birth in \<10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.
Time frame: Enrollment through the infant's first year of life
Postnatal growth deficiency
Weight, length, or head circumference in \<10th percentile for sex and chronological age using standard growth charts
Time frame: Enrollment through the infant's first year of life
Infant development deficiency
Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention (CDC).
Time frame: Enrollment through the infant's first year of life
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Harmony Biosciences Management, Inc. →