WAKIX® (Pitolisant) Pregnancy Registry

Pregnancy Related Clinical Trial

Official title:

WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05536011
• Other study ID #: HBS-101-CL-008
• Status: Recruiting
• Start date: August 24, 2021
• Est. completion date: June 30, 2030

Study information

• Verified date: January 2024
• Source: Harmony Biosciences, LLC
• Contact: WAKIX Pregnancy Registry Associate
• Phone: 1-877-302-2813
• Email: wakixpregnancyregistry[@]ppd.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1329
• Est. completion date: June 30, 2030
• Est. primary completion date: June 30, 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criterion:

• Occurrence of pregnancy outcome prior to first contact with the Registry Coordination Center (RCC) (i.e., retrospectively enrolled)

Related Conditions & MeSH terms

• Narcolepsy
• Pregnancy Related

Intervention

Drug:
• Pitolisant
Exposure to at least one dose of pitolisant at any time during pregnancy
• Comparator Products
Exposure to at least one dose of a comparator product at any time during pregnancy

Locations

Country	Name	City	State
United States	Evidera (PPD)	Morrisville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Harmony Biosciences, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Enrollment through the infant's first year of life
Secondary	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.	Enrollment through the infant's first year of life
Secondary	Pre-eclampsia	High blood pressure and signs of liver or kidney damage occurring at >20 gestational weeks.	Enrollment through pregnancy outcome
Secondary	Eclampsia	Seizures or coma in a pregnant woman with pre-eclampsia.	Enrollment through pregnancy outcome
Secondary	Spontaneous abortion	An involuntary fetal loss or the expulsion of the products of conception occurring at <20 gestational weeks.	Enrollment through pregnancy outcome
Secondary	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.	Enrollment through pregnancy outcome
Secondary	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.	Enrollment through pregnancy outcome
Secondary	Preterm birth	A live birth occurring at <37 gestational weeks.	Enrollment through the infant's first year of life
Secondary	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.	Enrollment through the infant's first year of life
Secondary	Postnatal growth deficiency	Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts	Enrollment through the infant's first year of life
Secondary	Infant development deficiency	Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention (CDC).	Enrollment through the infant's first year of life