WAKIX® (Pitolisant) Pregnancy Registry

Harmony Biosciences Management, Inc.

Status: Enrolling

Conditions: Pregnancy Related; Narcolepsy

Treatments: Drug: Comparator Products; Drug: Pitolisant

Study type: Observational

Funder types: Industry

Identifiers

NCT05536011

HBS-101-CL-008

Details and patient eligibility

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.

Full 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.

Enrollment: 1,329 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

1,329 participants in 5 patient groups

Pitolisant-exposed participants with narcolepsy

Description:

Pregnant women with a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy

Treatment:

Drug: Pitolisant

Unexposed participants with narcolepsy

Description:

Pregnant women with a diagnosis of narcolepsy who are not exposed to pitolisant or a comparator product at any time during pregnancy

Comparator-exposed participants with narcolepsy

Description:

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

Treatment:

Drug: Comparator Products

Pitolisant-exposed participants without narcolepsy

Description:

Pregnant women without a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy

Treatment:

Drug: Pitolisant

Comparator-exposed participants without narcolepsy

Description:

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

Treatment:

Drug: Comparator Products