Recruiting

WAKIX

Sponsor:

Harmony Biosciences Management, Inc.

Code:

NCT05536011

Conditions

Pregnancy Related

Narcolepsy

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Pitolisant

Comparator Products

Study Details

Brief 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

Study ID

NCT05536011

Start date

Aug 24, 2021

Status verified date

Jun, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

1329 participants

Anticipated

Interventions and Outcome Measures

Arms

Pitolisant-exposed participants with narcolepsy

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

Unexposed participants with narcolepsy

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

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

Pitolisant-exposed participants without narcolepsy

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

Comparator-exposed participants without narcolepsy

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

Interventions

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

Primary outcome measure

  • Major congenital malformation [ Time Frame: Enrollment through the infant's first year of life ]

Central Contacts and Locations

Central contacts

WAKIX Pregnancy Registry Associate

1-877-302-2813wakixpregnancyregistry@ppd.com

Locations

Evidera (PPD)

Recruiting

Morrisville, North Carolina, United States, 28403

More Information

Sponsor

Harmony Biosciences Management, Inc.

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Harmony Biosciences Management, Inc. on 2026-06-12.