WAKIX® (Pitolisant) Pregnancy Registry

Last updated: January 24, 2024
Sponsor: Harmony Biosciences, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Narcolepsy

Treatment

Pitolisant

Comparator Products

Clinical Study ID

NCT05536011
HBS-101-CL-008
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Total Participants: 1329
Treatment Group(s): 2
Primary Treatment: Pitolisant
Phase:
Study Start date:
August 24, 2021
Estimated Completion Date:
June 30, 2030

Study 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.

Connect with a study center

  • Evidera (PPD)

    Morrisville, North Carolina 28403
    United States

    Active - Recruiting

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