WAKIX® (Pitolisant) Pregnancy Registry

Part of paid clinical trials in Morrisville, North Carolina.

Sponsor
Harmony Biosciences Management, Inc.
Study ID
NCT05536011
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 24, 2021
Status verified
Jul 2025
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
1,329 participants (estimated)

Arms

  • Arm: Pitolisant-exposed participants with narcolepsy
    Pregnant women with a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy
  • Arm: 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
  • Arm: 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
  • Arm: Pitolisant-exposed participants without narcolepsy
    Pregnant women without a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy
  • Arm: 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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Evidera (PPD)MorrisvilleNorth Carolina28403
Kristin Veley, PharmD, MPH

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