Trials / Recruiting
RecruitingNCT05536011
WAKIX® (Pitolisant) Pregnancy Registry
WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,329 (estimated)
- Sponsor
- Harmony Biosciences Management, Inc. · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pitolisant | Exposure to at least one dose of pitolisant at any time during pregnancy |
| DRUG | Comparator Products | Exposure to at least one dose of a comparator product at any time during pregnancy |
Timeline
- Start date
- 2021-08-24
- Primary completion
- 2030-06-30
- Completion
- 2030-06-30
- First posted
- 2022-09-10
- Last updated
- 2025-08-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05536011. Inclusion in this directory is not an endorsement.