| NCT ID | NCT05536011 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Harmony Biosciences Management, Inc. |
| Condition | Pregnancy Related |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,329 participants |
| Start Date | 2021-08-24 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,329 participants in total. It began in 2021-08-24 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05536011 clinical trial?
This trial is open to female participants only, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05536011 currently recruiting?
Yes, NCT05536011 is actively recruiting participants. Contact the research team at wakixpregnancyregistry@ppd.com for enrollment information.
Where is the NCT05536011 trial being conducted?
This trial is being conducted at Morrisville, United States.
Who is sponsoring the NCT05536011 clinical trial?
NCT05536011 is sponsored by Harmony Biosciences Management, Inc.. The trial plans to enroll 1,329 participants.