Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1329 participants
OBSERVATIONAL
2021-08-24
2030-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pitolisant-exposed participants with narcolepsy
Pregnant women with a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy
Pitolisant
Exposure to at least one dose of 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
No interventions assigned to this group
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
Comparator Products
Exposure to at least one dose of a comparator product 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
Pitolisant
Exposure to at least one dose of 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
Comparator Products
Exposure to at least one dose of a comparator product at any time during pregnancy
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
FEMALE
No
Sponsors
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Harmony Biosciences Management, Inc.
INDUSTRY
Responsible Party
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Locations
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Evidera (PPD)
Morrisville, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Kristin Veley, PharmD, MPH
Role: primary
Other Identifiers
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HBS-101-CL-008
Identifier Type: -
Identifier Source: org_study_id
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