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
1731 participants
OBSERVATIONAL
2019-07-31
2029-09-30
Brief Summary
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Detailed Description
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The study collects health information from enrolled pregnant women and their healthcare providers related to their pregnancies and developing babies up to 1 year of age. The registry is strictly observational. Only data that are routinely documented in patients' medical records during the course of usual care will be collected.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
Sunosi (solriamfetol)
Exposure to at least 1 dose of solriamfetol at any time during pregnancy.
Cohort 2: Unexposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
No treatment
No treatment
Cohort 3: Other-exposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
Other prescription wake-promoting medications or stimulants
Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.
Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA
Pregnant women without a diagnosis of narcolepsy or OSA
Sunosi (solriamfetol)
Exposure to at least 1 dose of solriamfetol at any time during pregnancy.
Cohort 5: Other-exposed participants without narcolepsy or OSA
Pregnant women without a diagnosis of narcolepsy or OSA
Other prescription wake-promoting medications or stimulants
Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.
Interventions
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Sunosi (solriamfetol)
Exposure to at least 1 dose of solriamfetol at any time during pregnancy.
Other prescription wake-promoting medications or stimulants
Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.
No treatment
No treatment
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy
* Resident of a country where solriamfetol is available for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA
* Provides written informed consent to participate in the study
* Authorization for her HCP(s) to provide data to the registry
Exclusion Criteria
* Inclusion of a prior pregnancy in the main analysis population
FEMALE
No
Sponsors
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Axsome Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Evidera, a PPD business unit
Morrisville, North Carolina, United States
PPD, Inc.
Wilmington, North Carolina, United States
Countries
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Central Contacts
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Related Links
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Axsome Therapeutics Website
Sunosi Pregnancy Registry Recruitment Website
Other Identifiers
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JZP110-402
Identifier Type: -
Identifier Source: org_study_id
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