SUNOSI® (Solriamfetol) Pregnancy Registry
SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring
Axsome Therapeutics, Inc.
1,731 participants
Jul 31, 2019
OBSERVATIONAL
Conditions
Summary
The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).
Eligibility
Inclusion Criteria5
- Pregnant women of any age
- 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 Criteria2
- Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)
- Inclusion of a prior pregnancy in the main analysis population
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Interventions
Exposure to at least 1 dose of solriamfetol at any time during pregnancy.
Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.
No treatment
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06413420