SUNOSI® (Solriamfetol) Pregnancy Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorAxsome Therapeutics, Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)
Inclusion of a prior pregnancy in the main analysis population
Trial design
Treatments tested in this trial
- Sunosi (solriamfetol)
- Other prescription wake-promoting medications or stimulants
- No treatment
Treatment groups
1,731 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov