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
This trial does not accept healthy volunteersQualifiers
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 population
The study population will include pregnant women of any age who reside in a country where solriamfetol is available for the treatment of narcolepsy or OSA, provide consent to participate as well as medical releases for their healthcare providers (HCPs) to provide data to the registry, and meet the criteria for inclusion into 1 of the 5 cohorts.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Sunosi (solriamfetol)
DrugExposure to at least 1 dose of solriamfetol at any time during pregnancy.
Other prescription wake-promoting medications or stimulants
DrugExposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.
No treatment
Other interventionNo treatment
Treatment groups
1,731 Participants
are divided into 5 treatment groupsGroup A: Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA1 intervention
Group B: Cohort 2: Unexposed participants with narcolepsy or OSA1 intervention
Group C: Cohort 3: Other-exposed participants with narcolepsy or OSA1 intervention
Group D: Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA1 intervention
Group E: Cohort 5: Other-exposed participants without narcolepsy or OSA1 intervention
Trial outcomes
Primary outcomes
1
Long-term Safety
Time frame
Baseline up to 12 months after pregnancy outcomeSponsors and contacts
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Source ClinicalTrials.gov