SUNOSI® (Solriamfetol) Pregnancy Registry

Recruiting now

Conditions studied: Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring

In brief

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).

Key facts

Study ID

NCT06413420

Run by

Axsome Therapeutics, Inc.

People needed

1731

Starts

2019-07-31

Expected to finish

2029-09-01

Last updated by the study team

2024-05-14

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)
• Inclusion of a prior pregnancy in the main analysis population

Where it is running

• Evidera, a PPD business unit — Morrisville, North Carolina, United States (enrolling)
• PPD, Inc. — Wilmington, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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