Registry to evaluate the safety of SUNOSI during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SUNOSI Pregnancy Registry is a prospective, multi-country observational study aimed at assessing the safety of solriamfetol exposure in pregnant women diagnosed with narcolepsy or obstructive sleep apnea. This registry collects health information from enrolled participants and their healthcare providers regarding their pregnancies and the health of their babies up to one year of age. The data collected is strictly observational, relying on routine medical records to inform treatment decisions regarding solriamfetol during pregnancy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 or in the relevant exposure window before conception
* Resident of the US or Canada
* Provides written informed consent to participate in the study
* Authorization for her HCP(s) to provide data to the registry

Exclusion Criteria:

* Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)

Where it's running

• Evidera, a PPD business unit
  Morrisville, North Carolina, United States Recruiting
• PPD, Inc.
  Wilmington, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: sunosipregnancyregistry@ppd.com
• Phone: 1-877-283-6220

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.