Registry to evaluate the safety of SUNOSI during pregnancy
SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring
This study is trying to see if the medication SUNOSI is safe for pregnant women who have narcolepsy or sleep apnea and how it affects their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1731 (estimated) |
| Sex | Female |
| Sponsor | Axsome Therapeutics, Inc. Industry-sponsored |
| Locations | 2 sites (Morrisville, North Carolina and 1 other locations) |
| Trial ID | NCT06413420 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this registry are pregnant women of any age who have narcolepsy or obstructive sleep apnea and have been prescribed solriamfetol or other wake-promoting medications.
Not a fit: Patients who have experienced pregnancy outcomes prior to their first contact with the registry will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide critical safety information that helps pregnant women and their healthcare providers make informed decisions about the use of solriamfetol.
How similar studies have performed: While this registry approach is observational, similar studies evaluating medication safety during pregnancy have shown success in providing valuable data for informed clinical decisions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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 Criteria: * 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 this trial is running
Morrisville, North Carolina and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.