SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Drug
Study Type: Observational
SUMMARY
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
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:
• 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
Locations
United States
North Carolina
Evidera, a PPD business unit
RECRUITING
Morrisville
PPD, Inc.
RECRUITING
Wilmington
Contact Information
Primary
Study Director
sunosipregnancyregistry@ppd.com
1-877-283-6220
Time Frame
Start Date: 2019-07-31
Estimated Completion Date: 2029-09
Participants
Target number of participants: 1731
Treatments
Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
Cohort 2: Unexposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
Cohort 3: Other-exposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA
Pregnant women without a diagnosis of narcolepsy or OSA
Cohort 5: Other-exposed participants without narcolepsy or OSA
Pregnant women without a diagnosis of narcolepsy or OSA
Related Therapeutic Areas
Sponsors
Leads: Axsome Therapeutics, Inc.