Actively Recruiting
SUNOSI® (Solriamfetol) Pregnancy Registry
Led by Axsome Therapeutics, Inc. · Updated on 2024-05-14
1731
Participants Needed
2
Research Sites
526 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
SUNOSI® (Solriamfetol) Pregnancy Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women of any age
- Diagnosed with narcolepsy or obstructive sleep apnea OR have taken solriamfetol or other wake-promoting medications or stimulants during pregnancy
- Resident of a country where solriamfetol is available for treating excessive daytime sleepiness related to narcolepsy or OSA
- Provides written informed consent to participate
- Authorizes healthcare providers to share medical data with the registry
You will not qualify if you...
- Pregnancy outcome occurred before first contact with the registry coordination center
- Prior pregnancy already included in the main analysis population
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Evidera, a PPD business unit
Morrisville, North Carolina, United States, 27560
Actively Recruiting
2
PPD, Inc.
Wilmington, North Carolina, United States, 28401
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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