Actively Recruiting
SUNOSI (Solriamfetol) Pregnancy Registry: Observational Study on Solriamfetol Safety in Pregnant Women with Narcolepsy or Obstructive Sleep Apnea
Led by Axsome Therapeutics, Inc. · Updated on 2024-05-14
1731
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety of solriamfetol exposure during pregnancy in women diagnosed with narcolepsy or obstructive sleep apnea (OSA). This observational registry aims to collect valuable information to help patients and doctors make informed decisions about treatment during pregnancy. The study is conducted across multiple countries and focuses on evaluating the potential risks of solriamfetol use in this population. The study includes pregnant women who either have narcolepsy or OSA or have taken solriamfetol or other wake-promoting medications or stimulants during pregnancy. Participants are grouped based on their exposure to solriamfetol, other similar medications, or no treatment. This registry is strictly observational, meaning it collects only health data recorded during usual medical care and does not assign treatments. Participants and their healthcare providers provide routine health information about the pregnancies and the development of the babies up to one year of age. The study monitors long-term safety outcomes from baseline through 12 months after the pregnancy outcome. No additional procedures or interventions are performed beyond regular care, and the total participation duration includes follow-up for one year after birth.
CONDITIONS
Brief 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 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 associated with narcolepsy or OSA
- Provides written informed consent to participate in the study
- Authorization for her healthcare providers to provide data to 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for enrollment and informed consent
Duration - From enrollment through pregnancy outcome
Participants who undergo routine care are observed. Health information related to their pregnancies and developing babies is collected from medical records.
Data collected during routine healthcare visits
Duration - Up to 12 months after pregnancy outcome
Participants and their babies are followed for up to 1 year after pregnancy outcome to monitor safety.
Assessments collected during routine postnatal healthcare visits
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
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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