SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring
Data Collection
Collected from today forward - ProspectiveApnea+9
+ Mental Disorders
+ Disorders of Excessive Somnolence
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: July 31, 2019
Actual date on which the first participant was enrolled.The goal of the registry is to provide information on the safety of solriamfetol during pregnancy so that patients and physicians can weigh the benefits and risks of exposure during pregnancy and make informed treatment decisions. The study collects health information from enrolled pregnant women and their healthcare providers related to their pregnancies and developing babies up to 1 year of age. The registry is strictly observational. Only data that are routinely documented in patients' medical records during the course of usual care will be collected.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1731 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Evidera, a PPD business unit
Morrisville, United StatesOpen Evidera, a PPD business unit in Google MapsPPD, Inc.
Wilmington, United States