SUNOSI® (Solriamfetol) Pregnancy Registry

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06413420
Study type	Observational [Patient Registry]
Source	Axsome Therapeutics, Inc.
Contact	Study Director
Phone	1-877-283-6220
Email	sunosipregnancyregistry@ppd.com
Status	Recruiting
Phase
Start date	July 31, 2019
Completion date	September 2029

View Details

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